Heart Failure Clinical Trial
HEART Camp: Promoting Adherence to Exercise in Patients With Heart Failure
Summary
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.
Full 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.
Eligibility Criteria
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
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There are 2 Locations for this study
Detroit Michigan, 48202, United States
Detroit Michigan, 48202, United States
Omaha Nebraska, 68198, United States
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