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. Author manuscript; available in PMC: 2025 Jul 31.
Published in final edited form as: Neurorehabil Neural Repair. 2025 Jul 10;39(10):779–788. doi: 10.1177/15459683251352493

Maintenance of Improvements in Walking Activity in Individuals with Chronic Stroke: Follow-Up From the PROWALKS Randomized Controlled Trial

Elizabeth D Thompson 1,*, Kiersten M McCartney 1,2,*, Ryan T Pohlig 3, T George Hornby 4, Scott E Kasner 5, Jonathan Raser-Schramm 6, Christopher E Henderson 4, Henry Wright 1, Tamara Wright 1, Darcy S Reisman 1,2
PMCID: PMC12313201  NIHMSID: NIHMS2088977  PMID: 40637166

Abstract

Background.

Individuals with chronic stroke are less active, which is both a consequence of stroke-related impairments and a risk factor for future health complications. The PROWALKS clinical trial found significant gains in real-world walking activity (steps/day) after 12 weeks of a step activity monitoring behavioral intervention, provided either alone (SAM) or with high-intensity gait training (FAST + SAM), but not after high-intensity gait training alone (FAST). Previous research in individuals after stroke suggests that tailored behavioral counseling may lead to better long-term physical activity participation, but no previous work has focused on post-intervention maintenance of walking activity changes.

Objective.

To investigate whether steps/day changes after training (POST) were maintained at 6 months (6MO) and 12 months (12MO) after baseline. We hypothesized that SAM and FAST + SAM groups would have better maintenance of steps/day changes than the FAST group.

Methods.

This analysis included all participants who completed the PROWALKS intervention (n = 200, mean[SD] age: 63.27[12.41], 102 male/98 female, >6 months post-stroke). Analysis outcomes were steps/day change from POST-6MO, and from POST-12MO.

Results.

All groups significantly decreased in steps/day from POST-6MO (P = .001, FAST decreased by mean[SE] 160[272], SAM by 1016[270], FAST + SAM by 400[300]), and POST-12MO (P < .001, FAST decreased by 610[280], SAM by 1072[306], FAST + SAM by 568[313]). There were no significant differences between groups.

Conclusions.

All intervention groups showed significant declines in steps/day between POST and 6MO and between POST and 12MO. These results add to a growing body of literature suggesting that a behavioral intervention to initiate behavior change may not be sufficient for maintenance of change.

Registration:

This study is registered at ClinicalTrials.gov, NCT02835313.

Keywords: walking, stroke, high-intensity gait, step activity monitoring, maintenance

Introduction

After a stroke, individuals are often less physically active1–5 for many reasons, including deconditioning, fatigue, pain, and decreased independence with their mobility.4–7 Inactivity leads to increased risk of diabetes, myocardial infarction, another stroke, or even death.1,3–5,8 Insidiously, these additional health concerns can lead to further deconditioning,2,5,7,8 creating a vicious cycle of inactivity, disability, and severe health risks. Increasing physical activity through walking is a highly important goal for individuals after a stroke,9 and is also associated with decreases in blood pressure, body weight, and risk of diabetes and cardiovascular disease for people with chronic cardiovascular conditions.10,11 Given this, improved walking presents both a salient and clinically impactful target for increasing physical activity.

The World’s Health Organization’s International Classification of Functioning, Disability and Health (ICF) framework characterizes walking within its Activity domain. Activity can be defined as capacity (“what an individual can do under standardized conditions, such as in a clinic or laboratory”) or performance (“what an individual does in their unstructured everyday environment”).12 In studies of individuals after a stroke, high-intensity gait training has led to improved walking capacity (gait speed, endurance).13,14 However, increased capacity does not consistently carry over to increased walking performance (steps per day in a person’s natural environment), these interventions often lead to modest increases15 or no increases16–18 in walking performance.19–21

