HEART Camp: Promoting Adherence to Exercise in Patients With Heart Failure (HEART)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Usual Care Group
HEART Camp (HC) Intervention Group
Sponsored by

About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring Heart failure, exercise, adherence, quality of life
Eligibility 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
Sites / Locations
- Henry Ford Health System
- Wayne State University
- University of Nebraska Medical Center, College of Nursing
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Enhanced Usual Care (EUC) exercise group
HEART Camp (HC) Intervention group
Arm Description
The EUC group is provided paid access to the exercise facility and has access to regular facility staff for the 18 month study period.
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.
Outcomes
Primary Outcome Measures
Adherence to exercise.
Adherence to exercise with 18 months as the primary outcome time point.
Secondary Outcome Measures
Full Information
NCT ID
NCT01658670
First Posted
July 31, 2012
Last Updated
September 21, 2023
Sponsor
University of Nebraska
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Wayne State University, Henry Ford Health System, University of Nebraska Lincoln
1. Study Identification
Unique Protocol Identification Number
NCT01658670
Brief Title
HEART Camp: Promoting Adherence to Exercise in Patients With Heart Failure
Acronym
HEART
Official Title
HEART Camp: Promoting Adherence to Exercise in Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2012 (Actual)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
March 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Wayne State University, Henry Ford Health System, University of Nebraska Lincoln
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
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, quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
245 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced Usual Care (EUC) exercise group
Arm Type
Active Comparator
Arm Description
The EUC group is provided paid access to the exercise facility and has access to regular facility staff for the 18 month study period.
Arm Title
HEART Camp (HC) Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care Group
Intervention Description
The EUC group is provided access to the exercise facility and regular facility staff for the 18 month study period.
Intervention Type
Behavioral
Intervention Name(s)
HEART Camp (HC) Intervention Group
Intervention Description
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 Measure Information:
Title
Adherence to exercise.
Description
Adherence to exercise with 18 months as the primary outcome time point.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bunny J Pozehl, PhD, RN
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of Nebraska Medical Center, College of Nursing
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-5330
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25433674
Citation
Pozehl BJ, Duncan K, Hertzog M, McGuire R, Norman JF, Artinian NT, Keteyian SJ. Study of adherence to exercise in heart failure: the HEART camp trial protocol. BMC Cardiovasc Disord. 2014 Nov 29;14:172. doi: 10.1186/1471-2261-14-172.
Results Reference
background
PubMed Identifier
30010027
Citation
Pozehl BJ, McGuire R, Duncan K, Kupzyk K, Norman J, Artinian NT, Deka P, Krueger SK, Saval MA, Keteyian SJ. Effects of the HEART Camp Trial on Adherence to Exercise in Patients With Heart Failure. J Card Fail. 2018 Oct;24(10):654-660. doi: 10.1016/j.cardfail.2018.06.007. Epub 2018 Aug 16.
Results Reference
result
PubMed Identifier
29538050
Citation
Pozehl BJ, Mcguire R, Duncan K, Hertzog M, Deka P, Norman J, Artinian NT, Saval MA, Keteyian SJ. Accelerometer-Measured Daily Activity Levels and Related Factors in Patients With Heart Failure. J Cardiovasc Nurs. 2018 Jul/Aug;33(4):329-335. doi: 10.1097/JCN.0000000000000464.
Results Reference
result
PubMed Identifier
28902683
Citation
Brawner CA, Ehrman JK, Myers J, Chase P, Vainshelboim B, Farha S, Saval MA, McGuire R, Pozehl B, Keteyian SJ. Exercise Oscillatory Ventilation: Interreviewer Agreement and a Novel Determination. Med Sci Sports Exerc. 2018 Feb;50(2):369-374. doi: 10.1249/MSS.0000000000001423.
Results Reference
result
PubMed Identifier
34534664
Citation
Alonso WW, Kupzyk KA, Norman JF, Lundgren SW, Fisher A, Lindsey ML, Keteyian SJ, Pozehl BJ. The HEART Camp Exercise Intervention Improves Exercise Adherence, Physical Function, and Patient-Reported Outcomes in Adults With Preserved Ejection Fraction Heart Failure. J Card Fail. 2022 Mar;28(3):431-442. doi: 10.1016/j.cardfail.2021.09.003. Epub 2021 Sep 15.
Results Reference
derived
Learn more about this trial
HEART Camp: Promoting Adherence to Exercise in Patients With Heart Failure
We'll reach out to this number within 24 hrs