Abstract
Persons with schizophrenia have reduced cardiorespiratory fitness (CRF), a predictor of all-cause mortality. Exercise is effective for improving CRF; however, motivational challenges affecting those with schizophrenia impact exercise engagement and maintenance. Virtual Physical Activity Can Enhance Life (Virtual PACE-Life), a multicomponent walking intervention guided by self-determination theory (SDT), was developed to target CRF in this population while addressing motivational difficulties. Virtual PACE-Life includes live video-delivered group walking sessions, Fitbit activity tracking, recommendations for home-based walking sessions, goal setting, and if-then plans. The present study was a 16-week pilot randomized controlled trial that evaluated the impact of Virtual PACE-Life against Fitbit Alone in a sample of 37 participants with schizophrenia on intermediate targets (competence, autonomy, and relatedness satisfaction, autonomous motivation), proximal outcomes (Fitbit-measured steps/day and minutes spent walking), and the primary outcome (CRF using the 6-minute walk test). Blinded research staff completed assessments at baseline, midpoint, posttest, and one-month follow-up. Analysis of covariance and hierarchical linear regression analyses were used to evaluate group differences at each timepoint controlling for baseline. Attendance at Virtual PACE-Life groups was 58% and Fitbit adherence was above 70% in both conditions. Intent-to-treat results indicated greater competence and autonomy satisfaction for Virtual PACE-Life but not in relatedness satisfaction or autonomous motivation. There were no group differences in proximal or primary outcomes during the intervention period. Completer analyses showed improvements in steps/day and autonomous motivation favoring Virtual PACE-Life. Future research is needed to maximize the exercise and CRF benefits of virtual group-based exercise for persons with schizophrenia.
Keywords: video-delivered, remote, exercise, cardiorespiratory fitness, self-determination theory
Introduction
Physical inactivity and high levels of sedentary behavior contribute to cardiovascular disease development and early death among adults with schizophrenia (Andersen et al., 2018; Correll et al., 2017; Olfson et al., 2015; Scheewe et al., 2019). According to a large meta-analysis of 69 studies (Vancampfort et al., 2017), persons with serious mental illness (schizophrenia, bipolar disorder, major depressive disorder) are sedentary for nearly eight hours/day and are less likely to meet physical activity guidelines of 150 minutes/week of moderate-intensity exercise than persons without these mental health challenges. Further, a schizophrenia diagnosis was associated with both lower physical activity amounts and not meeting physical activity guidelines (Vancampfort et al., 2017), thereby highlighting that this population is at especially high risk for reduced health-promoting behaviors even above other serious mental illnesses. Physical inactivity, in turn, is linked to cardiorespiratory fitness (CRF), a marker shown to predict all-cause mortality (Laukkanen et al., 2022) that is significantly lower among those with schizophrenia compared to the general population (Vancampfort et al., 2017). Taken together, exercise interventions designed to improve CRF are critical to support the physical health of those with schizophrenia.
Research examining exercise and lifestyle programs for those with schizophrenia have highlighted that various types of aerobic exercise modalities (e.g., gym-based, treadmill walking/jogging, cycling, etc.) are effective at improving CRF in this population (Bartels et al., 2013; Bartels et al., 2015; Dauwan et al., 2016; Firth et al., 2015; Rosenbaum et al., 2014; Schmitt et al., 2018; Vancampfort et al., 2015). Accumulating evidence from small open trials (Browne et al., 2016; Browne et al., 2021) and one pilot randomized trial (Kern et al., 2020) suggest that group-based outdoor walking programs meaningfully improve CRF, which is encouraging given the accessibility of these interventions. In addition to eliminating the need for gym access and equipment, group-based walking programs also facilitate opportunities for social connection and support, which are critical given associations between loneliness and physical inactivity in those with schizophrenia (Vancampfort et al., 2012). Despite the established benefits of exercise on CRF and particular value of group-based walking programs for those with schizophrenia, initial and sustained engagement in exercise programs remains low for this population (Tumiel et al., 2019; Vancampfort et al., 2016).
One of the major barriers to initiation and maintenance of exercise among those with schizophrenia is low motivation, which may be due to negative symptoms, physical health comorbidities that make exercise uncomfortable, and/or low confidence in their ability to make health changes (Browne, Mihas, & Penn, 2016; Firth et al., 2016; Vancampfort et al., 2013). As such, exercise interventions designed for this population should consider motivation as a critical ingredient to maximize health benefits and long-term changes. Self-determination theory (SDT) is a theory of motivation that has been used as a framework for designing exercise-based interventions (Teixeira et al., 2012). SDT posits that behavior is driven by three basic psychological needs: autonomy, competence, and relatedness and that creating an environment that allows for need fulfilment can result in autonomous motivation (Deci & Ryan, 2008; Ryan & Deci, 2000). Therefore, exercise interventions that support individuals in satisfying these needs can increase self-determined or autonomous motivation for engagement and ultimately translate into changes in exercise behavior (Ntoumanis et al., 2021; Sheeran et al., 2020, 2021; Teixeira et al., 2012). In fact, autonomous motivation has been shown to be associated with physical activity level in persons with schizophrenia (Vancampfort et al., 2015; Vancampfort et al., 2013), thereby suggesting the potential value of targeting motivation when seeking to increase physical activity in this group.
The purpose of the present study was to evaluate the impact of Physical Activity Can Enhance Life (PACE-Life), an SDT theory-based walking intervention, on CRF in adults with schizophrenia in the context of a 16-week pilot randomized controlled trial (RCT). To date, open trials of PACE-Life have shown positive results in terms of increased exercise behavior and CRF (Browne et al., 2021; Orleans-Pobee et al., 2021); however, none of these prior studies evaluated PACE-Life against a comparison condition. The primary aim of this pilot RCT was to examine group differences in intermediate targets (SDT needs, autonomous motivation), proximal outcomes (steps/day and minutes spent walking from Fitbit), and the primary outcome (CRF). We hypothesized that participants randomized to PACE-Life would experience greater benefits in all outcomes compared to a Fitbit Alone control condition.
Methods
Study Design and Overview
The present study was a two-arm parallel pilot RCT conducted in [STATE]. All participants provided written informed consent and this study was approved by the [UNIVERSITY] Institutional Review Board. The CONSORT guidelines for pilot randomized trials were consulted for study design and reporting (Eldridge et al., 2016). This pilot RCT was registered on clinicaltrials.gov [NCT NUMBER].
The study initially began in January 2020 as an RCT of an in-person version of PACE-Life versus a Fitbit Alone control condition. However, all research activities were halted in March 2020 due to the start of the COVID-19 pandemic.1 Due to uncertainty surrounding resumption of in-person activities, PACE-Life was modified into a virtual version and an RCT of this virtual version was subsequently conducted.
The present paper describes the methods and results of the RCT of Virtual PACE-Life versus Fitbit Alone. The first participant was enrolled in January of 2021 and the final participant completed the follow-up assessment in March 2022.