The Promoting Recovery Optimization with WALKing Exercise After Stroke (PROWALKS) clinical trial compared a high-intensity walking intervention (FAST), a step activity monitoring behavior intervention (SAM), and a combination intervention of both programs (FAST + SAM) to address walking performance in individuals with chronic stroke (≥6 months post-stroke) (Figure 1). The study protocol and primary results have been previously published.22,23 The primary analysis of the PROWALKS data identified that a step activity monitoring behavioral intervention can lead to significant gains in daily walking performance in people with chronic stroke. This finding was an important step forward in our understanding of how to improve walking activity after stroke.22 However, it is unknown how well this type of performance change can be maintained after a walking activity intervention ends.

Figure 1.

Figure 1.

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CONSORT diagram (POST=post-intervention testing; 6MO=6-month follow-up; 12MO=12-month follow-up; CPET=cardiopulmonary exercise test.)

Previous studies of aerobic and resistance exercise programs post-stroke have found that once the intervention concludes, improvements are not sustained.3,24 Similar effects have been seen across other populations in exercise and behavioral interventions for physical activity—once the intervention aimed at increasing activity is removed, gains made during the treatment are not sustained.6,25–27

One behavioral approach based on sound behavioral theory that may increase long-term adherence to healthy lifestyle changes, including physical activity, is individually-tailored counseling based on sound behavioral theory.25,26,28 Such individually-tailored counseling was included in the PROWALKS step activity monitoring behavioral intervention. Prior to PROWALKS, this behavioral approach had only been applied on a small scale with mixed results in individuals after stroke.29 Furthermore, its effects, when paired with step monitoring and goal setting—additional key components of step activity behavior change interventions—have not been evaluated after stroke.29

This planned secondary analysis investigated whether the steps/day changes observed after the PROWALKS interventions were maintained at 6 months and 12 months after baseline. We hypothesized that the 2 groups who received the step activity monitoring behavioral intervention (SAM and FAST + SAM) would have better maintenance of their walking performance between the end of the intervention and the 2 follow-up time points than the group receiving high-intensity training alone (FAST). Better maintenance of walking performance was defined as less decline in steps/day between post-intervention and 6 months after baseline, and between post-intervention and 12 months after baseline.

Methods

Study Design

The PROWALKS study was a multi-site, assessor-blinded randomized controlled trial. Participants were enrolled between July 2016 and November 2021 at 4 university/hospital-based physical therapy laboratories. Briefly, participants underwent a pre-intervention baseline assessment (PRE) conducted prior to randomization, a post-intervention assessment (POST) after the 12-week training period, and follow-up assessments at 6 months and 12 months after baseline (6MO and 12MO, respectively). The trial conformed to the Declaration of Helsinki, is reported according to CONSORT guidelines, and was approved by all sites’ institutional review boards (main site approval #878153). Additional PROWALKS methodology can be found in the Supplement. De-identified data and relevant documents are available via the NICHD DASH repository (https://dash.nichd.nih.gov/) upon reasonable request approved by the repository.

Participants

Participants were recruited for PROWALKS from the community through clinicians and support groups, advertisement, existing databases, and health record systems. Participants provided written informed consent, and all met the following inclusion criteria: (1) age 21–85 years, (2) at least 6 months post-stroke, (3) able to walk without assistance of another person (assistive devices and orthotics were permitted), (4) self-selected walking speeds between 0.3 m/s and 1.0 m/s, (5) average steps/day <8000, (6) resting heart rate (HR) 40–100 beats per minute, and (7) resting blood pressure (BP): systolic 90–170, diastolic 60–90 mmHg. Exclusion criteria included: (1) evidence of cerebellar stroke, (2) other neurological deficits unrelated to stroke, (3) lower limb botulinum toxin injection ≤4 months previous, (4) currently in physical therapy, (5) unable to walk outside the home prior to stroke, (6) coronary artery bypass graft, stent placement, or myocardial infarction ≤3 months previously, (7) inability to communicate with investigators, and (8) score >1 on question 1b and >0 on question 1c on the NIH Stroke Scale (indicating the individual was not oriented and/or could not follow simple commands) (see Figure 1).23 The gait speed lower limit of 0.3 m/s was established shortly after the start of the study, due to challenges with the accuracy of Fitbit™ devices when gait speed was slower than 0.3 m/s.30 See Figure 1 for CONSORT diagram.

