Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT03632018 |
| Other study ID # |
1R01HL136407 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 22, 2018 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
April 2021 |
| Source |
University of California, San Diego |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
