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

Heart Failure Clinical Trial

— HEART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01658670
• Other study ID #: 0608-11-FB
• Secondary ID: 1R01HL112979
• Status: Completed
• Phase: N/A
• Start date: April 1, 2012
• Est. completion date: March 1, 2018

Study information

• Verified date: November 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: March 1, 2018
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan
United States	Wayne State University	Detroit	Michigan
United States	University of Nebraska Medical Center, College of Nursing	Omaha	Nebraska

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

References & Publications (4)

Brawner CA, Ehrman JK, Myers J, Chase P, Vainshelboim B, Farha S, Saval MA, McGuire R, Pozehl B, Keteyian SJ. Exercise Oscillatory Ventilation: Interreviewer Agreement and a Novel Determination. Med Sci Sports Exerc. 2018 Feb;50(2):369-374. doi: 10.1249/M — View Citation

Pozehl BJ, Duncan K, Hertzog M, McGuire R, Norman JF, Artinian NT, Keteyian SJ. Study of adherence to exercise in heart failure: the HEART camp trial protocol. BMC Cardiovasc Disord. 2014 Nov 29;14:172. doi: 10.1186/1471-2261-14-172. — View Citation

Pozehl BJ, Mcguire R, Duncan K, Hertzog M, Deka P, Norman J, Artinian NT, Saval MA, Keteyian SJ. Accelerometer-Measured Daily Activity Levels and Related Factors in Patients With Heart Failure. J Cardiovasc Nurs. 2018 Jul/Aug;33(4):329-335. doi: 10.1097/J — View Citation

Pozehl BJ, McGuire R, Duncan K, Kupzyk K, Norman J, Artinian NT, Deka P, Krueger SK, Saval MA, Keteyian SJ. Effects of the HEART Camp Trial on Adherence to Exercise in Patients With Heart Failure. J Card Fail. 2018 Oct;24(10):654-660. doi: 10.1016/j.cardf — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to exercise.	Adherence to exercise with 18 months as the primary outcome time point.	18 months