Supportive Training After Cardiac Rehabilitation Including Virtual Engagement

Not Applicable

Not yet recruiting

• Conditions: Cardiac Rehabilitation

• 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

Not available

Study Timeline

• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-20
• Study First Posted: 2024-11-22
• Status Verified: 2025-05
• Study Start: 2025-05-13
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-15
• Primary Completion: 2029-03-31
• Study Completion: 2029-06-30

Recruitment & Eligibility

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

Inclusion Criteria

1. ≥ 60 years of age
2. History of CVD that qualified patient for Phase II CR (MI, percutaneous coronary intervention, coronary artery bypass grafting, heart failure, valve replacement, etc.)
3. Adherence to CR ( ≥ 50% sessions for ≥ 1 month)

Exclusion Criteria

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

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

3. Lack of English or Spanish proficiency/literacy

4. Unstable clinical conditions

   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, New York Heart Association (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
Adherence to Physical Activity	12 months	Daily step counts

Secondary Outcome Measures

Name	Time	Method
Depression/loneliness	12 months	Self-reported using: 8-item Patient Health Questionnaire (score 0-24, higher scores indicate greater severity of depressive symptoms; generally, a score of 10 or higher is considered clinically significant for major depression); PROMIS Social Isolation Short Form 4a survey (raw score 4-20, scale score 34.8-74.2, higher score indicates greater social isolation)
Self-efficacy/social support	12 months	Self-reported using: 9-item Self-efficacy for Exercise (score 9-28, a higher score indicates higher self-efficacy for exercise); 12-item Multidimensional Scale of Perceived Social Support (score 12-84, lower score means lower perceived social support)
CVD risk factors	18 months	BMI

Trial Locations

Locations (1)

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