Participants
Adults aged 18-65 years old were recruited from local outpatient community mental health centers primarily through clinician referrals. Participants who had previously consented to future outreach from research staff about studies were also contacted to assess interest and eligibility. Study inclusion criteria were (a) diagnosis of schizophrenia spectrum disorder (i.e., schizophrenia, schizoaffective disorder, brief psychotic disorder, schizophreniform disorder, or unspecified schizophrenia spectrum and other psychotic disorder) based on the Mini International Neuropsychiatric Interview (Sheehan et al., 1998), (b) greater than a 4th grade reading level as measured by the Wide Range Achievement Test (Wilkinson, 1993), (c) clinically stable defined as no psychiatric hospitalizations in the past three months and no psychiatric medication changes in the prior month, (d) not regularly engaging in moderate-intensity exercise (cutoff = 60 min/week over the prior six months), and (e) safe to participate in the exercise program based on the Physical Activity Readiness Questionnaire (PAR-Q) (American College of Sports Medicine & Pescatello, 2014) and a physical examination by the study physician (consultation with the participant’s primary care physician was conducted as needed).
Interventions
Virtual PACE-Life.
Virtual PACE-Life is a live, video-delivered, SDT theory-based, multicomponent walking intervention aimed at improving CRF by engaging the intermediate targets (SDT needs, autonomous motivation) to increase the proximal outcomes (steps/day and minutes spent walking). Rooted in SDT, each of PACE-Life’s five components target one of the basic needs of competence, autonomy, and relatedness or autonomous motivation. Specifically, PACE-Life is comprised of: (a) moderate-intensity group-based virtual walking sessions (targets relatedness by providing opportunities for social support and interaction in a group setting), (b) recommendations for moderate-intensity home-based walking (targets autonomy by encouraging participants to choose the location and day/time of their home-based walks), (c) activity tracking with Fitbit devices (targets competence by promoting review and acknowledgment of exercise progress in the form of steps/day), (d) goal setting (targets competence by promoting achievable exercise targets that complement activity tracking), and (e) if-then plans (targets autonomous motivation by identifying personalized barriers to exercise and solutions to overcome these barriers in service of overarching exercise goals).
Group-based virtual walking sessions were held twice per week via Zoom with at least two group leaders present. Groups were modeled after walk-at-home videos used in prior studies (Abrantes et al., 2017, 2021). To elicit an exercise dose-response aimed to produce physical and health benefits, the volume and intensity of the exercise progressed from low-volume low-intensity to moderate-volume moderate-intensity by the end of the intervention. The goal of the intervention was to have participants achieve the recommended levels of physical activity for maintenance or improvements in overall health (Piercy et al., 2018). Group sessions began with a warm-up of walking in place and then consisted of low impact walking-based movements such as walking forward and back, side steps, front and back kicks, and knee raises. Group leaders were able to customize the sequences of movements. Groups ended with a cooldown period involving guided stretching. Two types of metrics were used to guide walking intensity: (1) heart rate reserve using the Karvonen method (Díaz-Buschmann et al., 2014) and (2) rate of perceived exertion (RPE) (Borg, 1973), a self-report scale (6-20) of exercise difficulty. Participants were provided with individualized heart rate zone targets each week based on their age and resting heart rate as well as a recommendation for the target RPE for exercise. Group leaders asked participants to check their HR and rate their RPE every 10 minutes during group sessions and encouraged modifications should these reports be outside the recommended ranges. Group leaders were mental health professionals, graduate students in clinical psychology, and undergraduate students majoring in exercise and sports science. All group leaders received four hours of training in PACE-Life delivery prior to the start of the intervention and attended weekly supervision calls led by the lead author. Virtual walking sessions were monitored for fidelity (at least 50% of sessions reviewed) and feedback was provided to group leaders.
In addition to groups, participants received recommendations for frequency and duration of home-based walking sessions each week, which could be completed by walking indoors/outdoors or by viewing freely available virtual walking sessions online. All aspects of the exercise program (except for frequency of groups) increased in a stepwise fashion over the course of the 16 weeks to maximize health benefits and ensure participant safety. Groups were held twice/week throughout the entire 16 weeks to promote accessibility (Table 1).
Table 1.
Virtual PACE-Life Schedule
| Week | Frequency of Virtual Group Sessions | Duration of Virtual Group Sessions | Frequency of Home-based Walking Sessions | Duration of Home-based Walking Sessions | Intensity | RPE |
|---|---|---|---|---|---|---|
| 1 | 2 | 15 minutes | 0 | 15 minutes | 50-60% of HRR | 10-12 |
| 2 | 2 | 15 minutes | 0 | 15 minutes | 50-60% of HRR | 10-12 |
| 3 | 2 | 20 minutes | 1 | 20 minutes | 50-65% of HRR | 10-12 |
| 4 | 2 | 20 minutes | 1 | 20 minutes | 50-65% of HRR | 10-12 |
| 5 | 2 | 20 minutes | 1 | 20 minutes | 60-65% of HRR | 12-13 |
| 6 | 2 | 20 minutes | 1 | 20 minutes | 60-65% of HRR | 12-13 |
| 7 | 2 | 25 minutes | 2 | 25 minutes | 60-65% of HRR | 13-14 |
| 8 | 2 | 25 minutes | 2 | 25 minutes | 60-65% of HRR | 13-14 |
| 9 | 2 | 25 minutes | 2 | 25 minutes | 60-65% of HRR | 13-14 |
| 10 | 2 | 30 minutes | 2 | 30 minutes | 60-65% of HRR | 13-14 |
| 11 | 2 | 30 minutes | 2 | 30 minutes | 60-65% of HRR | 13-14 |
| 12 | 2 | 30 minutes | 2 | 30 minutes | 60-65% of HRR | 13-14 |
| 13 | 2 | 30 minutes | 3 | 30 minutes | 65-70% of HRR | 13-15 |
| 14 | 2 | 30 minutes | 3 | 30 minutes | 65-70% of HRR | 13-15 |
| 15 | 2 | 30 minutes | 3 | 30 minutes | 65-70% of HRR | 13-15 |
| 16 | 2 | 30 minutes | 3 | 30 minutes | 65-70% of HRR | 13-15 |
Note. HRR = heart rate reserve; RPE = rate of perceived exertion.
At the start of the second group each week, participants set walking goals for the upcoming week that included (a) a target number of daily steps and (b) a target number of home-based walking sessions. Group leaders facilitated these discussions and encouraged participants to identify where and when they would complete the home-based walking sessions. All goal-setting discussions were audiotaped and at least 50% were assessed for fidelity. Independently through an online survey, participants identified barriers of group attendance and of completing home-based walking sessions as well as solutions for overcoming such barriers. They created if-then plans (Gollwitzer & Sheeran, 2006) of these barriers and solutions in the format of “if (barrier), then (solution)” Participants completed if-then plans for group attendance during the second week and for home-based walking sessions during the ninth week.
Fitbit Alone.
The Fitbit Alone condition involved receipt of a Fitbit device and instructions for use and constitutes an active control condition given that self-monitoring is known to promote physical activity (Harkin et al., 2016).
