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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
University of Nebraska
Study ID
NCT05784753
Status
Recruiting
Apply to this trial

Conditions

  • HFpEF - Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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 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).

Study Details

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.

Key Dates

Start date
Nov 20, 2023
Status verified
Jan 2026
Primary completion
Feb 29, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HEART Camp
    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.
  • Experimental: HEART Camp Connect
    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.
  • No Intervention: Enhanced Usual Care
    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.

Primary Outcome Measure

Exercise Adherence [ Time Frame: 6 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Henry Ford Health SystemDetroitMichigan49201
Steven Keteyian, PhD
[email protected]
Crystal Grimshaw
[email protected]
University of Nebraska Medical CenterOmahaNebraska68198-5330
Bunny Pozehl, PhD, RN
[email protected]
402-559-8342
Tiffany Dudley
[email protected]
University of VirginiaCharlottesvilleVirginia22903
Windy Alonso, PhD, RN
[email protected]
Souad Benloukil
[email protected]

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By research site
Henry Ford Health System· Detroit, MIUniversity of Nebraska Medical Center· Omaha, NEUniversity of Virginia· Charlottesville, VA

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