HEART Camp: Promoting Adherence to Exercise in Patients With Heart Failure (HEART)

November 7, 2023 updated by: University of Nebraska
The purpose of this study is to determine the efficacy of the Heart Failure Exercise and Resistance Training (HEART) Camp behavioral exercise training intervention on long-term adherence to exercise at 18 months in patients with heart failure. The central hypothesis is that the HEART Camp intervention group (HC) will have significantly better adherence to exercise at 18 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this prospective randomized two-group repeated measures experimental design is to determine the efficacy of the HEART (Heart Failure Exercise and Resistance Training) Camp behavioral exercise training intervention on long-term adherence to exercise at 18 months in patients with HF. A sample size of 246 subjects with heart failure will be recruited over a 3 year period. All subjects will receive a cardiopulmonary exercise test and 9 supervised exercise training sessions during a 3 week run-in period prior to randomization. Subjects completing 6 of 9 training sessions will be randomized to the HEART Camp Intervention group (HC) or to an enhanced usual care (EUC) exercise group. The HC intervention group will receive cognitive-behavioral strategies that address the intervention components of knowledge, attitudes, self-efficacy, behavioral self-management skills and social support. The EUC group is provided access to the exercise facility and regular facility staff for the 18 month study period. Our central hypothesis is that the HC group will have significantly better adherence to exercise at 18 months. We will test our hypothesis with the following Specific Aims: Aim 1. To evaluate the effect of HEART Camp on adherence to exercise (measured by self-report and validated by heart rate monitor); Aim 2. To evaluate which components of the HEART Camp intervention mediate the effects of the intervention on adherence; Aim 3. To evaluate the effect of HEART Camp on specific health outcomes; Aim 4. To explore selected demographic variables (age, race, gender, body mass index and left ventricular ejection fraction) as potential moderators of the effect of the HEART Camp intervention on adherence; and Aim 5. To explore the perceptions and experiences that contextualize exercise adherence.

Study Type

Interventional

Enrollment (Actual)

245

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Detroit, Michigan, United States, 48202
        • Wayne State University
    • Nebraska
      • Omaha, Nebraska, United States, 68198-5330
        • University of Nebraska Medical Center, College of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of heart failure (stage C chronic HF confirmed by echocardiography and clinical evaluation)
  • 19 years of age or greater
  • able to speak and read English
  • telephone access in home
  • Stable pharmacologic therapy per guidelines for past 30 days

Exclusion Criteria:

  • clinical evidence of decompensated HF
  • unstable angina pectoris
  • myocardial infarction, coronary artery bypass surgery, or biventricular pacemaker within the past 6 weeks
  • orthopedic or neuromuscular disorders preventing participation in aerobic exercise and strength/resistance training
  • participation in 3 times per week aerobic exercise during the past 8 weeks
  • cardiopulmonary stress test results that preclude safe exercise training
  • plans to move more than 50 miles from the exercise site within the next year
  • peak oxygen uptake (pVO2) in women>21mL kg min and in men >24mLkg min
  • planned or current pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Enhanced Usual Care (EUC) exercise group
The EUC group is provided paid access to the exercise facility and has access to regular facility staff for the 18 month study period.
Behavioral: Enhanced Usual Care Group
The EUC group is provided access to the exercise facility and regular facility staff for the 18 month study period.
Experimental: HEART Camp (HC) Intervention group
The HC intervention group will be provided paid access to the exercise facility for the 18 month study period and will also receive the cognitive-behavioral intervention (knowledge, attitudes, self-efficacy, behavioral self-management skills and social support) delivered using both group-based and individual-based strategies.
Behavioral: HEART Camp (HC) Intervention Group
The HC intervention group will be provided access to the exercise facility for the 18 month study period and will also receive the cognitive-behavioral intervention (knowledge, attitudes, self-efficacy, behavioral self-management skills and social support) delivered using both group-based and individual-based strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to exercise.
Time Frame: 18 months
Adherence to exercise with 18 months as the primary outcome time point.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Wayne State University
Henry Ford Health System
University of Nebraska Lincoln

Investigators

  • Principal Investigator: Bunny J Pozehl, PhD, RN, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

July 31, 2012

First Submitted That Met QC Criteria

August 2, 2012

First Posted (Estimated)

August 7, 2012

Study Record Updates

Last Update Posted (Actual)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0608-11-FB
  • 1R01HL112979 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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