Measures
Intermediate targets and the primary outcome were assessed at baseline, midpoint (8 weeks), posttest (16 weeks), and one-month follow-up (20 weeks). Proximal outcomes were captured continuously by Fitbit devices.
Intermediate targets.
The intermediate targets of SDT needs and autonomous motivation were assessed with three self-report scales: The Basic Psychological Needs Scale – In General (BPNS; Deci & Ryan, 2000; Gagne, 2003), The Basic Psychological Needs in Exercise Scale (BPNES; Vlachopoulos & Michailidou, 2006), and the Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2; Markland & Tobin, 2016). The BPNS and BPNES provide scores for satisfaction of the SDT needs of autonomy, competence, and relatedness with the BPNES focused on these needs in the context of exercise. The relative autonomy index (RAI) of the BREQ-2 was used as the measure of autonomous motivation for exercise. All three measures have been shown to have adequate psychometric properties (Johnston & Finney, 2010; Vlachopoulos & Michailidou, 2006; Wilson et al., 2002); however, reliability and validity of these measures have not been specifically evaluated in the schizophrenia population.
Proximal outcomes.
The proximal outcomes of steps/day and minutes spent walking were obtained from Fitbit devices. Steps/day were captured daily from Fitbits whenever the device was worn and charged. Minutes spent walking were captured from Fitbits for any walking that lasted at least 15 minutes. These outcomes were recorded daily beginning one week prior to the start of group-based walking sessions (i.e., baseline) until the end of the follow-up period. Weekly averages corresponding to the assessment visits (i.e., baseline, 8, 16, and 20 weeks) were calculated when there was at least one day of valid data (defined as accumulating at least 300 steps). If participants did not have data at that specific timepoint, we used the closest timepoint with valid data within three weeks of that particular assessment point. Reliability and validity of Fitbit devices has been mixed with some work indicating the potential for underestimation of exercise behavior (Feehan et al., 2018). Despite these limitations, Fitbit trackers were included in the present study given that they have been well-tolerated in prior work with the schizophrenia population (Browne et al., 2021; Naslund et al., 2016; Orleans-Pobee et al., 2021) and were a core component of the exercise programs tested in this RCT.
Primary outcome.
The primary outcome of CRF was assessed with the six-minute walk test (6MWT; Cahalin, Mathier, Semigran, Dec, & DiSalvo, 1996; Vancampfort et al., 2011), which is a submaximal measure (Ross et al., 2010) in which individuals walk for six minutes covering as much ground as possible. The 6MWT was administered indoors where participants were encouraged to walk as quickly as possible around a 45.72 meters rectangular course. The total distance in meters covered in the six minutes was recorded. The 6MWT has been shown to have adequate reliability and validity in individuals with schizophrenia (Gomes et al., 2016).
Procedure
Participants were provided with the option to complete assessments in person or virtually considering the COVID-19 pandemic. All measures were administered through either modality except for the 6MWT, which could only be administered in person. As such, participants that elected to complete assessments virtually did not complete the 6MWT. After completing the baseline assessment, participants were randomized 1:1 to Virtual PACE-Life or Fitbit Alone for a 16-week intervention period plus a one-month follow-up period. The random allocation sequence was created using a computer-generated program. An unblinded research assistant provided participants with their intervention assignment (Virtual PACE-Life or Fitbit Alone) and reviewed information on the Fitbit Charge HR device including instructions for use, charging, and syncing data to their Fitbit account (created by the research team). Participants randomized to Virtual PACE-Life were provided with a tablet and data plan if they did not have the technology and/or Internet capability to access groups on their own. Two cohorts (n=20; n=17) were run consecutively. All assessments were completed by a trained research assistant blind to condition (Research assistant accuracy for guessing participant intervention condition was 65%). All Fitbit and technology-related questions (in addition to provision of random assignment) were managed by an unblinded research assistant.
Data Analysis
Intervention adherence was calculated for Fitbit usage (within each condition) and for attendance at group-based walking sessions (in Virtual PACE-Life). Fitbit adherence was defined as the percentage of days the Fitbit device was worn (i.e., having taken at least 300 steps) out of the total possible days. Group attendance was defined as the percentage of group-based walking sessions attended out of the total possible walking sessions. Fitbit adherence and group attendance rates were calculated first for each participant and then a group average was subsequently calculated.
Both cohorts were combined for all analyses. We used intent-to-treat principles to analyze the data, so any respondent with at least two datapoints were included and analyzed as part of the group in which they were originally assigned, regardless of intervention dosage and adherence. Analyses were conducted in the R statistical environment on complete datasets (i.e., participants had datapoints in each timepoint used in the analyses). First, we report means and standard deviations of each outcome at each timepoint. Then, we use analysis of covariance (ANCOVA) to examine differences between intervention and the control group at midpoint, posttest, and follow-up, controlling for baseline differences (Van Breukelen, 2006). We fit hierarchical linear regression models for each outcome and saved the R2 each time a new variable was introduced. Predictors in the models were added sequentially by first including the baseline score (to control for baseline differences), then the intervention effect (to examine the main effect of the intervention), and at each step the R2 for each model was saved. The R2 change (ΔR2) in the inclusion of the intervention variable was calculated and reported. Given our small sample size, it is unlikely that relations found among the variables or probing for interactions would be statistically significant. Therefore, we interpreted any relations in which the intervention had an ΔR2 ≥ .020, which represents a small effect size (Cohen, 1988; Lakens, 2013). In this case, we plotted the group-specific slopes and used them to interpret the nature of the relations (Supplementary materials) and estimated the conditional mean difference (Mdiff) of the intervention using the regression coefficient of the intervention indicator in the full model. We report 95% confidence intervals (CI) for all variables that had an ΔR2 ≥ .020. We also examined the percentage of participants who experienced clinically meaningful changes during the intervention period in the proximal and primary outcomes based on the following pre-specified values: proximal outcomes (steps/day: ≥2,000 steps/day, minutes spent walking: ≥150 minutes/week of walking) and primary outcome (6MWT: >50 meters).
A post-hoc completer analysis was also conducted to evaluate the impact of Virtual PACE-Life group attendance on outcomes. Specifically, ANCOVA and regression analyses were re-run to compare group differences between the subset of Virtual PACE-Life participants who attended 50% or more of the group-based walking sessions and the entire Fitbit Alone group, controlling for baseline.
Results
Participants
Seventy-three individuals were screened for inclusion. Thirty-six were excluded due to not meeting inclusion criteria, lost to contact after screening, or declining participation, thereby leaving 37 participants who met the inclusion criteria and agreed to participate. These 37 participants were randomized (Virtual PACE-Life: n=17, Fitbit Alone: n = 20). In terms of assessment completion (in-person or virtually), all participants completed the baseline assessment, at least 80% completed mid-and posttest assessments, and 75-88% completed the one-month follow-up assessment. Of the completed assessments, primary outcome data (6MWT) were available only for those participants that completed in-person assessments (62% at baseline, 60% at midpoint, 64% at posttest, and 63% at follow-up) (Figure 1). Demographic and clinical characteristics did not differ between conditions except for race. There was a smaller percentage of Black participants and higher percentage of White participants in the Fitbit Alone condition compared to Virtual PACE-Life. Across both groups, approximately half the sample was female, and the average age was 41 years old. Most participants identified as Not Hispanic or Latinx, were unemployed, had attended at least some college, were taking antipsychotic medications, and were not currently smoking (Table 2).
