|
Baseline & screening
|
Demographic and clinical variables Tool
|
Demographic (e.g., race, gender, age, marital status) |
Clinical data (e.g., ejection fraction or EF, medications, BMI, comorbidities) |
Cardiopulmonary stress test
|
Determine suitability for exercise (no significant ischemia or arrhythmias) |
Heart rate ranges and appropriate levels of exercise training |
|
Primary outcome – Aim 1 (Baseline, 6, 12 and 18 months)
|
Adherence
|
|
Self-report
|
Exercise diary for self-report of sessions per week and minutes per session [56] |
Heart rate monitor
|
Heart rate monitor (used as validation of self-reported exercise each week |
|
Evaluation of intervention mechanisms – Aim 2 (Baseline, 6, 12 and 18 months)
|
Knowledge
|
Physical activity & heart disease I.Q. – developed by NHLBI [57] 12 true/false items testing knowledge of how physical activity affects the heart |
Attitudes
|
Attitudes toward physical activity/exercise - 8 items measure negative attitudes toward physical activity and 6 items measure positive attitudes toward physical activity [58] |
Self-efficacy
|
Barriers Self-Efficacy Scale (BARSE) – 13 item scale measures self-efficacy or confidence in exercise behavior [59]; |
Self-management
|
Physical Activity Self-Regulation Scale (PASR 12)
|
Self-monitoring (2 items), Goal setting (2 items), Eliciting social support (2 items), Reinforcements (2 items), Time management (2 items) and Relapse management (2 items) [60] |
Social support
|
Revenson Support Scale
|
Problematic support (4 items) and Positive support (16 items) [61] |
|
Health outcomes – Aim 3 (Baseline, 6, 12 and 18 months)
|
Physical function
|
6 Minute Walk Test (6 MWT) – Objective measure of functional capacity (sub-maximal). Distance walked in 6 minutes [62, 63] |
Psychological function
|
PROMIS-29 Profile v1.0: Anxiety (4 item subscale), Depression (4 item subscale), Satisfaction with Social Role (4 item subscale) [64] |
Symptoms
|
Dyspnea/Fatigue Scale – Measures the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace at which the task is performed, and the associated functional impairment in general activities as a result of the symptoms [65] |
Quality of life
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) – 23-item disease-specific measure of quality of life in heart failure [66, 67] |
|
Qualitative data – Aim 5
|
Open-Ended questions
|
All subjects complete at baseline
|
All subjects at baseline
|
Survey prior experience with exercise, expectations related to exercise and outcomes from participation |
Open-ended comments on exercise diaries
|
All subjects complete each week of the study |
All subjects each week
|
What helped you to exercise this week? What made exercising a challenge this week? Other comments? |
One-on-one interviews
|
Open-ended questions with probing (30 minutes) |
with HC subjects
|
Interviews completed at 3, 6, 12 and 18 months |
Survey subjects’ perceptions of their experience with exercise adherence (e.g., challenges with adherence, helpful strategies, difficulties) |
One-on-one interviews with coaches
|
Open-ended questions with probing (every 6 months during active recruitment) |
Questions about perceptions of exercise adherence experiences, strategies/difficulties working with patients, assessments of intervention components, descriptions of the intervention process for each phase |
One-on-one interviews with group session leaders
|
Open-ended questions with probing (every 6 months during active recruitment) |
Questions about perceptions of exercise adherence experiences, strategies/difficulties working with patients, assessments of intervention components, descriptions of the intervention process |