Rehabilitation and Exercise Training After Hospitalization

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: Rehabilitation intervention; Behavioral: Usual care

• Registration Number: NCT01508650
• Lead Sponsor: Wake Forest University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-12-21
• Study First Submitted QC: 2012-01-11
• Study First Posted: 2012-01-12
• Primary Completion: 2012-06-08
• Study Completion: 2012-09-07
• Results First Submitted: 2018-01-26
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-21
• Last Update Submitted: 2018-09-21
• Results First Posted: 2019-02-07
• Last Update Posted: 2019-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator	Rehabilitation intervention	Multi domain rehabilitation intervention
No intervention	Usual care	Usual care control group

Primary Outcome Measures

Name	Time	Method
6 Minute Walk Test	up to 3 months	The 6 minute walk test submaximal exercise test that measures how far a participant can walk in 6 continuous minutes. Participants are instructed to walk as far as possible in 6 minutes, and are allowed to slow down and take breaks as needed due to symptoms.

Secondary Outcome Measures

Name	Time	Method
SPPB (Short Physical Performance Battery)	up to 3 months	The SPPB is a multi-component measure of physical function. The SPPB is composed of 3 components-standing balance, gait speed, and timed repeated chair rise-each scored on a scale from 0 to 4 and combined for a total score of 0 to 12. A higher score denotes better physical function.

Trial Locations

Locations (3)

Wake Forest Baptist Hospital; 🇺🇸 Winston-Salem, North Carolina, United States

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Duke Medical Center; 🇺🇸 Durham, North Carolina, United States