Figure 1.

Consort Diagram
a One additional participant did not complete posttest but returned for follow-up assessment. As such, this person was not categorized as lost to follow-up and is not included in the above figure.
bThe primary outcome was only able to be administered during in-person assessments. As such, proportions of completed in-person assessments reported in parentheses reflect completion of the primary outcome.
Table 2.
Demographic and Clinical Information
| Characteristic | Virtual PACE-Life (n=17) |
Fitbit Alone (n=20) |
|---|---|---|
|
| ||
| Age, M (SD) | 41.76 (11.72) | 41.05 (13.64) |
|
| ||
| Gender, n (%) | ||
| Male | 8 (47) | 11 (55) |
| Female | 9 (53) | 9 (45) |
|
| ||
| Race, n (%) | ||
| Black or African American | 7 (41) | 5 (25) |
| White | 8 (47) | 14 (70) |
| Mixed | 2 (12) | 1 (5) |
|
| ||
| Ethnicity, n (%) | ||
| Hispanic or Latinx | 4 (24) | 1 (5) |
| Not Hispanic or Latinx | 13 (76) | 19 (95) |
|
| ||
| Occupation, n (%) | ||
| Employed | 6 (35) | 2 (10) |
| Unemployed | 11 (65) | 14 (70) |
| Student | 0 (0) | 4 (20) |
|
| ||
| Education, n (%) | ||
| High school degree or equivalent | 2 (12) | 4 (20) |
| Some college | 7 (41) | 8 (40) |
| College degree | 6 (35) | 6 (30) |
| Higher than college | 2 (12) | 2 (10) |
|
| ||
| Taking Antipsychotic Medication, n (%) | ||
| Yes | 17 (100) | 17 (85) |
| No | 0 (0) | 3 (15) |
|
| ||
| Currently Smoking, n (%) | ||
| Yes | 3 (18) | 5 (25) |
| No | 14 (82) | 15 (75) |
Intervention Fidelity and Participant Adherence
In terms of fidelity to Virtual PACE-Life, 100% of rated group-based walking sessions contained at least 4/6 required elements; 82% of rated sessions contained all six required elements. Further, 100% of rated goal-setting discussions contained at least 5/6 required elements; 44% of rated discussions contained all six required elements.
In terms of participant adherence, the mean Fitbit adherence was 78.6% is the Virtual PACE-Life group and 74.1% in the Fitbit Alone group. Attendance was 55.8% for the group-based walking sessions in Virtual PACE-Life.
Group Differences in Outcomes
Unconditional means (i.e., means not controlling for baseline) and standard deviations for the outcomes are presented in Table three. Outcomes that had ΔR2 ≥ .020 are reported in detail below (See Table 3 for all ΔR2 values).
Table 3.
Unconditional Means of the Intermediate Targets, Proximal Outcomes, and Primary Outcome for Virtual PACE-Life and Fitbit Alone
| Virtual PACE-Life | Fitbit Alone | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Measure | Timepoint | N | Mean | SD | Min | Max | N | Mean | SD | Min | Max |
| BPNS Autonomy | Baseline | 17 | 4.908 | 1.233 | 2.286 | 7.000 | 20 | 4.693 | 0.715 | 3.143 | 5.857 |
| Midpoint | 16 | 5.000 | 0.991 | 3.000 | 6.286 | 19 | 4.549 | 0.905 | 3.000 | 6.000 | |
| Posttest | 15 | 4.543 | 1.278 | 1.286 | 6.714 | 16 | 4.768 | 0.911 | 3.286 | 6.286 | |
| Follow-up | 15 | 4.733 | 1.190 | 3.143 | 7.000 | 15 | 4.848 | 0.780 | 3.857 | 6.143 | |
|
| |||||||||||
| BPNS Relatedness | Baseline | 17 | 5.353 | 0.897 | 3.750 | 6.875 | 20 | 5.450 | 0.950 | 4.250 | 7.000 |
| Midpoint | 16 | 5.109 | 0.862 | 3.250 | 6.125 | 19 | 5.086 | 0.916 | 3.000 | 6.750 | |
| Posttest | 15 | 5.000 | 0.966 | 3.625 | 6.625 | 16 | 4.922 | 1.147 | 3.125 | 7.000 | |
| Follow-up | 15 | 5.000 | 1.023 | 3.250 | 7.000 | 15 | 5.067 | 1.372 | 2.875 | 7.000 | |
|
| |||||||||||
| BPNS Competence | Baseline | 17 | 4.490 | 1.139 | 2.500 | 6.167 | 20 | 4.458 | 1.246 | 2.500 | 7.000 |
| Midpoint | 16 | 4.802 | 0.999 | 2.500 | 6.500 | 19 | 4.158 | 0.917 | 2.500 | 6.000 | |
| Posttest | 15 | 4.911 | 0.882 | 3.167 | 6.333 | 16 | 4.271 | 1.312 | 2.000 | 7.000 | |
| Follow-up | 15 | 4.578 | 0.902 | 3.000 | 6.000 | 15 | 4.378 | 1.346 | 2.167 | 7.000 | |
|
| |||||||||||
| BPNES Autonomy | Baseline | 17 | 3.044 | 1.216 | 1.000 | 5.000 | 20 | 3.538 | 1.074 | 1.250 | 5.000 |
| Midpoint | 16 | 3.641 | 0.796 | 2.250 | 5.000 | 19 | 3.487 | 0.956 | 1.000 | 4.750 | |
| Posttest | 15 | 3.467 | 0.990 | 2.000 | 5.000 | 16 | 3.812 | 0.704 | 2.250 | 5.000 | |
| Follow-up | 15 | 3.450 | 1.111 | 1.250 | 5.000 | 15 | 3.717 | 0.925 | 1.750 | 5.000 | |
|
| |||||||||||
| BPNES Relatedness | Baseline | 17 | 2.922 | 1.326 | 1.000 | 5.000 | 20 | 2.417 | 1.544 | 1.000 | 5.000 |
| Midpoint | 16 | 3.104 | 1.354 | 1.000 | 5.000 | 19 | 2.491 | 1.525 | 1.000 | 5.000 | |
| Posttest | 15 | 3.000 | 1.254 | 1.000 | 4.667 | 16 | 3.333 | 1.388 | 1.000 | 5.000 | |
| Follow-up | 15 | 2.622 | 1.402 | 1.000 | 5.000 | 15 | 2.444 | 1.395 | 1.000 | 5.000 | |
|
| |||||||||||
| BPNES Competence | Baseline | 17 | 2.750 | 1.149 | 1.500 | 4.750 | 20 | 2.850 | 1.344 | 1.000 | 5.000 |
| Midpoint | 16 | 3.594 | 0.790 | 2.250 | 5.000 | 19 | 2.921 | 1.134 | 1.000 | 4.750 | |
| Posttest | 15 | 3.017 | 1.120 | 1.000 | 4.500 | 16 | 2.969 | 0.991 | 1.250 | 4.750 | |
| Follow-up | 15 | 3.100 | 0.967 | 1.750 | 4.750 | 15 | 3.383 | 1.121 | 1.500 | 5.000 | |
|
| |||||||||||