Outcome Assessments

Blinded assessor physical therapists measured study outcomes at each of the 4 time points (PRE, POST, 6MO, and 12MO). Steps/day were assessed following each clinical evaluation via Fitbit wearable devices (see Supplement). The outcome of interest in the present analysis was the maintenance of any walking performance changes observed following the intervention period. This was quantified as the change in steps/day at the 6MO and 12MO time points compared with POST.

Interventions

After enrollment and PRE testing, 250 participants were randomized to one of the following groups (See Figure 1)22: high intensity walking training (FAST), step activity monitoring behavioral intervention (SAM), or a combined program including both high intensity walking training and step activity monitoring behavioral intervention (FAST + SAM). Participants were assigned using a random allocation sequence and concealed allocation. The allocation sequence was generated by the study coordinator using https://www.randomizer.org. Group assignments were kept in sequentially numbered sealed opaque envelopes opened by the study coordinator and communicated directly to the training physical therapist. The study coordinator did not have any involvement in training, assessments, or data analysis. The biostatistician (RP) was blinded until the primary analysis of study outcomes was completed.

During the training intervention, the attendance goal for all groups was up to 36 sessions (~3×/week for 12 weeks). Participants receiving FAST training (FAST and FAST + SAM) completed up to 30 minutes of treadmill walking followed by 10 minutes of overground activities at each session, while maximizing time within their Target Heart Rate (THR) range (70–80% heart rate reserve).22,23 SAM training sessions (SAM and FAST + SAM) included discussions of individualized goal-setting for steps/day and coaching to improve daily walking activity.22,23 Those in the FAST+ SAM group received both FAST and SAM training at each session (See previous publications22,23 and Supplement for more information on the interventions.).

Statistical Analyses

Trial sample size, power, and statistical plan were published in the trial protocol paper23 and with the results of the primary endpoint (PRE-POST comparisons).22 The present analysis focused on the separate question of maintenance of steps/day from POST through 12MO. Analysis began with the POST time point and used an intent-to-treat approach for participants from POST through 12MO.

Marginal General Linear Mixed Models were used as planned for the primary outcome of steps/day.22,23 Fixed effects included the main effects of group and time, along with their interaction, a compound symmetric covariance matrix for the errors was used to account for the repeated measures. This was chosen by finding the best fitting covariance matrix as determined by examining the Akaike information criterion (AIC) and Bayesian information criterion (BIC). The Satterthwaite approximation was used for determining degrees of freedom. The models used robust errors (Hubert-White) to account for mild departures of normality. Maximum likelihood estimation was employed to garner estimates in the presence of missing data without needing listwise deletion.

Several additional tests were performed to better understand the steps/day results at the follow-up time points in the context of participant’s baseline data. Non-parametric within-group Wilxocon signed rank tests (due to differences in sample size at different time points) compared steps/day at baseline versus 12MO. Additionally, 2 sequential linear regression models were used to detect possible relationships between demographic/baseline clinical performance measures and steps/day at follow-up time points. One model tested steps/day at 6MO as the outcome variable, while the other model tested steps/day at 12MO as the outcome.

Analyses were performed to determine possible differences in demographic variables and baseline clinical performance measures between those with missing data at 12MO and those with complete data, as well as possible between-groups differences in these variables among those with missing data at 12MO.

