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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
Sponsor:
Information provided by (Responsible Party):
Paul J. Mills, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Behavioral: HEART-PLAY Behavioral: Standard Cardiac Rehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 295 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Experimental: HEART-PLAY
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.
Behavioral: HEART-PLAY
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Improved Cost-effectiveness [ Time Frame: 12 months ]
    Determine cost-effectiveness using Markov Models

  3. Change in BNP levels [ Time Frame: 3 months, 6 months, and 12 months ]
    Assess reductions in circulating cardiac health biomarkers using standard biomarkers assays

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, California
University of California, San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
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Responsible Party: Paul J. Mills, Professor IR, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03632018    
Other Study ID Numbers: 1R01HL136407 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paul J. Mills, University of California, San Diego:
cardiac rehabilitation
physical activity
Additional relevant MeSH terms:
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Cardiovascular Diseases