Clinical trial NCT01508650: Rehabilitation and Exercise Training After Hospitalization
Official title: Rehabilitation and Exercise Training After Hospitalization: Assessing Benefit in Acute Heart Failure (REHAB-HF) Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2012-01-12
Enrollment: 27
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 6 Minute Walk Test
timeFrame: up to 3 months
Secondary outcomes:
measure: SPPB (Short Physical Performance Battery)
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Hospital
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Wake Forest Baptist Hospital
name: Dalane W Kitzman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reeves GR, Whellan DJ, O'Connor CM, Duncan P, Eggebeen JD, Morgan TM, Hewston LA, Pastva A, Patel MJ, Kitzman DW. A Novel Rehabilitation Intervention for Older Patients With Acute Decompensated Heart Failure: The REHAB-HF Pilot Study. JACC Heart Fail. 2017 May;5(5):359-366. doi: 10.1016/j.jchf.2016.12.019. Epub 2017 Mar 8.