Results

Participants

Figure 1 presents information regarding the number of participants from screening to 12-month testing. All participants who remained in the study at POST were included in the current analysis. The participants at POST had a mean [SD] age of 63.27 [12.41] years and were an average of 47.23 [65.53] months post-stroke. (See Tables 1 and 2 for further demographic and clinical performance information.)

Table 1.

Participant demographic characteristics at study baseline (either by mean (SD) or N (%)).

FAST (n=69) SAM (n=68) FAST+SAM (n=63)
Age, years 63.57 (11.31) 63.07 (12.52) 63.16 (13.58)
Time since stroke, months 51.25 (65.20) 47.84 (78.28) 42.16 (49.56)
Body mass index (kg/m2) 29.59 (6.24) 32.32 (7.01) 29.48 (5.13)
Females, N (%) 35 (50.72%) 35 (51.47%) 28 (44.44%)
Race, N (%)
  Native American/Alaskan native 3 (4.35%) 3 (4.41%) 2 (3.17%)
  Asian 6 (8.70%) 1 (1.47%) 4 (6.35%)
  Native Hawaiian/Pacific islander 0 0 0
  Black/African-American 17 (24.64%) 23 (33.82%) 18 (28.57%)
  White 45 (65.22%) 44 (64.71%) 42 (66.67%)
  Multiple races 3 (4.35%) 3 (4.41%) 5 (7.94%)
  Prefer not to identify race 1 (1.45%) 0 0
Hispanic/Latinx ethnicity, N (%) 5 (7.25%) 2 (2.94%) 2 (3.17%)
Side of hemiparesis, N (%)
  Left 37 (53.62%) 34 (50.00%) 29 (46.03%)
  Right 30 (43.48%) 30 (44.12%) 30 (47.62%)
  Neither/both affected 2 (2.90%) 4 (5.88%) 4 (6.35%)
Assistive device use, N (%) 36 (52.17%) 37 (54.41%) 30 (47.62%)
Orthotic device use, N (%) 19 (27.54%) 20 (29.41%) 19 (30.16%)
Beta blocker use, N (%) 27 (39.13%) 32 (47.06%) 25 (39.68%)
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Table 2.

Participant clinical characteristics at post-intervention (mean (SE)).

FAST (n=69) SAM (n=68) FAST+SAM (n=63)
Self-selected gait speed, m/s 0.85 (0.03) 0.82 (0.03) 0.82 (0.04)
6-minute walk test distance, m 340 (14) 316 (14) 321 (16)
Steps per day 4327 (324) 5496 (326) 4870 (353)
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Outcomes

There was a significant effect of time between POST and 6MO (P = 0.001, 95% CI [decrease of 206–844]), and between POST and 12MO (P < .001 [decrease of 409–1,092]) for steps/day. There was no significant group-by-time interaction (p = 0.26). From POST to 6MO, all groups decreased their steps/day, FAST by (mean [95% CI]) 160 [−376 to −697], SAM by 1016 [485–1546], and FAST + SAM by 400 [−190 to −990]. From POST to 12MO, all groups decreased their steps/day, FAST by 610 [59–1162], SAM by 1072 [469–1675], and FAST + SAM by 568 [−48 to −1185] (see Table 3 and Figure 2).

Table 3.

Outcome changes between post-intervention, 6 months, and 12 months (mean (SE) [95% CI for change]). Primary outcome=steps/day; (Abbreviations: SE=standard error; CI=confidence interval; POST=post-intervention testing; 6mo=6-month follow-up; 12mo=12-month follow-up.)

Outcomes FAST SAM FAST+SAM
Steps per day
  POST 4327 (324) 5496 (326) 4870 (353)
  6mo 4167 (329) 4480 (315) 4470 (335)
  12mo 3717 (285) 4424 (347) 4302 (347)
  Change from POST to 6mo −160 (272) −1,016 (270) −400 (300)
  CI [−697 – 376] [−1546 – −485] [−990 – 190]
  Change from POST to 12mo −610 (280) −1,072 (306) −568 (313)
  CI [−1162 – −59] [−1675 – −469] [−1185 – 48]
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Figure 2.