| BREQ-RAI | Baseline | 17 | 7.010 | 7.886 | −14.250 | 17.250 | 20 | 5.279 | 7.709 | −5.500 | 18.000 |
| Midpoint | 16 | 8.391 | 7.230 | −13.250 | 17.333 | 19 | 5.961 | 6.404 | −7.583 | 16.167 | |
| Posttest | 15 | 5.689 | 7.336 | −11.917 | 17.167 | 16 | 5.589 | 5.357 | −3.500 | 15.417 | |
| Follow-up | 15 | 6.600 | 8.472 | −16.000 | 17.333 | 15 | 7.950 | 4.962 | −2.833 | 15.000 | |
|
| |||||||||||
| Minutes Spent Walking | Baseline | 17 | 31.647 | 40.812 | 0.000 | 110.000 | 18 | 44.278 | 88.842 | 0.000 | 316.000 |
| Midpoint | 16 | 78.500 | 94.809 | 0.000 | 292.000 | 19 | 82.947 | 149.957 | 0.000 | 623.000 | |
| Posttest | 15 | 55.867 | 83.874 | 0.000 | 289.000 | 16 | 58.188 | 149.560 | 0.000 | 584.000 | |
| Follow-up | 12 | 43.500 | 83.645 | 0.000 | 270.000 | 12 | 180.833 | 456.068 | 0.000 | 1609.000 | |
|
| |||||||||||
| Steps/day | Baseline | 17 | 4940.529 | 4463.869 | 915.000 | 16322.000 | 18 | 5010.667 | 3487.757 | 751.000 | 13022.000 |
| Midpoint | 16 | 5547.688 | 3304.624 | 689.000 | 11288.000 | 19 | 4934.158 | 3253.810 | 764.000 | 10216.000 | |
| Posttest | 14 | 4274.429 | 3039.565 | 1368.000 | 10447.000 | 16 | 4503.875 | 3860.307 | 339.000 | 13431.000 | |
| Follow-up | 13 | 3720.769 | 2438.491 | 1552.000 | 10097.000 | 14 | 5791.429 | 7272.731 | 729.000 | 29884.000 | |
|
| |||||||||||
| 6-Minute Walk Test | Baseline | 12 | 458.775 | 91.467 | 327.100 | 617.500 | 11 | 467.209 | 83.828 | 354.800 | 636.100 |
| Midpoint | 11 | 468.445 | 99.444 | 303.300 | 594.400 | 9 | 434.711 | 52.507 | 316.100 | 487.700 | |
| Posttest | 11 | 452.355 | 103.346 | 297.200 | 619.700 | 9 | 448.711 | 59.594 | 317.600 | 514.500 | |
| Follow-up | 11 | 451.836 | 89.743 | 309.400 | 609.600 | 8 | 482.425 | 70.483 | 358.100 | 568.800 | |
Note. SD = standard deviation; BPNS = Basic Psychological Needs Scale – In General; BPNES = Basic Psychological Needs in Exercise Scale; RAI = Relative Autonomy Index
In terms of intermediate targets, participants in Virtual PACE-Life had higher competence satisfaction at all timepoints compared to participants in the Fitbit Alone group after adjusting for baseline (Midpoint: BPNS Mdiff =.712, 95% CI: .26, 1.17; BPNES Mdiff = .85, 95% CI: .37, 1.33; Posttest: BPNS Mdiff = .677, 95% CI: .17, 1.18; BPNES Mdiff = .302, 95% CI: −.12, .73; Follow-up: BPNS Mdiff = .511, 95% CI: −.05, 1.07), except for competence satisfaction in exercise at follow-up. Compared to participants in the Fitbit Alone group, participants in Virtual PACE-Life had higher autonomy satisfaction in general (BPNS Mdiff = .396, 95% CI: −.20, .99) and for exercise (BPNES Mdiff = .502, 95% CI: .03, .98) at midpoint only. At posttest, participants in the Fitbit Alone group had higher relatedness satisfaction in exercise than participants in Virtual PACE-Life (BPNES Mdiff = −.448, 95% CI: −1.22, .33). There were no group differences in BPNS relatedness or autonomous motivation as measured by the BREQ-RAI.
In terms of proximal outcomes, participants in the Virtual PACE-Life group had fewer steps/day than participants in the Fitbit Alone group at follow-up (Steps/day Mdiff = −1812 steps, 95% CI: −6175.74, 2552.44). There were no group differences in minutes spent walking. A small percentage of participants achieved clinically meaningful increases in steps/day defined as ≥2,000 steps/day: Virtual PACE-Life: 21.4%; Fitbit Alone: 6.7%. Forty-one percent of participants in Virtual PACE-Life and 35% in the Fitbit Alone achieved the pre-specified clinically meaningful number of minutes spent walking of ≥150 minutes/week in any week during the final six weeks of the intervention; however, none achieved this amount during all six weeks.
In terms of the primary outcome, participants in the Fitbit Alone group had higher CRF than those in the Virtual PACE-Life group at follow-up (6MWT Mdiff = −39.51, 95% CI: −80.68, 1.67) (Table 4). A small percentage of the sample achieved clinically meaningful increases in 6MWT during the intervention period (Virtual PACE-Life: 20.0%; Fitbit Alone: 11.1%).
Table 4.
R2 values from a linear regression model predicting timepoint estimate from baseline and R2 change after including the treatment variable.
| Midpoint | Posttest | Follow-up | ||||
|---|---|---|---|---|---|---|
|
| ||||||
| R2 base | ΔR2 int | R2 base | ΔR2 int | R2 base | ΔR2 int | |
| BPNS Autonomy | 0.135 | 0.043 | 0.199 | 0.014 | 0.300 | 0.008 |
| BPNS Relatedness | 0.358 | 0.007 | 0.394 | 0.008 | 0.564 | 0.006 |
| BPNS Competence | 0.423 | 0.130 | 0.553 | 0.089 | 0.524 | 0.051 |
| BPNES Autonomy | 0.355 | 0.076 | 0.395 | 0.000 | 0.237 | 0.001 |
| BPNES Relatedness | 0.543 | 0.015 | 0.320 | 0.030 | 0.601 | 0.001 |
| BPNES Competence | 0.377 | 0.170 | 0.670 | 0.021 | 0.721 | 0.015 |
| BREQ RAI | 0.608 | 0.017 | 0.604 | 0.005 | 0.641 | 0.009 |
| Minutes Spent Walking | 0.087 | 0.000 | 0.476 | 0.005 | 0.545 | 0.004 |
| Steps/day | 0.594 | 0.008 | 0.305 | 0.000 | 0.066 | 0.026 |
| 6-minute walk test | 0.587 | 0.011 | 0.684 | 0.005 | 0.691 | 0.059 |
Note. base = baseline; int = intervention; bold indicates ΔR2 ≥ .020.
