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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

245

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline

Completed

Started Apr 2012

Longer than P75 for not_applicable heart-failure

Geographic Reach

1 country

3 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.9 years study duration

Study Start

First participant enrolled

April 1, 2012

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2012

Completed

7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed

4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed

Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

4.7 years

First QC Date

July 31, 2012

Last Update Submit

November 7, 2023

Conditions

Heart Failure

Keywords

Heart failureexerciseadherencequality of life

Outcome Measures

Primary Outcomes (1)

Adherence to exercise.
Adherence to exercise with 18 months as the primary outcome time point.
18 months

Study Arms (2)

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.

Behavioral: Enhanced Usual Care Group

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.

Behavioral: HEART Camp (HC) Intervention Group

Interventions

Enhanced Usual Care GroupBEHAVIORAL

The EUC group is provided access to the exercise facility and regular facility staff for the 18 month study period.

Enhanced Usual Care (EUC) exercise group

HEART Camp (HC) Intervention GroupBEHAVIORAL

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.

HEART Camp (HC) Intervention group

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of Nebraskalead
National Heart, Lung, and Blood Institute (NHLBI)collaborator
Wayne State Universitycollaborator
Henry Ford Health Systemcollaborator
University of Nebraska Lincolncollaborator

Study Sites (3)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Wayne State University

Detroit, Michigan, 48202, United States

Location

University of Nebraska Medical Center, College of Nursing

Omaha, Nebraska, 68198-5330, United States

Location

Related Publications (6)

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.
PMID: 25433674BACKGROUND
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.
PMID: 30010027RESULT
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.
PMID: 29538050RESULT
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.
PMID: 28902683RESULT
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.
PMID: 38597735DERIVED
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.
PMID: 34534664DERIVED

MeSH Terms

Conditions

Heart FailureMotor Activity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavior

Study Officials

Bunny J Pozehl, PhD, RN
University of Nebraska
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 31, 2012

First Posted

August 7, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2016

Study Completion

March 1, 2018

Last Updated

November 9, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing: Will not share

Locations

US(3)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Enhanced Usual Care (EUC) exercise group

HEART Camp (HC) Intervention group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations