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Completed

NCT Number: NCT01658670

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Health System, Detroit, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced Usual Care Group

Behavioral

The EUC group is provided access to the exercise facility and regular facility staff for the 18 month study period.

HEART Camp (HC) Intervention Group

Behavioral

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.

Primary outcomes

  1. Adherence to exercise.

    Time frame: 18 months

    Adherence to exercise with 18 months as the primary outcome time point.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

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

Registry information

Acronym: HEART

Important dates

Study start
2012
Primary completion
2016
Study completion
2018
First posted
Aug 7, 2012
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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