Post-hoc Completer Analysis
Unconditional means and standard deviations for the outcomes for completers are reported in Table six. Outcomes that had ΔR2 ≥ .020 are reported in detail below (See Table 4 for all ΔR2 values).
Table 6.
Unconditional Means of the Intermediate Targets, Proximal Outcomes, and Primary Outcome for Virtual PACE-Life Completers and Fitbit Alone
| PACE-Life Completers | Fitbit Alone | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Measure | Timepoint | N | Mean | SD | Min | Max | N | Mean | SD | Min | Max |
| BPNS Autonomy | Baseline | 9 | 4.587 | 1.200 | 2.286 | 6.429 | 20 | 4.693 | 0.715 | 3.143 | 5.857 |
| Midpoint | 9 | 4.746 | 0.992 | 3.000 | 5.714 | 19 | 4.549 | 0.905 | 3.000 | 6.000 | |
| Posttest | 8 | 4.000 | 1.248 | 1.286 | 5.571 | 16 | 4.768 | 0.911 | 3.286 | 6.286 | |
| Follow-up | 8 | 4.268 | 1.009 | 3.143 | 6.286 | 15 | 4.848 | 0.780 | 3.857 | 6.143 | |
|
| |||||||||||
| BPNS Relatedness | Baseline | 9 | 5.278 | 0.814 | 3.750 | 6.250 | 20 | 5.450 | 0.950 | 4.250 | 7.000 |
| Midpoint | 9 | 4.917 | 0.929 | 3.250 | 6.125 | 19 | 5.086 | 0.916 | 3.000 | 6.750 | |
| Posttest | 8 | 4.812 | 0.894 | 3.625 | 6.125 | 16 | 4.922 | 1.147 | 3.125 | 7.000 | |
| Follow-up | 8 | 4.750 | 0.694 | 3.250 | 5.500 | 15 | 5.067 | 1.372 | 2.875 | 7.000 | |
|
| |||||||||||
| BPNS Competence | Baseline | 9 | 4.574 | 1.031 | 3.000 | 6.167 | 20 | 4.458 | 1.246 | 2.500 | 7.000 |
| Midpoint | 9 | 4.889 | 0.965 | 3.333 | 6.500 | 19 | 4.158 | 0.917 | 2.500 | 6.000 | |
| Posttest | 8 | 4.875 | 0.899 | 3.167 | 6.333 | 16 | 4.271 | 1.312 | 2.000 | 7.000 | |
| Follow-up | 8 | 4.625 | 0.77 | 3.833 | 6.000 | 15 | 4.378 | 1.346 | 2.167 | 7.000 | |
|
| |||||||||||
| BPNES Autonomy | Baseline | 9 | 3.194 | 1.298 | 1.250 | 4.500 | 20 | 3.538 | 1.074 | 1.250 | 5.000 |
| Midpoint | 9 | 3.583 | 0.74 | 2.750 | 5.000 | 19 | 3.487 | 0.956 | 1.000 | 4.750 | |
| Posttest | 8 | 3.344 | 1.043 | 2.000 | 4.500 | 16 | 3.812 | 0.704 | 2.250 | 5.000 | |
| Follow-up | 8 | 3.281 | 1.285 | 1.250 | 5.000 | 15 | 3.717 | 0.925 | 1.750 | 5.000 | |
|
| |||||||||||
| BPNES Relatedness | Baseline | 9 | 3.185 | 1.271 | 1.000 | 5.000 | 20 | 2.417 | 1.544 | 1.000 | 5.000 |
| Midpoint | 9 | 2.963 | 1.522 | 1.000 | 5.000 | 19 | 2.491 | 1.525 | 1.000 | 5.000 | |
| Posttest | 8 | 2.875 | 1.414 | 1.000 | 4.667 | 16 | 3.333 | 1.388 | 1.000 | 5.000 | |
| Follow-up | 8 | 2.625 | 1.24 | 1.000 | 4.000 | 15 | 2.444 | 1.395 | 1.000 | 5.000 | |
|
| |||||||||||
| BPNES Competence | Baseline | 9 | 2.694 | 1.151 | 1.500 | 4.500 | 20 | 2.850 | 1.344 | 1.000 | 5.000 |
| Midpoint | 9 | 3.583 | 0.781 | 2.250 | 5.000 | 19 | 2.921 | 1.134 | 1.000 | 4.750 | |
| Posttest | 8 | 3.250 | 0.813 | 2.000 | 4.000 | 16 | 2.969 | 0.991 | 1.250 | 4.750 | |
| Follow-up | 8 | 3.219 | 0.92 | 2.000 | 4.250 | 15 | 3.383 | 1.121 | 1.500 | 5.000 | |
|
| |||||||||||
| BREQ-RAI | Baseline | 9 | 3.389 | 8.805 | −14.250 | 12.917 | 20 | 5.279 | 7.709 | −5.500 | 18.000 |
| Midpoint | 9 | 6.815 | 8.997 | −13.250 | 15.333 | 19 | 5.961 | 6.404 | −7.583 | 16.167 | |
| Posttest | 8 | 4.458 | 8.835 | −11.917 | 12.667 | 16 | 5.589 | 5.357 | −3.500 | 15.417 | |
| Follow-up | 8 | 5.135 | 10.996 | −16.000 | 17.333 | 15 | 7.950 | 4.962 | −2.833 | 15.000 | |
|
| |||||||||||
| Minutes Spent Walking | Baseline | 9 | 38.444 | 44.722 | 0.000 | 103.000 | 18 | 44.278 | 88.842 | 0.000 | 316.000 |
| Midpoint | 9 | 97.556 | 83.002 | 20.000 | 241.000 | 19 | 82.947 | 149.957 | 0.000 | 623.000 | |
| Posttest | 9 | 81.333 | 98.462 | 0.000 | 289.000 | 16 | 58.188 | 149.560 | 0.000 | 584.000 | |
| Follow-up | 7 | 65.429 | 104.567 | 0.000 | 270.000 | 12 | 180.833 | 456.068 | 0.000 | 1609.000 | |
|
| |||||||||||
| Steps/day | Baseline | 9 | 4423.222 | 2135.971 | 915.000 | 7768.000 | 18 | 5010.667 | 3487.757 | 751.000 | 13022.000 |
| Midpoint | 9 | 6059.556 | 2785.85 | 1474.000 | 10293.000 | 19 | 4934.158 | 3253.810 | 764.000 | 10216.000 | |
| Posttest | 8 | 5690.000 | 3360.654 | 1413.000 | 10447.000 | 16 | 4503.875 | 3860.307 | 339.000 | 13431.000 | |
| Follow-up | 7 | 4729.714 | 2895.158 | 1734.000 | 10097.000 | 14 | 5791.429 | 7272.731 | 729.000 | 29884.000 | |
|
| |||||||||||
| 6-Minute Walk Test | Baseline | 6 | 456.683 | 103.887 | 327.100 | 617.500 | 11 | 467.209 | 83.828 | 354.800 | 636.100 |
| Midpoint | 6 | 461.017 | 127.476 | 303.300 | 594.400 | 9 | 434.711 | 52.507 | 316.100 | 487.700 | |
| Posttest | 5 | 440.62 | 136.422 | 297.200 | 619.700 | 9 | 448.711 | 59.594 | 317.600 | 514.500 | |
| Follow-up | 5 | 450.74 | 116.69 | 309.400 | 609.600 | 8 | 482.425 | 70.483 | 358.100 | 568.800 | |
Note. SD = standard deviation; BPNS = Basic Psychological Needs Scale – In General; BPNES = Basic Psychological Needs in Exercise Scale; RAI = Relative Autonomy Index
Nine participants randomized to Virtual PACE-Life attended 50% or more of the group-based walking sessions and thus were labeled as “completers.” Completer analyses were consistent with results in the overall sample for intermediate targets of competence satisfaction in general and in exercise (at all three timepoints), relatedness satisfaction in general and in exercise (at all three timepoints), and autonomy satisfaction in exercise (at midpoint and follow-up), autonomous motivation (at posttest and follow-up), minutes spent walking (at all three timepoints), and the six-minute walk test (at all three timepoints).
