Heart Exercise And Resistance Training - Peer Lead ActivitY

NCT03632018 | Unknown

• 1 other identifier: 1R01HL136407
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

cardiac rehabilitation; physical activity

Outcome Measures

Primary Outcomes (1)

• Change in Minutes of Moderate Physical Activity (PA)

  7-day actigraphy records will be used to assess amount of moderate PA

  3 months, 6 months, and 12 months

Secondary Outcomes (4)

• Change in Health-related quality of life (QoL)

  3 months, 6 months, and 12 months

• Improved Cost-effectiveness

  12 months

• Change in BNP levels

  3 months, 6 months, and 12 months

• Change in Galectin-3 levels

  3 months, 6 months, and 12 months

Study Arms (2)

Standard Cardiac Rehabilitation

ACTIVE COMPARATOR

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

HEART-PLAY

EXPERIMENTAL

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

Interventions

HEART-PLAY BEHAVIORAL

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.

HEART-PLAY

Standard Cardiac Rehabilitation BEHAVIORAL

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.

Standard Cardiac Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor IR

Model Details: Cluster randomized controlled trial

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 15, 2018
• Study Start: August 22, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)