Heart Exercise And Resistance Training - Peer Lead ActivitY (HEART-PLAY)
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|ClinicalTrials.gov Identifier: NCT03632018|
Recruitment Status : Enrolling by invitation
First Posted : August 15, 2018
Last Update Posted : April 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Behavioral: HEART-PLAY Behavioral: Standard Cardiac Rehabilitation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||295 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Cluster randomized controlled trial|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Because we are intentionally changing the clinic environment, study participants and care providers will not be masked to the study condition. However, the investigator and the outcome assessors will be unaware which study arm a given participant is in to reduce bias.|
|Official Title:||Heart Exercise And Resistance Training - Peer Lead ActivitY (HEART-PLAY)|
|Actual Study Start Date :||August 22, 2018|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2023|
Active Comparator: Standard Cardiac Rehabilitation
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.
Behavioral: Standard Cardiac Rehabilitation
During the 12-week intervention period, the STANDARD intervention participants will receive standard of care by attending the 36 sessions of standard CR as prescribed by his/her physician and administered by the Step Clinic.
Participants in the HEART-PLAY will receive standard CR and additionally receive pedometers, resistance bands, and the National Institute of Aging (NIA) exercise guide. They 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 twice weekly group events including walks and/or resistance band group exercise classes.
Participants assigned to the HEART-PLAY intervention will receive standard CR. Additionally, they will receive pedometers, group education, and educational materials introduced by peer Health Coaches for 12 months. Before or after their regularly scheduled CR appointments, they will meet at the clinic as a group twice per week to receive Health Tips and participate in discussions. At 8 weeks in to the 12-week CR, they will begin to discuss with their peer Health Coaches the transition from the formal CR setting into community-based exercise. As part of this transition, peer Health Coaches will slowly introduce group community walks and train participants in the proper use of resistance bands. Health Coaches will have talk with their assigned participants about relapse prevention and sustaining exercise following the termination of formal CR.
- Change in Minutes of Moderate Physical Activity (PA) [ Time Frame: 3 months, 6 months, and 12 months ]7-day actigraphy records will be used to assess amount of moderate PA
- Change in Health-related quality of life (QoL) [ Time Frame: 3 months, 6 months, and 12 months ]Demonstrate improved QoL as determined by the NIH-supported PROMIS-29
- Improved Cost-effectiveness [ Time Frame: 12 months ]Determine cost-effectiveness using Markov Models
- Change in BNP levels [ Time Frame: 3 months, 6 months, and 12 months ]Assess reductions in circulating cardiac health biomarkers using standard biomarkers assays
- Change in Galectin-3 levels [ Time Frame: 3 months, 6 months, and 12 months ]Assess reductions in circulating cardiac health biomarkers using standard biomarkers assays
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03632018
|United States, California|
|University of California, San Diego|
|La Jolla, California, United States, 92093|