NCT03632018: HEART-PLAY

Heart Exercise And Resistance Training - Peer Lead ActivitY

Status unknown NA Last updated 9 April 2021

What this trial tests

NA trial testing HEART-PLAY in Cardiovascular Diseases in 295 participants. Status unknown.

Timeline

22 August 2018

Primary endpoint
31 December 2022

31 December 2023

Quick facts

Lead sponsor	University of California, San Diego
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	295
Start date	22 August 2018
Primary completion	31 December 2022
Estimated completion	31 December 2023
Sites	1 location across United States

Drugs / interventions tested

• HEART-PLAY
• Standard Cardiac Rehabilitation

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

University of California, San Diego

Who can join

18 and older, any sex, with Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Social network interventions to support cardiac rehabilitation and secondary prevention in the management of people with heart disease.
   Purcell C, Dibben G, Hilton Boon M, Matthews L, et al · · 2023 · cited 17× · PMID 37378598 · DOI 10.1002/14651858.cd013820.pub2