RECRUITING

Supportive Training After Cardiac Rehabilitation Including Virtual Engagement

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-13
Study Completion:2029-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06701188

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ≥ 55 years of age
  2. 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. 3. Adherence to CR ( ≥ 50% sessions for ≥ 1 month)
  1. 1. Participation in Phase III CR (optional extended CR after outpatient CR for those who pay out-of-pocket)
  2. 2. Cognitive impairment (score 0-2 per Mini-Cog)
  3. 3. Lack of English or Spanish proficiency/literacy
  4. 4. Unstable clinical conditions
  5. 1. Unstable arrhythmias, aortic stenosis, thrombophlebitis, dissecting aneurysm or symptomatic anemia
  6. 2. Active infection
  7. 3. Uncontrolled hypertension: resting systolic \>180 mmHg, diastolic \>100 mmHg
  8. 4. Decompensated heart failure, New York Heart Association (NYHA) Class III-IV
  9. 5. Current unstable angina
  10. 6. 2nd or 3rd degree heart block or exercise induced arrhythmias

Contacts and Locations

Study Contact

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

Principal Investigator

Linda Park, PhD, NP
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Linda Park, PhD, NP, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-13
Study Completion Date2029-06-30

Study Record Updates

Study Start Date2025-05-13
Study Completion Date2029-06-30

Terms related to this study

Keywords Provided by Researchers

  • Cardiac rehabilitation
  • Adherence
  • Cardiovascular disease
  • m-Health
  • Physical Activity
  • Social support

Additional Relevant MeSH Terms

  • Physical Activity Maintenance
  • Lifestyle (Sedentary Behavior and Physical Activity)
  • Behavioral Intervention