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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-01

Study Completion Date

2018-03-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care Group

Intervention Type 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

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.

Group Type EXPERIMENTAL

HEART Camp (HC) Intervention Group

Intervention Type 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.

Interventions

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Enhanced Usual Care Group

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No