Clinical trial NCT03632018: Heart Exercise And Resistance Training - Peer Lead ActivitY
Official title: Heart Exercise And Resistance Training - Peer Lead ActivitY (HEART-PLAY)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: cardiac rehabilitation
physical activity
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Numerous studies show that regular physical activity / exercise significantly improves exercise tolerance as well as clinical outcomes in cardiovascular disease (CVD). Exercise as a reliable adjunctive intervention, however, remains limited due to poor short- as well as long-term adherence. The study examines the effectiveness of the peer-led Heart Exercise And Resistance Training - Peer Lead ActivitY (HEART-PLAY) intervention to significantly sustain exercise adherence among CR patients, as compared a standard CR intervention. In a rigorous cluster randomized controlled trial at the UCSD Step Family Cardiovascular Rehabilitation and Wellness Center, the study assesses the HEART-PLAY intervention program in 264 socioeconomically and ethnically diverse women and men 18+ years old who have been referred to standard CR. Participants in the HEART-PLAY and in the STANDARD CR programs will both participate in 36 sessions of CR across approximately 12 weeks, as prescribed by their physician. Participants in HEART-PLAY will additionally receive peer and staff leadership, self-monitoring tools and feedback, group education and materials, and motivational, goal-setting, and relapse prevention counseling sessions. The study will demonstrate that the peer-led HEART-PLAY program based in the clinic setting will significantly enhance the primary study endpoint of adherence to 150 min/week of moderate physical activity/week.

Detailed description: This study examines the effectiveness of the Heart Exercise And Resistance Training - Peer Lead ActivitY (HEART-PLAY) intervention to significantly sustain exercise adherence in patients referred for Cardiac Rehabilitation (CR). CR Clinic staff and CR patients who meet study inclusion criteria and are willing to serve as peer leaders, will be taught to lead the intervention activities with trained health educators and research staff. The HEART-PLAY program and behavior change will be sustainable because of the presence of peer and staff leadership and because it employs proven strategies from social cognitive theory and ecological models including self-monitoring, feedback, social support, role modeling, and relapse prevention. HEART-PLAY teaches patients how to accumulate meaningful PA across the day and provides a supportive social infrastructure to maintain motivation. Since the aim is to test an augmented CR program that can be widely adopted, the project employs a design that allows for the concurrent testing of both intervention and implementation strategies and outcomes. Across the five days of the week and the AM and PM clinic sessions, there will be approximately 25 different peer-led groups (clusters) run to obtain complete data on a total of 264 women and men 18+ years old of varied socioeconomic and ethnic backgrounds referred for CR. HEART-PLAY and STANDARD participants will be scheduled to visit the Step Clinic on distinctly different days/times to avoid contamination. Participants in the STANDARD condition will receive the standard of care cardiac rehabilitation, consisting of 36 sessions across 12 weeks of prescribed, supervised exercise sessions, Participants in the HEART-PLAY will receive standard CR and additionally receive pedometers, resistance bands, and the National Institute of Aging (NIA) exercise guide. Patients will further receive counseling from peer health coaches, social support from group education sessions, and supplemental educational materials. After the 12 weeks of prescribed, supervised exercise sessions, HEART-PLAY group participants will continue to receive support from peers and clinic staff with check-in calls, feedback on pedometer goals, and bi-weekly group events including walks and/or resistance band group exercise classes. Pilot data support that the peer-led approach in the clinic setting will be enthusiastically received by patients and significantly increase PA and adherence.

Eligibility criteria: Inclusion Criteria:

* Age 18+
* Referred to the UCSD Step Clinic for 36 sessions of cardiac rehabilitation across 12-14 weeks for one of the following medical conditions: myocardial infarction, coronary artery bypass surgery, stable angina, heart valve repair or replacement, coronary angioplasty or stenting, or congestive heart failure.
* Able to give informed consent in English
* Able to perform study assessments as described
* Blood pressure \<180/110 mmHg
* Able to perform light to moderate exercise
* Have not had a fall during the previous 6 months resulting in an injury
* Clinical staff's permission to participate, including their assessment that participant is a good candidate for this particular research study
* Ability to complete written or computer-based surveys
* Completion of a post-consent comprehension test

Exclusion Criteria:

* Referred to CR following VAD (Ventricular Assist Device) procedure, peripheral arterial disease (PAD), or heart or lung transplant. Angina not adequately managed with nitrates
* Oxygen-dependent COPD
* Recent stroke or significant cerebral neurologic impairment that would interfere with participation
* Major depressive disorder per eMR

Primary outcomes:
measure: Change in Minutes of Moderate Physical Activity (PA)
timeFrame: 3 months, 6 months, and 12 months
Secondary outcomes:
measure: Change in Health-related quality of life (QoL)
timeFrame: 3 months, 6 months, and 12 months
measure: Improved Cost-effectiveness
timeFrame: 12 months
measure: Change in BNP levels
timeFrame: 3 months, 6 months, and 12 months
measure: Change in Galectin-3 levels
timeFrame: 3 months, 6 months, and 12 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
References: