Heart Failure Exercise And Resistance Training Camp (HEART Camp)

NCT ID: NCT01771900

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-01
• Study Completion Date: 2007-12-26

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

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Heart Camp Group

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Attention Control Group

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bunny Pozehl, PhD, APRN-NP

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

BryanLGH Heart Institute

Lincoln, Nebraska, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20598373 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19561522 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22099469 (View on PubMed)

Other Identifiers

1R15NR009215-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0050-05-FB

Identifier Type: -

Identifier Source: org_study_id