Heart Failure Exercise And Resistance Training Camp (HEART Camp)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bunny J. Pozehl, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01771900
First received: June 15, 2012
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Heart Failure
Behavioral: Heart Camp Group
Behavioral: Attention Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Heart Failure Exercise and Resistance Training CAMP

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Change in Adherence to Exercise [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
  • Change in Self-efficacy to exercise [ Time Frame: Baseline to three months ] [ Designated as safety issue: No ]
    Measured with the Cardiac Exercise Self-Efficacy Instrument

  • Change in Estimated energy expenditure [ Time Frame: Baseline to three months ] [ Designated as safety issue: No ]
    Measured with the RT3 Accelerometer


Secondary Outcome Measures:
  • Change in Symptoms [ Time Frame: Baseline to three months ] [ Designated as safety issue: No ]
    Measured with the Dyspnea-Fatigue Index

  • Change in Biomarkers [ Time Frame: Baseline to three months ] [ Designated as safety issue: No ]
  • Change in Physical and psychological functioning [ Time Frame: Baseline to three months ] [ Designated as safety issue: No ]
    Measured by the MOS SF-36

  • Quality of Life [ Time Frame: Baseline to three months ] [ Designated as safety issue: No ]
    Measured with the Kansas City Cardiomyopathy Questionnaire


Enrollment: 42
Study Start Date: April 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771900

Locations
United States, Nebraska
BryanLGH Heart Institute
Lincoln, Nebraska, United States, 68506
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Bunny Pozehl, PhD, APRN-NP University of Nebraska
  More Information

Publications:
Responsible Party: Bunny J. Pozehl, Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT01771900     History of Changes
Other Study ID Numbers: 050-05-FB, 1R15NR009215-01
Study First Received: June 15, 2012
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
heart failure
exercise
adherence to exercise

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014