HEART Camp Connect -Promoting Exercise in Adults With Heart Failure With Preserved Ejection Fraction

NCT05784753 | Recruiting DMC

• 1 other identifier: 0040-23-FB
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this study is to learn more about patients with heart failure with preserved ejection fraction (HFpEF) and exercise. Investigators want to see if meeting with a coach in person or by video conference will help these patients exercise, feel better, and change markers in their blood. Participants will be randomly placed in one of three groups for 18 months. All groups will have access to a fitness center and be given a watch and heart rate monitor to wear during exercise. The usual care group (control group) will have access to exercise videos via the medical fitness center and will not meet with a coach. The HEART Camp group will exercise and meet with their coach in-person at the medical fitness center. The HEART Camp Connect group will have access to exercise videos via the medical fitness center and will meet with their coach via videoconferencing. All participants will take part in an exercise test and study training prior to being randomized. At four data collection time points, participants will wear an activity monitor for 7 days each, have their blood drawn, and answer questions related to heart failure and exercise. Participants will also wear a heart rate monitor when they exercise and fill out a daily exercise diary.

Conditions

HFpEF - Heart Failure With Preserved Ejection Fraction

Keywords

exercise training; patient adherence; coaching

Outcome Measures

Primary Outcomes (3)

• Exercise Adherence

  Adherence is measured as weekly minutes of moderate intensity exercise as measured by a watch and heart rate sensor.

  6 months

• Exercise Adherence

  Adherence is measured as weekly minutes of moderate intensity exercise as measured by a watch and heart rate sensor.

  12 months

• Exercise Adherence

  Adherence is measured as weekly minutes of moderate intensity exercise as measured by a watch and heart rate sensor.

  18 months

Secondary Outcomes (38)

• HF-related Health Status

  Baseline

• HF-related Health Status

  6 months

• HF-related Health Status

  12 months

• HF-related Health Status

  18 months

• Physical Function

  Baseline

Other Outcomes (44)

• Self-Efficacy

  Baseline

• Self-Efficacy

  6 months

• Self-Efficacy

  12 months

Study Arms (3)

HEART Camp

EXPERIMENTAL

Participants in the HEART Camp group will be provided paid, in-person access to the medical fitness center and in-person coaching by a trained coach.

Behavioral: HEART Camp

HEART Camp Connect

EXPERIMENTAL

Participants in the HEART Camp Connect group will be provided paid, virtual access to the medical fitness center and virtual coaching by a trained coach via videoconference. Participants will also receive automated, asynchronous motivational electronic messaging if they are below the weekly adherence threshold.

Behavioral: HEART Camp Connect

Enhanced Usual Care

NO INTERVENTION

Participants in the Enhanced Usual Care group will be provided paid virtual access to the medical fitness center and virtual availability of the medical fitness center staff and study personnel for participant-initiated questions.

Interventions

HEART Camp BEHAVIORAL

Participants will meet with an in-person coach at the medical fitness center: Months 1-3 weekly for 30 minutes; Months 4-12 every other week for 15 minutes (on alternate weeks, participants will attend a 1-hour group-based exercise training and coaching).

HEART Camp

HEART Camp Connect BEHAVIORAL

Participants will meet with a virtual coach from the medical fitness center via videoconferencing: Months 1-3 weekly for 30 minutes; Months 4-12 every other week for 15 minutes (on alternate weeks, participants will attend a virtual 1-hour group-based exercise training and coaching session via videoconferencing).

HEART Camp Connect

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of heart failure with an ejection fraction greater than or equal to 50
• Echocardiogram in prior 24 months
• Stable pharmacologic therapy in the past 30 days
• Any of the following evidence to confirm HFpEF - Score\< 6 on Heavy Hypertensive Atrial Fibrillation, Pulmonary Hypertension, Elder, Filling Pressure algorithm, invasive hemodynamic evidence of HFpEF(i.e., elevated pulmonary wedge pressure), or a confirmed clinical diagnosis of HFpEF

You may not qualify if:

• Life-limiting illness precluding study completion
• Clinical evidence of decompensated heart failure
• Unstable angina or marked shortness of breath on exertion at less than 2 metabolic equivalents
• Myocardial infarction, coronary artery bypass graft, or biventricular pacemaker in prior 6 weeks
• Orthopedic or neuromuscular disorders preventing aerobic exercise
• Cardiopulmonary exercise test results that preclude safe exercise
• Unwilling/unable to complete pre-randomization procedures
• Pregnancy
• Implantable cardioverter defibrillator

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (3)

Henry Ford Health System

Detroit, Michigan, 49201, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198-5330, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

NOT YET RECRUITING

Related Publications (12)

• Shah SJ, Borlaug BA, Kitzman DW, McCulloch AD, Blaxall BC, Agarwal R, Chirinos JA, Collins S, Deo RC, Gladwin MT, Granzier H, Hummel SL, Kass DA, Redfield MM, Sam F, Wang TJ, Desvigne-Nickens P, Adhikari BB. Research Priorities for Heart Failure With Preserved Ejection Fraction: National Heart, Lung, and Blood Institute Working Group Summary. Circulation. 2020 Mar 24;141(12):1001-1026. doi: 10.1161/CIRCULATIONAHA.119.041886. Epub 2020 Mar 23.

