Overview

This trial is active, not recruiting.

Condition heart failure
Treatments standard care exercise group, heart camp exercise group
Sponsor University of Nebraska
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date April 2012
End date December 2016
Trial size 246 participants
Trial identifier NCT01658670, 1R01HL112979, 608-11-FB

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(Active Comparator)
Standard care exercise group
standard care exercise group
The SC group is provided access to the exercise facility and regular facility staff for the 18 month study period.
(Experimental)
HEART Camp Exercise Group
heart camp exercise group
The HC intervention group will be provided access to the exercise facility for the 18 month study period and will also receive cognitive-behavioral strtegies that address the intervention components of knowledge, attitudes, self-efficacy, behavioral self-management skills and social support.

Primary Outcomes

Measure
Adherence to exercise.
time frame: 18 months

Eligibility Criteria

Male or female participants at least 19 years old.

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 less than 3 months ago - orthopedic or neuromuscular disorders preventing participation in aerobic exercise and strength/resistance training - participation in 3 times per week aerobic exercise during the past 6 months - cardiopulmonary stress test results that preclude safe exercise training - plans to move more than 50 miles from the exercise site within the next year

Additional Information

Official title HEART Camp: Promoting Adherence to Exercise in Patients With Heart Failure
Principal investigator Bunny J Pozehl, PhD, RN
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 a standard care (SC) 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 SC 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 accelerometry and self-report); 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 (race, gender, age) 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Nebraska.