Supportive Training After Cardiac Rehabilitation Including Virtual Engagement

Not Applicable

Recruiting

• Conditions: Adherence to Physical Activity After Completing Cardiac Rehabilitation (CR) in Older Adults

• Registration Number: NCT06701188
• Lead Sponsor: University of California, San Francisco

Brief Summary

The proposed research seeks to determine whether virtual coaching and social support focusing on key social cognitive factors will be an effective strategy for maintaining physical activity (PA) after completing cardiac rehabilitation (CR). Despite the well-documented benefits of CR, only 15-50% of individuals continue to exercise 6 months after completing CR.4-6 Thus, after 36 sessions (typically 12 weeks), many patients are left without the support necessary to sustain physical activity (PA) and prevent adverse secondary cardiac events. Though previous research has explored interventions to sustain PA after CR, many studies have been lacking in a theoretical basis, objective measurement of PA, measurement, and analysis of psychosocial and social cognitive factors, and long-term impact on clinical outcomes. Low-cost, pragmatic approaches to maintaining PA after CR is urgently needed for older adults, and virtual technologies offer promising solutions to promote adherence to PA. The three specific aims of the project are to: 1) determine the effect of virtual coaching and social support on adherence to PA (measured by objective step counts) in the intervention vs. control groups; secondary measures will be amount of sedentary time, functional fitness, and self-reported exercise; 2) determine the effect of virtual coaching and social support on psychosocial and social cognitive factors in the intervention vs. control groups; 2a) evaluate the extent to which psychosocial and social cognitive factors mediate the effect of the intervention on PA adherence; 3) examine differences in cardiovascular (CVD) risk factors (blood pressure, lipids, HbA1c, BMI) between groups.

Detailed Description

The investigators propose a randomized clinical trial in which the "STRIVE" control group will receive the Trainerize mobile app for (1) daily self monitoring of exercise, blood pressure, and weight; (2) education via weekly text messages; and (3) assigned monthly videos on various health topics. The "STRIVE +" intervention group will receive the same app for self-monitoring and education via text messages as the control group PLUS individually-tailored virtual coaching with goal-setting and social support/networking. Our specific aims are to:

Aim 1: Determine the effect of virtual coaching and social support on adherence to physical activity (PA; measured by objective step counts) in the intervention vs. control groups; secondary measures will be amount of sedentary time, functional fitness, and self-reported exercise.

Hypothesis 1: The intervention group will have more PA steps and self-reported exercise, less sedentary time, and higher functional fitness compared to the control group.

Aim 2: Determine the effect of virtual coaching and social support on psychosocial and social cognitive factors in the intervention vs. control groups.

Hypothesis 2: The intervention group will have lower depression/loneliness and higher self-efficacy/perceived social support compared to the control group.

Aim 2a: Evaluate the extent to which psychosocial and social cognitive factors mediate the effect of the intervention on PA adherence. Hypothesis 3: Lower depression/loneliness and higher perceived social support will mediate the effect of the intervention on PA adherence.

Aim 3: Examine differences in CVD risk factors (blood pressure, lipids, HbA1c, BMI) between groups. H: The intervention group will have better control of risk factors at 6, 12, and 18 months compared to control.

Study Timeline

• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-20
• Study First Posted: 2024-11-22
• Study Start: 2025-05-13
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-24
• Last Update Posted: 2025-07-29
• Primary Completion: 2029-03-31
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

1. ≥ 55 years of age
2. History of CVD that qualified patient for CR (myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, heart failure, valve replacement, etc.)
3. Adherence (>50% of sessions for ≥1 month) to outpatient Phase II CR and pending completion

