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Trial record 1 of 1 for:    NCT01508650
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Rehabilitation and Exercise Training After Hospitalization (REHAB-HF)

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ClinicalTrials.gov Identifier: NCT01508650
Recruitment Status : Completed
First Posted : January 12, 2012
Results First Posted : February 7, 2019
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( 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.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Usual care Behavioral: Rehabilitation intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rehabilitation and Exercise Training After Hospitalization: Assessing Benefit in Acute Heart Failure (REHAB-HF) Pilot Study
Study Start Date : October 2011
Actual Primary Completion Date : June 8, 2012
Actual Study Completion Date : September 7, 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: No intervention
Usual care control group
Behavioral: Usual care
Usual care control group

Active Comparator: Active Comparator
Multi domain rehabilitation intervention
Behavioral: Rehabilitation intervention
Multi-domain rehabilitation intervention




Primary Outcome Measures :
  1. 6 Minute Walk Test [ Time Frame: 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 :
  1. SPPB (Short Physical Performance Battery) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508650


Locations
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United States, North Carolina
Duke Medical Center
Durham, North Carolina, United States, 27710
Wake Forest Baptist Hospital
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wake Forest University
Investigators
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Principal Investigator: Dalane W Kitzman, MD Wake Forest Baptist Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT01508650     History of Changes
Other Study ID Numbers: IRB00016973
First Posted: January 12, 2012    Key Record Dates
Results First Posted: February 7, 2019
Last Update Posted: February 7, 2019
Last Verified: September 2018
Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
heart failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases