Physical Rehabilitation for Older Patients With Acute Heart Failure With Preserved Ejection Fraction

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05525663
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rehabilitation Intervention — BEHAVIORAL
    progressive, multi-domain rehabilitation and exercise training intervention

Study Details

The REHAB-HFpEF trial will determine whether a novel physical rehabilitation intervention will improve the primary outcome of combined all-cause rehospitalizations and mortality and the secondary outcome of major mobility disability during 6-month follow-up in patients hospitalized for heart failure and preserved ejection fraction (HFpEF), which is nearly unique to older persons, and for which there are few treatment options.

Key Dates

Start date
Feb 16, 2023
Status verified
Jun 2025
Primary completion
Nov 30, 2027
Completion
Jan 31, 2028

Study Design

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

Arms

  • Experimental: Rehabilitation Intervention
    The Rehabilitation Intervention is a novel, progressive, multi-domain rehabilitation and exercise training intervention. The intervention will include strength, balance, endurance, and mobility training and the specific training exercises will be tailored based on participant performance in each of these domains. The intervention will begin as soon as possible after randomization during the hospitalization and will continue 3 times per week in an outpatient setting for 12 weeks.
  • No Intervention: Attention Control
    Attention control participants are contacted bi-weekly by study staff to maintain contact, collect information regarding health status, clinical events, and physical activity/exercise, and ensure retention; they do not receive any specific exercise recommendations.

Primary Outcome Measure

Combined All-cause Rehospitalization and Death [ Time Frame: Month 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157
Dalane W Kitzman, MD
[email protected]
336-716-3274
Michael B Nelson, MS
[email protected]
336-716-6789

Find similar trials in Winston-Salem, NC

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Atrium Health Wake Forest Baptist· Winston-Salem, NC

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