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Heart Failure Exercise And Resistance Training Camp (HEART Camp) (HEART)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heart Camp Group
Attention Control Group
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring heart failure, exercise, adherence to exercise

Eligibility Criteria

19 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • BryanLGH Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Heart Camp Group

Attention Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Adherence to Exercise
Change in adherence to exercise as recorded in digital diary
Change in Self-efficacy to exercise
Measured with the Cardiac Exercise Self-Efficacy Instrument
Change in Estimated energy expenditure
Measured with the RT3 Accelerometer

Secondary Outcome Measures

Change in Symptoms
Measured with the Dyspnea-Fatigue Index
Change in Biomarkers
BNP is an effective, reliable and powerful cardiac biomarker for early diagnosis heart failure (HF). BNP are small proteins produced in left-ventricular myocardium, when there is an excess of fluids that causes myocardial stretch. The normal concentration of BNP in blood is 35pg/mL.
Change in Physical and psychological functioning
Measured by the MOS SF-36
Heart failure symptoms impact on physical and social function and quality of life
Measured with the Kansas City Cardiomyopathy Questionnaire, a self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life.

Full Information

First Posted
June 15, 2012
Last Updated
August 29, 2023
Sponsor
University of Nebraska
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT01771900
Brief Title
Heart Failure Exercise And Resistance Training Camp (HEART Camp)
Acronym
HEART
Official Title
Heart Failure Exercise and Resistance Training CAMP
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2005 (Actual)
Primary Completion Date
December 26, 2007 (Actual)
Study Completion Date
December 26, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, exercise, adherence to exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heart Camp Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control Group
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Heart Camp Group
Intervention Description
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
Intervention Name(s)
Attention Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence to Exercise
Description
Change in adherence to exercise as recorded in digital diary
Time Frame
Baseline to 3 months
Title
Change in Self-efficacy to exercise
Description
Measured with the Cardiac Exercise Self-Efficacy Instrument
Time Frame
Baseline to three months
Title
Change in Estimated energy expenditure
Description
Measured with the RT3 Accelerometer
Time Frame
Baseline to three months
Secondary Outcome Measure Information:
Title
Change in Symptoms
Description
Measured with the Dyspnea-Fatigue Index
Time Frame
Baseline to three months
Title
Change in Biomarkers
Description
BNP is an effective, reliable and powerful cardiac biomarker for early diagnosis heart failure (HF). BNP are small proteins produced in left-ventricular myocardium, when there is an excess of fluids that causes myocardial stretch. The normal concentration of BNP in blood is 35pg/mL.
Time Frame
Baseline to three months
Title
Change in Physical and psychological functioning
Description
Measured by the MOS SF-36
Time Frame
Baseline to three months
Title
Heart failure symptoms impact on physical and social function and quality of life
Description
Measured with the Kansas City Cardiomyopathy Questionnaire, a self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life.
Time Frame
Baseline to three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bunny Pozehl, PhD, APRN-NP
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
BryanLGH Heart Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20598373
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.
Results Reference
result
PubMed Identifier
19561522
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.
Results Reference
result
PubMed Identifier
22099469
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.
Results Reference
result

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Heart Failure Exercise And Resistance Training Camp (HEART Camp)

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