Clinical trial NCT01658670: HEART Camp: Promoting Adherence to Exercise in Patients With Heart Failure
Official title: HEART Camp: Promoting Adherence to Exercise in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
exercise
adherence
quality of life
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Wayne State University
name: Henry Ford Health System
name: University of Nebraska Lincoln
First posted: 2012-08-07
Enrollment: 245
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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

Primary outcomes:
measure: Adherence to exercise.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska Medical Center, College of Nursing
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Bunny J Pozehl, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.cardfail.2018.06.007. Epub 2018 Aug 16.
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/JCN.0000000000000464.
citation: 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/MSS.0000000000001423.
citation: Alonso WW, Kupzyk KA, Norman JF, Lundgren SW, Fisher A, Lindsey ML, Keteyian SJ, Pozehl BJ. The HEART Camp Exercise Intervention Improves Exercise Adherence, Physical Function, and Patient-Reported Outcomes in Adults With Preserved Ejection Fraction Heart Failure. J Card Fail. 2022 Mar;28(3):431-442. doi: 10.1016/j.cardfail.2021.09.003. Epub 2021 Sep 15.