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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Nebraska
Sponsor:
Collaborators:
Wayne State University
Henry Ford Health System
University of Nebraska Lincoln
Information provided by (Responsible Party):
Bunny J. Pozehl, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01658670
First received: July 31, 2012
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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 Intervention
Heart Failure
Behavioral: Standard Care Exercise Group
Behavioral: HEART Camp Exercise Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: HEART Camp: Promoting Adherence to Exercise in Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Adherence to exercise. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Ahderence to exercise will also be measured at 6 and 12 months.


Estimated Enrollment: 246
Study Start Date: April 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Care (SC) exercise group
Standard care exercise group
Behavioral: Standard Care Exercise Group
The SC group is provided access to the exercise facility and regular facility staff for the 18 month study period.
Experimental: HEART Camp
HEART Camp Exercise Group
Behavioral: HEART Camp Exercise Group
The HC intervention group will be provided access to the exercise facility for the 18 month study period and will also receive cognitive-behavioral strtegies that address the intervention components of knowledge, attitudes, self-efficacy, behavioral self-management skills and social support.

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 a standard care (SC) 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 SC 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 accelerometry and self-report); 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 (race, gender, age) 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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 less than 3 months ago
  • orthopedic or neuromuscular disorders preventing participation in aerobic exercise and strength/resistance training
  • participation in 3 times per week aerobic exercise during the past 6 months
  • cardiopulmonary stress test results that preclude safe exercise training
  • plans to move more than 50 miles from the exercise site within the next year
  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: NCT01658670

Contacts
Contact: Bunny J Pozehl, PhD, RN 402-472-7352 bpozehl@unmc.edu
Contact: Rita L. McGuire, PdD, RN 402-472-4712 rita.mcguire@unmc.edu

Locations
United States, Michigan
Henry Ford Health System Active, not recruiting
Detroit, Michigan, United States, 48202
Wayne State University Active, not recruiting
Detroit, Michigan, United States, 48202
United States, Nebraska
University of Nebraska Medical Center College of Nursing Recruiting
Lincoln, Nebraska, United States, 68588
Contact: Bunny J Pozehl, PhD,APRN-NP    402-472-7352    bpozehl@unmc.edu   
Principal Investigator: Bunny J Pozehl, PhD, APRN-NP         
University of Nebraska-Lincoln Active, not recruiting
Lincoln, Nebraska, United States, 68508
Sponsors and Collaborators
University of Nebraska
Wayne State University
Henry Ford Health System
University of Nebraska Lincoln
Investigators
Principal Investigator: Bunny J Pozehl, PhD, RN University of Nebraska
  More Information

Publications:
Preacher KJ, Rucker DD, Hayes AF. Addressing Moderated Mediation Hypotheses: Theory, Methods, and Prescriptions. Multivariate Behavioral Research 42(1):185-227, 2007.

Responsible Party: Bunny J. Pozehl, Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT01658670     History of Changes
Other Study ID Numbers: 608-11-FB, 1R01HL112979
Study First Received: July 31, 2012
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Heart failure
exercise
adherence
quality of life

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014