Overview

This trial is active, not recruiting.

Condition heart failure
Treatments usual care, rehabilitation intervention
Phase phase 0
Sponsor Wake Forest University
Start date October 2011
End date December 2016
Trial size 27 participants
Trial identifier NCT01508650, IRB00016973

Summary

Rehabilitation and Exercise Training after Hospitalization: Assessing Benefit in Acute Heart Failure (REHAB-HF) pilot is a multi-site, randomized clinical pilot study designed to establish the feasibility of conducting a larger clinical trial to address the hypothesis that, in addition to standard care, a novel, progressive, multi-domain 3-month rehabilitation intervention administered to elderly patients with acute decompensated heart failure (ADHF) will improve key clinical outcomes, including the rate of rehospitalization and death, physical function, and quality of life.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Usual care control group
usual care
Usual care control group
(Active Comparator)
Multi domain rehabilitation intervention
rehabilitation intervention
Multi-domain rehabilitation intervention

Primary Outcomes

Measure
6 minute walk test
time frame: At baseline, and 3 month visits.

Secondary Outcomes

Measure
SPPB
time frame: At baseline, and 3 month visits.

Eligibility Criteria

Male or female participants at least 60 years old.

Inclusion Criteria: - Age ≥ 60 years old - Hospitalized for the management of ADHF or diagnosed with ADHF after being hospitalized for another reason. ADHF will be defined as a combination of symptoms, signs, and HF-specific medical treatments. Exclusion Criteria: - Planned discharge other than to home or a facility where the participant will live independently. - Acute myocardial infarction - Already participating in cardiac rehabilitation

Additional Information

Official title Rehabilitation and Exercise Training After Hospitalization: Assessing Benefit in Acute Heart Failure (REHAB-HF) Pilot Study
Principal investigator Dalane W Kitzman, MD
Description Three centers,Wake Forest Baptist Health along with Thomas Jefferson University Hospital-Co-Investigator Dr. David Whellan, and Duke Medical Center- Co-Investigator Dr. Christopher O'Connor, will recruit a total of 60 consenting patients ≥ 60 years old hospitalized with ADHF. Once identified and screened, the participants will be randomized in a 1:1 fashion to receive a 3 month novel rehabilitation and exercise training intervention or usual care. This multi-domain intervention will include endurance, mobility, strength, and balance training and be tailored based on participant performance in each of these domains. It will begin during the hospitalization and continue three times per week in an outpatient facility.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Wake Forest School of Medicine.