Completer results diverged from the overall sample for intermediate targets of autonomy satisfaction in general (at all three timepoints) and in exercise (at posttest), autonomous motivation (at midpoint), and steps/day (at all three timepoints). Specifically, completer analyses showed no differences in autonomy satisfaction in general at midpoint but showed that participants in the Fitbit Alone group had higher autonomy satisfaction in general at posttest (BPNS Mdiff=−.695, 95% CI: −1.57, .18) and follow-up (BPNS Mdiff=−.507, 95% CI: −1.21, .19) as well as higher autonomy satisfaction in exercise at posttest (BPNES Mdiff=−.281, 95% CI: −.86, .29) compared to those in Virtual PACE-Life. Autonomous motivation measured by the BREQ-RAI was higher in Virtual PACE-Life at midpoint (Mdiff=2.659, 95% CI −.96, 6.28) compared to Fitbit Alone. Participants in Virtual PACE-Life had higher steps/day at midpoint (Mdiff=1543.680, 95% CI −187.49, 3274.85) and posttest (Mdiff=1627.553, 95% CI: −721.64, 3976.75) compared to Fitbit Alone; however, no differences were observed at follow-up (Table 5).
Table 5.
R2 values from a linear regression model predicting timepoint estimate from baseline and R2 change after including the treatment variable for individuals who completed at least 50% of the PACE-Life sessions vs. Fitbit Alone
| Midpoint | Posttest | Follow-up | ||||
|---|---|---|---|---|---|---|
|
| ||||||
| R2 base | ΔR2 int | R2 base | ΔR2 int | R2 base | ΔR2 int | |
| BPNS Autonomy | 0.080 | 0.013a | 0.079 | 0.095 b | 0.169 | 0.076 b |
| BPNS Relatedness | 0.349 | 0.001 | 0.364 | 0.000 | 0.603 | 0.001 |
| BPNS Competence | 0.427 | 0.117 c | 0.562 | 0.041 c | 0.469 | 0.031 c |
| BPNES Autonomy | 0.334 | 0.030 c | 0.401 | 0.025 b | 0.260 | 0.010 |
| BPNES Relatedness | 0.668 | 0.001 | 0.379 | 0.077 c | 0.742 | 0.004 |
| BPNES Competence | 0.398 | 0.125 c | 0.685 | 0.044 c | 0.753 | 0.014 |
| BREQ RAI | 0.601 | 0.033 b | 0.726 | 0.001 | 0.700 | 0.000 |
| Minutes Spent Walking | 0.051 | 0.003 | 0.466 | 0.019 | 0.558 | 0.001 |
| Steps/day | 0.516 | 0.055 b | 0.465 | 0.045 b | 0.098 | 0.001a |
| 6-minute walk test | 0.550 | 0.012 | 0.673 | 0.009 | 0.774 | 0.039 c |
Note. base = baseline; int = intervention; bold indicates ΔR2 ≥ .020.
ΔR2 ≥ .020 in full sample but not in completers
ΔR2 ≥ .020 in completers but not in full sample
ΔR2 ≥ .020 in both full sample and completers
Discussion
This study was a pilot RCT that evaluated a virtual theory-based multicomponent group-based walking program, Virtual PACE-Life, against a Fitbit Alone condition in a sample of 37 adults with schizophrenia. To our knowledge, this is the first RCT of a live, video-delivered exercise program for adults with schizophrenia. Intent-to-treat analyses revealed minimal group differences between interventions in terms of proximal or primary outcomes and a low percentage of participants experienced clinically meaningful changes in these outcomes. There were some differences, however, in terms of improvements in competence and autonomy satisfaction favoring Virtual PACE-Life. Post-hoc completer analyses indicated improvements in steps/day and autonomous motivation for participants attending at least half of the Virtual PACE-Life sessions. Overall, results from intent-to-treat and completer analyses in this RCT suggest that Virtual PACE-Life has some impact on SDT needs, autonomous motivation, and steps/day but minimal effects on CRF.
Intent-to-treat analyses revealed group differences in SDT need satisfaction for competence and autonomy that favored Virtual PACE-Life. Compared to participants randomized to Fitbit Alone, participants in Virtual PACE-Life had higher competence satisfaction at all timepoints and higher autonomy satisfaction at midpoint. These findings are encouraging given that specific components of PACE-Life were designed to target these SDT needs. Specifically, the activity tracking and goal-setting aspects targeted competence as participants were encouraged to set goals for steps/day and minutes spent walking and use their Fitbits to monitor these goals. It may be that consistently setting and achieving walking goals led participants to experience competence. Further, although Virtual PACE-Life offers recommendations for frequency and duration of home-based walking sessions, participants were encouraged to select their preferred location and time of day to complete these walks, thereby promoting autonomy. These results are in line with prior work that has identified goal-setting and self-efficacy as predictors of physical activity in persons with serious mental illness (Zechner & Gill, 2016). Completer analyses revealed consistent findings for competence satisfaction but different results for autonomy satisfaction. Specifically, Fitbit Alone participants had greater autonomy satisfaction at post-test and follow-up compared to Virtual PACE-Life participants. These completer results may illustrate that solely having access to an activity tracking device (i.e., Fitbit) without any additional support promotes greater autonomy than using this aspect within the context of a larger walking program.
Virtual PACE-Life did not impact relatedness despite the group-based walking sessions and ironically, relatedness satisfaction was greater for participants in Fitbit Alone (which did not have a group-based aspect) at posttest compared to those in Virtual PACE-Life. It is possible that the virtual platform made consistent interaction among participants difficult during Virtual PACE-Life walking sessions, thereby reducing the impact on relatedness satisfaction. In fact, facilitating adequate social interaction among persons with schizophrenia during groups has been cited as a challenge when adapting established treatments to virtual platforms (Mendelson et al., 2022). Finally, there were no differences in autonomous motivation between the two groups in intent-to-treat analyses, but completer analyses revealed greater autonomous motivation at midpoint favoring Virtual PACE-Life. Although it seems that participants experienced some initial increase in autonomous motivation from Virtual PACE-Life, no differences between groups were observed at post-test or follow-up. These results are largely consistent with a recent meta-analysis that showed that it is extremely difficult to increase autonomous motivation for physical activity; out of 35 trials, only 10 (29%) succeeded in doing so (Sheeran et al., 2021).