Exclusion Criteria

1. Participation in Phase III CR (optional extended CR after outpatient Phase II CR for those who pay out-of-pocket)

2. Cognitive impairment (per Mini-Cog assessment tool with score 0-2)

3. Lack of English or Spanish proficiency/literacy

4. Clinical conditions including:

   1. Unstable arrhythmias, aortic stenosis, thrombophlebitis, dissecting aneurysm or symptomatic anemia
   2. Active infection
   3. Uncontrolled hypertension: resting systolic >180 mmHg, diastolic >100 mmHg
   4. Decompensated heart failure, NYHA Class III-IV
   5. Current unstable angina
   6. 2nd or 3rd degree heart block or exercise induced arrhythmias

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Step counts	At baseline, 3, and 6 months	The primary outcome of step counts will be collected from the Fitbit. Baseline measurements will be compared to repeated measures over time. Patients will wear the Fitbit for the 1-week run-in period before randomization then will wear it for 2 weeks at the end of month 3 and again at the end of month 6.

Secondary Outcome Measures

Name	Time	Method
Physical Activity, barriers and sedentary time: Rapid Assessment of Physical Activity scale	Baseline, 3, 6, and 12 months	This 9-item questionnaire assesses self-reported physical activity (higher score indicates higher activity, scored 0-9)
Physical Activity, barriers and sedentary time: Exercise Barriers Scale	Baseline, 3, 6, and 12 months	This 14-item questionnaire assesses exercise barriers. (Higher score associated with more positive perceptions of exercise, scored 14-56)
Physical Activity, barriers and sedentary time: Self-reported sedentary time	Baseline, 3, 6, and 12 months	The modified 1-item International Physical Activity Questionnaire assesses self-reported sedentary time (minutes/hours per day)
Functional fitness tests: sit-to-stand	Baseline, 3, 6, and 12 months	Investigators will assess the functional fitness outcomes by performing the 1 min sit-to-stand test (number of times from sitting to standing and back again within 60 seconds)
Functional fitness tests: 2 minute step test	Baseline, 3, 6, and 12 months	Investigators will assess the functional fitness outcomes by performing the 2-minute step test (number of times knee raised to designated position within 2 minutes)
Functional fitness tests: dumbbell curl test	Baseline, 3, 6, and 12 months	We will assess the functional fitness outcomes by performing the dumbbell curl test (number of dumbbell curls within 30 seconds)
Psychosocial factors: Depression	Baseline, 3, 6, and 12 months	The 8-item Patient Health Questionnaire (PHQ-8) will be used to measure depressive symptoms (higher score associated worse depression, scored 0-24)
Psychosocial factors: Loneliness	Baseline, 3, 6, and 12 months	Social Isolation Short Form 4a survey (PROMIS) featuring 4 questions adapted from the 20-question UCLA Loneliness Scale (Higher score associated with greater feelings of loneliness/isolation, scored 4-20)
Social cognitive factors: Self-efficacy	Baseline, 3, 6, and 12 months	The 9-item Self-efficacy for Exercise scale uses components of Social Cognitive Theory (higher score associated higher self-efficacy, scored 0-90)
Social cognitive factors: Self-regulation	Baseline, 3, 6, and 12 months	The 12-item Physical Activity Self-Regulation scale (PASR-12) has 6 sub-scales including self-monitoring, goal-setting, eliciting social support, reinforcement, time management, and relapse prevention (higher score associated with higher self-regulation, scored 12-60)
Social cognitive factors: Perceived social support	Baseline, 3, 6, and 12 months	The 12-item Multidimensional Scale of Perceived Social Support includes 3 subscales: family, friends, and significant other (higher score associated with higher perceived social support, scored 12-84)
CV risk factors: hyperlipidemia	Baseline, 3, 6, 12, and 18 months	Lipids assessed from blood test results from the electronic medical record (EMR)
CV risk factors: hypertension	Baseline, 3, 6, 12, and 18 months	Hypertension assessed from blood pressure results from the electronic medical record (EMR)
CV risk factors: diabetes	Baseline, 3, 6, 12, and 18 months	Hemoglobin A1c assessed from blood test results from the electronic medical record (EMR)
CV risk factors: obesity	Baseline, 3, 6, 12, and 18 months	BMI assessed from the electronic medical record (EMR)

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States