Clinical trial NCT01771900: Heart Failure Exercise And Resistance Training Camp (HEART Camp)
Official title: Heart Failure Exercise and Resistance Training CAMP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
exercise
adherence to exercise
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2013-01-18
Enrollment: 42
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this feasibility study was to obtain pilot data, as the basis for a future, larger investigation, testing the impact of an innovative training camp intervention called HEART CAMP (Heart failure Exercise And Resistance Training CAMP) to teach HF patients how to exercise and self-manage exercise behavior over time. The study assessed the feasibility and adequacy of the intervention, the data collection plan, and the reliability and sensitivity of the outcome measures. The 6-month intervention was based on a training camp model to teach HF patients how to exercise in a fun, group-oriented atmosphere. Subjects interacted and exercised in small groups with an exercise physiologist and nurse to guide activities. The dosage of the intervention (frequency and amount of direct guidance from the exercise physiologist and nurse) decreased over the 6 months in order to increase subject's independence and promote long-term adherence to exercise. The intervention incorporated use of computerized data files to monitor exercise behavior, compare exercise performance to individualized goals and provide feedback as strategies to foster adherence and self-management of exercise behavior.

Detailed description: This study uses an experimental repeated measures design with randomized comparison of the HEART CAMP intervention group and the attention control group. The purpose of this feasibility study is to obtain pilot data, as the basis for a future, larger investigation, testing the impact of an innovative 24-week (6-month) training camp intervention (HEART CAMP). HEART CAMP is designed to teach heart failure (HF) patients how to exercise (aerobic and resistance) and self-manage exercise behavior over time. Patients receiving care at the BryanLGH Heart Institute heart failure clinic will be eligible for the study.

The HEART CAMP intervention is a multi-component intervention derived from Bandura's cognitive behavioral theory and consists of specific strategies to build self-efficacy for exercise. The subject, under the guidance of an exercise physiologist and nurse, will be taught how to exercise (aerobic and resistance). A baseline cardiopulmonary exercise test will be completed on all subjects. The first three weeks of HEART CAMP will be held in a hospital based cardiac rehabilitation department where subjects will be electrocardiographically monitored during the five-day per week training sessions. Training sessions will be delivered in cohort groups of eight subjects and will focus on exercise, self-evaluation of response to exercise, and group debriefing sessions for problem solving and relapse management. Weeks 4 through 12 subjects will complete three aerobic exercise sessions in the cardiac rehabilitation maintenance facility and two resistive training sessions at home with the exercise physiologist and nurse monitoring subject response and delivering group debriefing sessions each week. Weeks 12 through 24 subjects exercise independently with the exercise physiologist and nurse monitoring subject exercise data and available as needed.

The attention control group will receive weekly cohort group education sessions during the first 3 months similar to the intervention groups' participation in weekly group sessions. One week an educational topic will be presented and the subsequent week the cohort group of eight subjects will discuss the topic. Six topics will be presented including: Eating Fruits, Vegetables, and Grains; Shopping Wisely; Cooking Healthy; Time Management; Communicating Assertively; and Learning to Relax.

Outcome measures will be completed at baseline, 3 weeks, 3 and 6 months (end of study) for both groups. Primary outcomes are estimated energy expenditure, self-efficacy to exercise, and adherence to exercise. Secondary outcomes are symptoms, biomarker (BNP), physical and psychological functioning and quality of life

Eligibility criteria: Inclusion Criteria:

* 19 years of age or greater
* Oriented to person, place, time
* Able to speak and read English
* Resting left ventricular ejection fraction of 40% of less
* Optimum stable medical therapy 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 exercise and strength/resistance training
* Participation in 3 times per week aerobic exercise during the past 12 months.

Primary outcomes:
measure: Adherence to Exercise
timeFrame: Baseline to 3 months
measure: Change in Self-efficacy to exercise
timeFrame: Baseline to three months
measure: Change in Estimated energy expenditure
timeFrame: Baseline to three months
Secondary outcomes:
measure: Change in Symptoms
timeFrame: Baseline to three months
measure: Change in Biomarkers
timeFrame: Baseline to three months
measure: Change in Physical and psychological functioning
timeFrame: Baseline to three months
measure: Heart failure symptoms impact on physical and social function and quality of life
timeFrame: Baseline to three months
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: BryanLGH Heart Institute
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Bunny Pozehl, PhD, APRN-NP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pozehl B, Duncan K, Hertzog M, Norman JF. Heart Failure Exercise And Training Camp: effects of a multicomponent exercise training intervention in patients with heart failure. Heart Lung. 2010 Nov-Dec;39(6 Suppl):S1-13. doi: 10.1016/j.hrtlng.2010.04.008. Epub 2010 Jul 3.
citation: Norman JF, Pozehl BJ, Duncan KA, Hertzog MA, Elokda AS, Krueger SK. Relationship of resting B-type natriuretic peptide level to cardiac work and total physical work capacity in heart failure patients. J Cardiopulm Rehabil Prev. 2009 Sep-Oct;29(5):310-3. doi: 10.1097/HCR.0b013e3181ac7bcb.
citation: Duncan K, Pozehl B, Norman JF, Hertzog M. A self-directed adherence management program for patients with heart failure completing combined aerobic and resistance exercise training. Appl Nurs Res. 2011 Nov;24(4):207-14. doi: 10.1016/j.apnr.2009.08.003. Epub 2009 Oct 15.