  PMID: 32202936 BACKGROUND

• Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Cheng S, Delling FN, Elkind MSV, Evenson KR, Ferguson JF, Gupta DK, Khan SS, Kissela BM, Knutson KL, Lee CD, Lewis TT, Liu J, Loop MS, Lutsey PL, Ma J, Mackey J, Martin SS, Matchar DB, Mussolino ME, Navaneethan SD, Perak AM, Roth GA, Samad Z, Satou GM, Schroeder EB, Shah SH, Shay CM, Stokes A, VanWagner LB, Wang NY, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2021 Update: A Report From the American Heart Association. Circulation. 2021 Feb 23;143(8):e254-e743. doi: 10.1161/CIR.0000000000000950. Epub 2021 Jan 27.

  PMID: 33501848 BACKGROUND

• McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. No abstract available.

  PMID: 22611136 BACKGROUND

• Fleg JL, Cooper LS, Borlaug BA, Haykowsky MJ, Kraus WE, Levine BD, Pfeffer MA, Pina IL, Poole DC, Reeves GR, Whellan DJ, Kitzman DW; National Heart, Lung, and Blood Institute Working Group. Exercise training as therapy for heart failure: current status and future directions. Circ Heart Fail. 2015 Jan;8(1):209-20. doi: 10.1161/CIRCHEARTFAILURE.113.001420. No abstract available.

  PMID: 25605639 BACKGROUND

• Pandey A, Parashar A, Kumbhani D, Agarwal S, Garg J, Kitzman D, Levine B, Drazner M, Berry J. Exercise training in patients with heart failure and preserved ejection fraction: meta-analysis of randomized control trials. Circ Heart Fail. 2015 Jan;8(1):33-40. doi: 10.1161/CIRCHEARTFAILURE.114.001615. Epub 2014 Nov 16.

  PMID: 25399909 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.

  PMID: 25433674 BACKGROUND

• 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: 30010027 BACKGROUND

• Warehime S, Dinkel D, Alonso W, Pozehl B. Long-term exercise adherence in patients with heart failure: A qualitative study. Heart Lung. 2020 Nov-Dec;49(6):696-701. doi: 10.1016/j.hrtlng.2020.08.016. Epub 2020 Aug 27.

  PMID: 32861888 BACKGROUND

• Alonso WW, Kupzyk K, Norman J, Bills SE, Bosak K, Dunn SL, Deka P, Pozehl B. Negative Attitudes, Self-efficacy, and Relapse Management Mediate Long-Term Adherence to Exercise in Patients With Heart Failure. Ann Behav Med. 2021 Oct 4;55(10):1031-1041. doi: 10.1093/abm/kaab002.

  PMID: 33580663 BACKGROUND

• Norman JF, Kupzyk KA, Artinian NT, Keteyian SJ, Alonso WS, Bills SE, Pozehl BJ. The influence of the HEART Camp intervention on physical function, health-related quality of life, depression, anxiety and fatigue in patients with heart failure. Eur J Cardiovasc Nurs. 2020 Jan;19(1):64-73. doi: 10.1177/1474515119867444. Epub 2019 Aug 2.

  PMID: 31373222 BACKGROUND

• Keteyian SJ. Exercise training in congestive heart failure: risks and benefits. Prog Cardiovasc Dis. 2011 May-Jun;53(6):419-28. doi: 10.1016/j.pcad.2011.02.005.

  PMID: 21545928 BACKGROUND

• 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: 29538050 BACKGROUND

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Windy W Alonso, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Bunny Pozehl, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Windy W Alonso, PhD

CONTACT

402-559-8342; windy.alonso@unmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded study personnel will participate in all data collection time points, meeting with participants at four time points during the study and confirming completeness of questionnaires.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized following a 2-2-1 (HEART Camp Connect - HEART Camp - Enhanced Usual Care) scheme to fully examine comparative effects between virtual and in-person treatment groups.

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 27, 2023
• Study Start: November 20, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available beginning 9 months after the publication of primary outcome results.
• Access Criteria: Researchers that desire access to data from this study will be required to provide a methodologically sound proposal and comply with the standards outlined in the NHLBI data repository.

Locations

US (3)