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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL112979 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Wayne State University | OTHER |
| Henry Ford Health System | OTHER |
| University of Nebraska Lincoln |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Usual Care (EUC) exercise group | Active Comparator | The EUC group is provided paid access to the exercise facility and has access to regular facility staff for the 18 month study period. |
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| HEART Camp (HC) Intervention group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Usual Care Group | Behavioral | The EUC group is provided access to the exercise facility and regular facility staff for the 18 month study period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adherence to exercise. | Adherence to exercise with 18 months as the primary outcome time point. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bunny J Pozehl, PhD, RN | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States | ||
| Wayne State University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25433674 | Background | 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. | |
| 30010027 | Result | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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| OTHER |
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| HEART Camp (HC) Intervention Group | Behavioral | 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. |
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| Detroit |
| Michigan |
| 48202 |
| United States |
| University of Nebraska Medical Center, College of Nursing | Omaha | Nebraska | 68198-5330 | United States |
| 29538050 | Result | 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. |
| 28902683 | Result | 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. |
| 38597735 | Derived | Salahshurian E, Pozehl BJ, Lundgren SW, Bills S, Pandey A, Carbone S, Alonso WW. 'Working me to life': longitudinal perceptions from adults with heart failure with preserved ejection fraction enrolled in an exercise training clinical trial. Eur J Cardiovasc Nurs. 2024 Oct 21;23(7):763-770. doi: 10.1093/eurjcn/zvae049. |
| 34534664 | Derived | 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. |