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Heart FailureHEARTNCT01658670

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

A study testing HEART Camp (HC) Intervention Group in people with Heart Failure, run by University of Nebraska at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Heart Failure
What is being tested?
HEART Camp (HC) Intervention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
245 participants
Where
3 sitesUnited States
Study dates
1 Apr 2012to 1 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Wayne State University

    Detroit, Michigan, 48202

  • University of Nebraska Medical Center, College of Nursing

    Omaha, Nebraska, 68198-5330

Other trials in United States

About this study

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.

Read the 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.

Conditions
Heart Failure
Being tested
Enhanced Usual Care Group, HEART Camp (HC) Intervention Group
Keywords
Heart failure, exercise, adherence, quality of life
Medical subject headings
Heart Failure, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced Usual Care GroupBehavioural

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

  • HEART Camp (HC) Intervention GroupBehavioural

    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.

Study groups in NCT01658670
Study groupRoleWhat they receive
Enhanced Usual Care (EUC) exercise groupActive comparatorThe EUC group is provided paid access to the exercise facility and has access to regular facility staff for the 18 month study period.
Receives: Behavioral: Enhanced Usual Care Group
HEART Camp (HC) Intervention groupExperimentalThe 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.
Receives: Behavioral: HEART Camp (HC) Intervention Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to exercise.

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

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2012 (estimated)
  2. Study start1 Apr 2012
  3. Primary completion1 Dec 2016
  4. Study completion1 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
245 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01658670
Sponsor's protocol ID
0608-11-FB
Other IDs
1R01HL112979
Acronym
HEART
Status last verified
Nov 2023
First submitted
31 Jul 2012
Last updated
9 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25433674

  • 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.

    PubMed 30010027

  • 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.

    PubMed 29538050

  • 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.

    PubMed 28902683

  • 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.

    PubMed 38597735

  • 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.

    PubMed 34534664

Questions about this trial

What is this clinical trial studying?

A study testing HEART Camp (HC) Intervention Group in people with Heart Failure, run by University of Nebraska at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to exercise. (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01658670, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.

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