Rehabilitation and Exercise Training After Hospitalization (REHAB-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01508650
Recruitment Status : Completed
First Posted : January 12, 2012
Last Update Posted : January 18, 2018
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.

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

U.S. FDA Resources

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: At baseline, and 3 month visits. ]

Secondary Outcome Measures :
  1. SPPB(short physical performance battery) [ Time Frame: At baseline, and 3 month visits. ]
    (short physical performance battery)4 meter walk, chair rise, and standing balance.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT01508650

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
Principal Investigator: Dalane W Kitzman, MD Wake Forest Baptist Hospital

Responsible Party: Wake Forest University Identifier: NCT01508650     History of Changes
Other Study ID Numbers: IRB00016973
First Posted: January 12, 2012    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2017

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases