AzTrials
AzTrials

Adherence to Physical Activity After Completing Cardiac Rehabilitation (CR) in Older AdultsSTRIVENCT06701188

Supportive Training After Cardiac Rehabilitation Including Virtual Engagement

A study testing Virtual Coaching and social support in people with Adherence to Physical Activity After Completing Cardiac Rehabilitation (CR) in Older Adults, run by University of California, San Francisco at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 55 to 100 years
What is being tested?
Virtual Coaching and social support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
286 participants
Where
1 siteUnited States
Study dates
13 May 2025to 30 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Participation in Phase III CR (optional extended CR after outpatient Phase II CR for those who pay out-of-pocket)
  • Cognitive impairment (per Mini-Cog assessment tool with score 0-2)
  • Lack of English or Spanish proficiency/literacy
  • Clinical conditions including:
  • Unstable arrhythmias, aortic stenosis, thrombophlebitis, dissecting aneurysm or symptomatic anemia
  • Active infection
Show all 10Show fewer
  • Uncontrolled hypertension: resting systolic >180 mmHg, diastolic >100 mmHg
  • Decompensated heart failure, NYHA Class III-IV
  • Current unstable angina
  • 2nd or 3rd degree heart block or exercise induced arrhythmias

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Julia von Oppenfeld contact

415-676-1153

julia.vonoppenfeld@ucsf.edu

United States1 site, 1 recruiting
  • University of California, San Francisco

    San Francisco, California, 94143

    Julia von Oppenfeld, 415-676-1153, julia.vonoppenfeld@ucsf.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Virtual Coaching and social support
Keywords
Cardiac rehabilitation, Adherence, Cardiovascular disease, m-Health, Physical Activity, Social support
Medical subject headings
Cardiovascular Diseases, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Coaching and social supportBehavioural

    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.

Study groups in NCT06701188
Study groupRoleWhat they receive
Mobile App AloneNo interventionMobile 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.).
Mobile app + SocialExperimentalThe 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.
Receives: Behavioral: Virtual Coaching and social support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline, 3, and 6 months

Secondary outcomes (15)
  1. 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)

    Measured: Baseline, 3, 6, and 12 months

  2. 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)

    Measured: Baseline, 3, 6, and 12 months

  3. 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)

    Measured: Baseline, 3, 6, and 12 months

  4. 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)

    Measured: Baseline, 3, 6, and 12 months

  5. 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)

    Measured: Baseline, 3, 6, and 12 months

  6. 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)

    Measured: Baseline, 3, 6, and 12 months

  7. 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)

    Measured: Baseline, 3, 6, and 12 months

  8. 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)

    Measured: Baseline, 3, 6, and 12 months

  9. 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)

    Measured: Baseline, 3, 6, and 12 months

  10. 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)

    Measured: Baseline, 3, 6, and 12 months

  11. 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)

    Measured: Baseline, 3, 6, and 12 months

  12. CV risk factors: hyperlipidemia

    Lipids assessed from blood test results from the electronic medical record (EMR)

    Measured: Baseline, 3, 6, 12, and 18 months

  13. CV risk factors: hypertension

    Hypertension assessed from blood pressure results from the electronic medical record (EMR)

    Measured: Baseline, 3, 6, 12, and 18 months

  14. CV risk factors: diabetes

    Hemoglobin A1c assessed from blood test results from the electronic medical record (EMR)

    Measured: Baseline, 3, 6, 12, and 18 months

  15. CV risk factors: obesity

    BMI assessed from the electronic medical record (EMR)

    Measured: Baseline, 3, 6, 12, and 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2024
  2. Study start13 May 2025
  3. Primary completion31 Mar 2029 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
286 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06701188
Sponsor's protocol ID
24-41119
Other IDs
1R01HL171287
Acronym
STRIVE
Status last verified
Jul 2025
First submitted
5 Nov 2024
Last updated
29 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 15668354
  • 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.

    PubMed 10547176
  • 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.

    PubMed 26764059
  • 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.

    PubMed 9187980
  • 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.

    PubMed 16472039
  • 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.

    PubMed 34473064
  • 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.

    PubMed 30143472
  • 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.

    PubMed 28880099

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Coaching and social support in people with Adherence to Physical Activity After Completing Cardiac Rehabilitation (CR) in Older Adults, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Julia von Oppenfeld (415-676-1153, julia.vonoppenfeld@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Step counts (time frame: At baseline, 3, and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06701188, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in