Figure 2.

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Primary outcome: changes in steps/day by treatment group between POST and 6-month follow-up, and between POST and 12-month follow-up. Error bars denote standard error. (6MO=6-month follow-up; 12MO=12-month follow-up; F+S=FAST+SAM group.) a) Steps/day mean values by group. b) Magnitude of steps/day change for each group between POST and each of the two follow-up points (6MO and 12MO). Dots indicate mean, violin plots indicate individual results.

Chi-square analysis and independent t-tests revealed no significant differences in demographic variables and baseline clinical performance measures between those with missing versus complete 12MO data in sex, side of hemiparesis, use of assistive device or lower extremity orthotic, race, ethnicity, age, stroke chronicity, body mass index (BMI), steps/day, 6-Minute Walk Test (6MWT) distance, or self-selected walking speed (SSWS). Two-way ANOVA analyses revealed no significant between-group differences in these same demographic variables and clinical performance measures in those with missing versus complete 12MO data. Sequential linear regression models revealed that none of the variables included (sex, age, time since stroke, baseline SSWS, baseline 6MWT distance, or baseline steps/day) were significant predictors of steps/day at 6MO or steps/day at 12MO.

At the 12MO time point, steps/day were greater than at baseline in both the SAM (increase of mean [95% CI] 412 [−122 to 947]) and FAST + SAM groups (increase of 728 [233–1223]), and less than at baseline in the FAST group (decrease of 201 [−248 to 650]). This difference was significant in the FAST + SAM group (P = 0.02).

There were no serious study-related AEs between POST and 12MO (please see Supplement, Table S1B, for full adverse event incidence).

Discussion

The purpose of this planned secondary analysis was to investigate whether the steps/day changes observed after the PROWALKS interventions were maintained at 6 and 12 months after baseline. We hypothesized that there would be sustained benefits specifically in the groups that received the step activity monitoring behavioral intervention. This hypothesis was based on evidence suggesting that, contrary to the results seen after many types of exercise interventions, adding individually-tailored counseling based on sound behavioral theory may enhance maintenance of physical activity improvements.25,28,29,31–33

However, this hypothesis was not supported. The results demonstrate that, regardless of intervention group, there was a significant decline in steps/day from POST to 6MO and from POST to 12MO. These results suggest that even after significant initial gains in step activity following a step activity monitoring behavioral intervention, maintaining these intervention gains in walking activity is a challenge.

As has been observed in other populations, it is possible that our participants’ particular health histories may have decreased the likelihood of them maintaining activity changes. As a group, those with chronic stroke are more likely to experience mobility impairments, cardiovascular conditions, medical comorbidities, and depressive symptoms than their age-matched peers who haven’t had a stroke.34–36 Previous work in other populations has found that each of these conditions independently decreases the likelihood of an individual maintaining a health-related behavior change.25,31 It is possible that the constellation of impairments in our cohort made it more difficult (and ultimately less likely) for them to maintain the steps/day gains they showed immediately post-intervention. The differences between this present work and previous health-related behavior change studies in other populations illustrate the importance of understanding the specifics of behavior change and maintenance in those with chronic stroke. This is a growing population5 where inactivity greatly increases the risk for further devastating medical complications.4,5,37,38

Another possible reason for our findings is the nature of the relationship between behavior change and behavior maintenance. While combining the study of behavior maintenance with initial behavior change is common in the physical activity literature, the broader field of health behavior research has long recognized that this relationship is complex.25,39–41 As Rothman eloquently stated in 2000: “. . .the decision criteria that lead people to initiate a change in their behavior are different from those that lead them to maintain that behavior Because maintenance has been operationalized as action sustained over time, it is predicted to rely on the same set of behavioral skills and motivational concerns that facilitate the initial change in behavior. Yet, this perspective is at odds with the repeated finding that those who successfully initiate a change in their behavioral practices frequently fail to maintain that pattern of behavior.”39