Intent-to-treat analyses showed no group differences in proximal outcomes (steps/day, minutes spent walking) at midpoint or posttest and only a small percentage of participants experienced clinically meaningful increases in steps/day during the study. Completer analyses revealed greater steps/day at midpoint and post-test for the Virtual PACE-Life group but were not maintained at follow-up. Though the increase in steps/day for completers was likely a product of higher attendance at group-based walking sessions, this finding is important given that any increase in physical activity is beneficial (Bull et al., 2020). As the current trial was conducted virtually during the COVID-19 pandemic, it may be that factors unrelated to the intervention made increasing and maintaining physical activity difficult for many participants. In fact, a systematic review of 15 studies found that psychological distress increased and physical activity levels decreased during the pandemic (Violant-Holz et al., 2020), suggesting that the findings in our study may be reflective of a broader population-based pattern. Further, anxiety and depressive symptoms increased in persons with schizophrenia during COVID-19 (Biviá-Roig et al., 2022) and rates of loneliness and social isolation were elevated (Heron et al., 2022), all of which can deleteriously impact motivation and exercise levels. In addition, as persons with schizophrenia are often medically compromised and at risk for complications from COVID-19 (Kozloff et al., 2020), many participants may not have felt safe to leave their homes often, which would have reduced the opportunities for increasing activity. Just over one third of participants (41% in Virtual PACE-Life, 35% in Fitbit Alone) were able to meet the clinically meaningful threshold of 150 min/week of walking during any of the final six weeks of the study. As such, it may be that, overall, participants were more able to identify opportunities to complete time-limited walking sessions rather than increasing their total accumulation of steps/day. This finding is encouraging given the associations between meeting this threshold and reduced likelihood of cardiovascular mortality (Kraus et al., 2019).
There were no group differences in CRF at midpoint or posttest nor did many participants experience clinically meaningful increases over the course of the study, which contrasts with the positive findings reported in earlier open trials of PACE-Life delivered in person (Browne et al., 2021; Orleans-Pobee et al., 2021) and of an in-person walking program for veterans with schizophrenia (Kern et al., 2020). The absence of CRF improvements may be attributable to the limited increases in overall exercise behavior; however, attendance at groups was above 50%, a rate higher than the 34% observed in the open trial (Browne et al., 2021). Further, completer analyses revealed higher steps/day for Virtual PACE-Life participants who attended at least 50% of groups. As such, these findings likely suggest that a sufficient dose-response was not achieved during group-based virtual walking sessions to impact CRF, although all attempts were made to increase the volume and intensity of exercise throughout the study. When delivered in person, participants can modify their walking routes to include elevation and/or to increase their speed easily to increase the intensity of the exercise. Virtually, participants were on flat ground, indoors, and encouraged to follow the movements provided by instructors. As such, it may be that the virtual intervention did not allow for increasing intensity as readily, very likely impacting the expected potential for improving CRF.
The study had two central limitations. First, there was missing primary outcome data (6MWT) due to participants’ preference to complete assessments virtually due to safety concerns regarding COVID-19. Because data from these participants were missing at all timepoints (including baseline), multiple imputation was not used. As such, results may have been biased by low completion rates and characteristics of participants that were willing to attend in-person assessments. Second, the sample size was small to test longitudinal trajectories of change or baseline-by-treatment interactions, which reduced power and may have obscured potential group differences. Based on these limitations and the overall null findings of this study, follow-up work should be done to evaluate qualitative feedback from participants in this trial to understand their experience of the virtual intervention and any recommendations for future changes. Additionally, future analyses should consider evaluating predictors of engagement and exercise increases, particularly negative symptoms, to inform modifications to the intervention. Finally, future studies should draw upon promising virtual exercise programs developed for older adults during the COVID-19 pandemic (Jennings et al., 2020; Schwartz et al., 2021) to refine Virtual PACE-Life and ultimately deliver an effective and accessible virtual walking intervention to persons with schizophrenia.
Supplementary Material
Highlights.
Virtual PACE-Life is a motivational theory-based live, video-delivered multicomponent walking intervention for persons with schizophrenia
Attendance at Virtual PACE-Life was 58%, which is higher than a prior study of the in-person version of PACE-Life
Virtual PACE-Life participants had greater satisfaction of competence and autonomy needs than participants in Fitbit Alone
Participants who attended at least 50% of Virtual PACE-Life sessions had greater improvements in objectively-measured physical activity (steps/day) compared to participants in Fitbit Alone
Virtual PACE-Life was not associated with improvements in six-minute walk test-measured cardiorespiratory fitness
Acknowledgements:
We would like to thank all the participants who were involved in the PACE-Life study. Additionally, we appreciate the support from Claudia Driver, Shannon Wallace, Dr. Rupal Yu and the Schizophrenia Treatment and Evaluation Program (STEP), Outreach and Support Intervention Services (OASIS), and Encompass clinics. We are grateful to our research staff: Aslihan Imamoglu, Kyle Ross, and Elena Pokowitz as well as our group leaders: Anna Geib, Hillary Little, Gabrielle Lowenthal, Carrington Merritt, Jennifer Niles, Princess Oates, Bryan Stiles, and Camila Vallebona for their incredible work on this project. The lead author certifies the accuracy of the results and interpretation of the findings.
Funding:
This study was funded by the National Institute of Mental Health (R34MH111852) to MPIs: Dr. David L. Penn and Dr. Claudio Battaglini. This study was registered on clinicaltrials.gov (NCT04173572). Dr. Browne is supported by a VA Rehabilitation Research and Development Career Development Award (IK1RX003904). The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the United States Government or Department of Veterans Affairs.
Footnotes
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The first participant of the in-person PACE-Life randomized trial enrolled in January 2020. A total of 13 participants were randomized in this first cohort (seven in PACE-Life, six in Fitbit Alone). The trial was halted in March 2020 at the start of the COVID-19 pandemic. At that point, all in-person group activities were halted following university and state policies. Seven group sessions had occurred at the time when study activities were halted. Post-treatment assessments were completed immediately through virtual modality. Virtual follow-up assessments were completed one month following post-treatment. Completion of post-treatment and follow-up assessments were 70% or above (PACE-Life: 100% post-treatment, 71.4% follow-up; Fitbit Alone: 66.7% post-treatment, 83.3% follow-up. The final participant received their follow-up assessment in June 2020. Due to the small sample size and truncated exposure to PACE-Life, the data for this cohort was not analyzed and included in this manuscript.
Conflicts of Interest
The authors declare no conflicts of interest relevant to the subject of this article. Given her role as Co-Editor-in-Chief for MENPA, Dr. Abrantes had no involvement in the peer-review of this article and no access to information regarding its peer review.
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