Rehabilitation and Exercise Training After Hospitalization (REHAB-HF)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual care
Rehabilitation intervention
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring heart failure
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
Sites / Locations
- Duke Medical Center
- Wake Forest Baptist Hospital
- Thomas Jefferson University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
No intervention
Active Comparator
Arm Description
Usual care control group
Multi domain rehabilitation intervention
Outcomes
Primary Outcome Measures
6 Minute Walk Test
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
SPPB (Short Physical Performance Battery)
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.
Full Information
NCT ID
NCT01508650
First Posted
December 21, 2011
Last Updated
September 21, 2018
Sponsor
Wake Forest University
1. Study Identification
Unique Protocol Identification Number
NCT01508650
Brief Title
Rehabilitation and Exercise Training After Hospitalization
Acronym
REHAB-HF
Official Title
Rehabilitation and Exercise Training After Hospitalization: Assessing Benefit in Acute Heart Failure (REHAB-HF) Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 8, 2012 (Actual)
Study Completion Date
September 7, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No intervention
Arm Type
Active Comparator
Arm Description
Usual care control group
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Multi domain rehabilitation intervention
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Usual care control group
Intervention Type
Behavioral
Intervention Name(s)
Rehabilitation intervention
Intervention Description
Multi-domain rehabilitation intervention
Primary Outcome Measure Information:
Title
6 Minute Walk Test
Description
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.
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
SPPB (Short Physical Performance Battery)
Description
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.
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalane W Kitzman, MD
Organizational Affiliation
Wake Forest Baptist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest Baptist Hospital
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28285121
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.
Results Reference
derived
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Rehabilitation and Exercise Training After Hospitalization
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