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HEART Camp: Promoting Adherence to Exercise in Patients With Heart Failure (HEART Camp)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01658670
Recruitment Status : Completed
First Posted : August 7, 2012
Last Update Posted : March 4, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Wayne State University
Henry Ford Health System
University of Nebraska Lincoln
Information provided by (Responsible Party):
Bunny J. Pozehl, University of Nebraska

Brief Summary:
The purpose of this study is to determine the efficacy of the Heart Failure Exercise and Resistance Training (HEART) Camp behavioral exercise training intervention on long-term adherence to exercise at 18 months in patients with heart failure. The central hypothesis is that the HEART Camp intervention group (HC) will have significantly better adherence to exercise at 18 months.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Enhanced Usual Care Group Behavioral: HEART Camp (HC) Intervention Group Not Applicable

Detailed Description:
The objective of this prospective randomized two-group repeated measures experimental design is to determine the efficacy of the HEART (Heart Failure Exercise and Resistance Training) Camp behavioral exercise training intervention on long-term adherence to exercise at 18 months in patients with HF. A sample size of 246 subjects with heart failure will be recruited over a 3 year period. All subjects will receive a cardiopulmonary exercise test and 9 supervised exercise training sessions during a 3 week run-in period prior to randomization. Subjects completing 6 of 9 training sessions will be randomized to the HEART Camp Intervention group (HC) or to an enhanced usual care (EUC) exercise group. The HC intervention group will receive cognitive-behavioral strategies that address the intervention components of knowledge, attitudes, self-efficacy, behavioral self-management skills and social support. The EUC group is provided access to the exercise facility and regular facility staff for the 18 month study period. Our central hypothesis is that the HC group will have significantly better adherence to exercise at 18 months. We will test our hypothesis with the following Specific Aims: Aim 1. To evaluate the effect of HEART Camp on adherence to exercise (measured by self-report and validated by heart rate monitor); Aim 2. To evaluate which components of the HEART Camp intervention mediate the effects of the intervention on adherence; Aim 3. To evaluate the effect of HEART Camp on specific health outcomes; Aim 4. To explore selected demographic variables (age, race, gender, body mass index and left ventricular ejection fraction) as potential moderators of the effect of the HEART Camp intervention on adherence; and Aim 5. To explore the perceptions and experiences that contextualize exercise adherence.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: HEART Camp: Promoting Adherence to Exercise in Patients With Heart Failure
Study Start Date : April 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Enhanced Usual Care (EUC) exercise group
The EUC group is provided paid access to the exercise facility and has access to regular facility staff for the 18 month study period.
Behavioral: Enhanced Usual Care Group
The EUC group is provided access to the exercise facility and regular facility staff for the 18 month study period.

Experimental: HEART Camp (HC) Intervention group
The HC intervention group will be provided paid access to the exercise facility for the 18 month study period and will also receive the cognitive-behavioral intervention (knowledge, attitudes, self-efficacy, behavioral self-management skills and social support) delivered using both group-based and individual-based strategies.
Behavioral: HEART Camp (HC) Intervention Group
The HC intervention group will be provided access to the exercise facility for the 18 month study period and will also receive the cognitive-behavioral intervention (knowledge, attitudes, self-efficacy, behavioral self-management skills and social support) delivered using both group-based and individual-based strategies.




Primary Outcome Measures :
  1. Adherence to exercise. [ Time Frame: 18 months ]
    Adherence to exercise with 18 months as the primary outcome time point.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of heart failure (stage C chronic HF confirmed by echocardiography and clinical evaluation)
  • 19 years of age or greater
  • able to speak and read English
  • telephone access in home
  • Stable pharmacologic therapy per guidelines for past 30 days

Exclusion Criteria:

  • clinical evidence of decompensated HF
  • unstable angina pectoris
  • myocardial infarction, coronary artery bypass surgery, or biventricular pacemaker within the past 6 weeks
  • orthopedic or neuromuscular disorders preventing participation in aerobic exercise and strength/resistance training
  • participation in 3 times per week aerobic exercise during the past 8 weeks
  • cardiopulmonary stress test results that preclude safe exercise training
  • plans to move more than 50 miles from the exercise site within the next year
  • peak oxygen uptake (pVO2) in women>21mL kg min and in men >24mLkg min
  • planned or current pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658670


Locations
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United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Wayne State University
Detroit, Michigan, United States, 48202
United States, Nebraska
University of Nebraska Medical Center College of Nursing
Omaha, Nebraska, United States, 68198-5330
Sponsors and Collaborators
University of Nebraska
National Heart, Lung, and Blood Institute (NHLBI)
Wayne State University
Henry Ford Health System
University of Nebraska Lincoln
Investigators
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Principal Investigator: Bunny J Pozehl, PhD, RN University of Nebraska

Publications of Results:
Other Publications:
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Responsible Party: Bunny J. Pozehl, Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT01658670    
Other Study ID Numbers: 608-11-FB
1R01HL112979 ( U.S. NIH Grant/Contract )
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Bunny J. Pozehl, University of Nebraska:
Heart failure
exercise
adherence
quality of life
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
8-chloro-cyclic adenosine monophosphate
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs