Supportive Training After Cardiac Rehabilitation Including Virtual Engagement (STRIVE)

Supportive Training After Cardiac Rehabilitation Including Virtual Engagement: The STRIVE Study

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.

Study Overview

• Status: Recruiting
• Conditions: Adherence to Physical Activity After Completing Cardiac Rehabilitation (CR) in Older Adults
• Intervention / Treatment: Behavioral: Virtual Coaching and social support

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 Type: Interventional
• Enrollment (Estimated): 286
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julia von Oppenfeld; Phone Number: 415-676-1153; Email: julia.vonoppenfeld@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Contact: Julia von Oppenfeld; Phone Number: 415-676-1153; Email: julia.vonoppenfeld@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Study population: We will recruit 286 older adults who are 55 years and older with qualifying diagnoses for cardiac rehabilitation (CR).

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile app + Social; The intervention group will also receive Virtual coaching. The coach will evaluate goals, progress, facilitators (use of the buddy system) and challenges with an emphasis on forming healthy PA habits that will be sustained long-term over the life course. Social support: For the social support component, we will provide ground rules for communication (e.g., positive posts, use of "likes", comments, etc.). Groups will be comprised of 4-6 participants with consecutive recruitment.	Behavioral: Virtual Coaching and social support; The investigators propose a randomized clinical trial (RCT) of a virtual coaching and social support intervention that integrates evidence- and theory-based approaches to build self-efficacy, self-regulation, and perceived social support after cardiac rehabilitation (CR) to improve physical activity, psychosocial, social cognitive, and clinical outcomes, delivered via a social networking platform (Trainerize). Our intervention will also include goal setting for exercise and tailored feedback by our qualified intervention team.
No Intervention: Mobile App Alone; Mobile app control group. Exposure time will be similar between participants in both the intervention and control groups as both will have: (1) continuous access to the app for self-monitoring of exercise, blood pressure, and weight; (2) weekly "push" text messages with access to a library of educational content for learning that is self-paced on the app over 6 months; and (3) assigned 1 video per month on a variety of health topics related to older adults via the app that match exposure time (approximately 20-30 minutes) with the intervention group. The videos will be created or resourced from reputable organizations. The coach will send weekly short one-way messages on goals, self-management, etc. that the intervention group will also receive. The 1-way messages will be derived from a bank of 210 secondary prevention messages for CVD (PA, nutrition, stress management, heart disease facts, etc.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step counts	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.	At baseline, 3, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity, barriers and sedentary time: Rapid Assessment of Physical Activity scale	This 9-item questionnaire assesses self-reported physical activity (higher score indicates higher activity, scored 0-9)	Baseline, 3, 6, and 12 months
Physical Activity, barriers and sedentary time: Exercise Barriers Scale	This 14-item questionnaire assesses exercise barriers. (Higher score associated with more positive perceptions of exercise, scored 14-56)	Baseline, 3, 6, and 12 months
Physical Activity, barriers and sedentary time: Self-reported sedentary time	The modified 1-item International Physical Activity Questionnaire assesses self-reported sedentary time (minutes/hours per day)	Baseline, 3, 6, and 12 months
Functional fitness tests: sit-to-stand	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)	Baseline, 3, 6, and 12 months
Functional fitness tests: 2 minute step test	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)	Baseline, 3, 6, and 12 months
Functional fitness tests: dumbbell curl test	We will assess the functional fitness outcomes by performing the dumbbell curl test (number of dumbbell curls within 30 seconds)	Baseline, 3, 6, and 12 months
Psychosocial factors: Depression	The 8-item Patient Health Questionnaire (PHQ-8) will be used to measure depressive symptoms (higher score associated worse depression, scored 0-24)	Baseline, 3, 6, and 12 months
Psychosocial factors: Loneliness	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)	Baseline, 3, 6, and 12 months
Social cognitive factors: Self-efficacy	The 9-item Self-efficacy for Exercise scale uses components of Social Cognitive Theory (higher score associated higher self-efficacy, scored 0-90)	Baseline, 3, 6, and 12 months
Social cognitive factors: Self-regulation	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)	Baseline, 3, 6, and 12 months
Social cognitive factors: Perceived social support	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)	Baseline, 3, 6, and 12 months
CV risk factors: hyperlipidemia	Lipids assessed from blood test results from the electronic medical record (EMR)	Baseline, 3, 6, 12, and 18 months
CV risk factors: hypertension	Hypertension assessed from blood pressure results from the electronic medical record (EMR)	Baseline, 3, 6, 12, and 18 months
CV risk factors: diabetes	Hemoglobin A1c assessed from blood test results from the electronic medical record (EMR)	Baseline, 3, 6, 12, and 18 months
CV risk factors: obesity	BMI assessed from the electronic medical record (EMR)	Baseline, 3, 6, 12, and 18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac events and rehospitalization trends: Cardiac events	Number of occurrences of cardiac events (e.g., myocardial infarction, revascularization) collected via EMR/self-report	3, 6, 12, and 18 months
Cardiac events and rehospitalization trends: Rehospitalizations	Number rehospitalizations (cardiac and non-cardiac causes) collected via EMR/self-report	3, 6, 12, and 18 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of California, Davis
• Investigators: Principal Investigator: Linda Park, PhD, NP, University of California, San Francisco

Publications and helpful links

General Publications

• Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044.
• Moore SM, Charvat JM, Gordon NH, Pashkow F, Ribisl P, Roberts BL, Rocco M. Effects of a CHANGE intervention to increase exercise maintenance following cardiac events. Ann Behav Med. 2006 Feb;31(1):53-62. doi: 10.1207/s15324796abm3101_9.
• Ades PA, Maloney A, Savage P, Carhart RL Jr. Determinants of physical functioning in coronary patients: response to cardiac rehabilitation. Arch Intern Med. 1999 Oct 25;159(19):2357-60. doi: 10.1001/archinte.159.19.2357.
• Hellman EA. Use of the stages of change in exercise adherence model among older adults with a cardiac diagnosis. J Cardiopulm Rehabil. 1997 May-Jun;17(3):145-55. doi: 10.1097/00008483-199705000-00001.
• Elnaggar A, von Oppenfeld J, Whooley MA, Merek S, Park LG. Applying Mobile Technology to Sustain Physical Activity After Completion of Cardiac Rehabilitation: Acceptability Study. JMIR Hum Factors. 2021 Sep 2;8(3):e25356. doi: 10.2196/25356.
• Stafford M, von Wagner C, Perman S, Taylor J, Kuh D, Sheringham J. Social connectedness and engagement in preventive health services: an analysis of data from a prospective cohort study. Lancet Public Health. 2018 Sep;3(9):e438-e446. doi: 10.1016/S2468-2667(18)30141-5. Epub 2018 Aug 22.
• Holt-Lunstad J, Robles TF, Sbarra DA. Advancing social connection as a public health priority in the United States. Am Psychol. 2017 Sep;72(6):517-530. doi: 10.1037/amp0000103.
• Leon AS, Franklin BA, Costa F, Balady GJ, Berra KA, Stewart KJ, Thompson PD, Williams MA, Lauer MS; American Heart Association; Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention); Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity); American association of Cardiovascular and Pulmonary Rehabilitation. Cardiac rehabilitation and secondary prevention of coronary heart disease: an American Heart Association scientific statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity), in collaboration with the American association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2005 Jan 25;111(3):369-76. doi: 10.1161/01.CIR.0000151788.08740.5C.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2025
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Actual): November 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Adherence; Physical Activity; Cardiac rehabilitation; m-Health; Social support
• Other Study ID Numbers: 24-41119; 1R01HL171287 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No