The individually-tailored counseling that was included as part of the PROWALKS step activity monitoring behavioral intervention shares many characteristics with techniques that are well-supported in the behavior change literature, such as focusing on the positive life impact to be experienced after the behavior change,25,28,39,42,43 highlighting the discrepancy between the present behavior state and the desired behavior state,28,39,42,43 and problem-solving potential barriers to behavior change.25,31,42,43 However, as Rothman stated and other studies have echoed, maintaining change is more complex than simply continuing to repeat the processes that led to the initial change.28,39,43,44 Though far less studied than behavior change itself, maintenance of a health behavior has been found to be associated with factors such as satisfaction with the new behavior,28,39,43 confidence to consistently perform the behavior even with occasional lapses,28,39,43,44 and development of a personal identity related to performing the behavior.28,42 Thus, it is possible that the behavioral intervention we utilized, which focused on initiating a behavior change, did not adequately account for differences between behavior change initiation versus maintenance.28,39,43

While the gains in daily step activity that were achieved by the 2 groups receiving the step activity monitoring behavioral intervention (SAM and FAST + SAM) were not maintained, it is important to note that several key features of the behavioral intervention have been shown to be beneficial in both initiating and maintaining behavior change. For example, while self-monitoring is an important element to overcoming barriers and accurately assessing progress during behavior change,25,45 self-monitoring also demonstrates an individual’s internal motivation, strongly related to maintaining behavior change.43 Providing feedback was a central focus of the PROWALKS behavioral intervention which is associated with successful health-related behavior change,25,31,46 and feedback can also be an important element of behavioral maintenance.28 Finally, increased self-efficacy has been observed in motivational-interviewing based interventions,47 and is related to success both in behavior change25,48 and maintaining a new behavior.43 Future research is required to better understand what key ingredients of a step activity monitoring behavioral intervention are needed to maintain changes in daily walking activity in people with chronic stroke. Furthermore, when to incorporate these maintenance ingredients into an intervention must be investigated.

There were limitations to the current analysis, most notably attrition over the follow-up period. However, post-hoc analysis revealed no significant differences between those with missing data at 12MO and those with complete data in demographic and baseline clinical variables, or between-group differences among those with missing data at 12MO. Additionally, many individuals’ study participation coincided with the COVID-19 pandemic, and we do not know the possible impact this may have had on their walking activity during the study follow-up period (from POST to 12MO). Finally, it is unclear how well the results might generalize to people with chronic stroke who walk slower than 0.3 m/s or who require physical assistance from another person to walk.

Conclusions/Implications

We found significant declines in steps/day across all 3 treatment groups between POST and 6MO, and again between POST and 12MO. The challenge of behavior change maintenance in our results mirrors what has been seen in studies focused on changing health risks through behaviors such as weight loss, cardiovascular risk reduction, and aerobic training after stroke. Our results add to a growing body of literature suggesting that perhaps ingredients of a behavioral intervention that address behavior change initiation may not be sufficient for maintenance of those changes. Future research should explore what ingredients of a step activity monitoring behavioral intervention are needed for people with stroke to maintain step activity improvements after the end of the intervention.

Supplementary Material

Supplementary_1
Supplementary_2

Supplementary material for this article is available on the Neurorehabilitation & Neural Repair website along with the online version of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the National Institutes of Health [NIH R01 HD086362-01A1] (DSR).

Declaration of Conflicting Interests

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr. Hornby is the co-owner for the Institute for Knowledge Translation.

Dr. Kasner reports grants from Bayer, Medtronic, consulting fees from Bristol-Myers Squibb, DiaMedica, Medtronic, WL Gore, and royalties from UpToDate.

Dr. Henderson is partially employed by the Institute for Knowledge Translation.

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