Heart Failure Exercise And Resistance Training Camp (HEART Camp) (HEART Camp)
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|ClinicalTrials.gov Identifier: NCT01771900|
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : January 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Behavioral: Heart Camp Group Behavioral: Attention Control Group||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Heart Failure Exercise and Resistance Training CAMP|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
|Experimental: Heart Camp Group||
Behavioral: Heart Camp Group
In Week 1, 2, and 3 subjects will attend the HEART CAMP. Subjects will set specific exercise goals. Subjects will be taught how to record exercise data on the computer at the exercise facility. Specific activities will teach subjects aerobic and resistance training exercises and build self-efficacy to exercise. During the period from month 3 to the end of study subjects will continue the training program independently and no formal sessions will be scheduled.
|Experimental: Attention Control Group||
Behavioral: Attention Control Group
Subjects will receive a 60 minute group session led by a specifically designated control group intervention nurse. Phone calls will be placed to the subject if they miss a Friday group session and attendance to meetings will be encouraged.
- Change in Adherence to Exercise [ Time Frame: Baseline to 3 months ]
- Change in Self-efficacy to exercise [ Time Frame: Baseline to three months ]Measured with the Cardiac Exercise Self-Efficacy Instrument
- Change in Estimated energy expenditure [ Time Frame: Baseline to three months ]Measured with the RT3 Accelerometer
- Change in Symptoms [ Time Frame: Baseline to three months ]Measured with the Dyspnea-Fatigue Index
- Change in Biomarkers [ Time Frame: Baseline to three months ]
- Change in Physical and psychological functioning [ Time Frame: Baseline to three months ]Measured by the MOS SF-36
- Quality of Life [ Time Frame: Baseline to three months ]Measured with the Kansas City Cardiomyopathy Questionnaire
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771900
|United States, Nebraska|
|BryanLGH Heart Institute|
|Lincoln, Nebraska, United States, 68506|
|Principal Investigator:||Bunny Pozehl, PhD, APRN-NP||University of Nebraska|