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A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF)

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ClinicalTrials.gov Identifier: NCT02196038
Recruitment Status : Recruiting
First Posted : July 21, 2014
Last Update Posted : July 16, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
REHAB-HF: A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients, is a multicenter, randomized, attention-controlled, single-blind trial designed to examine the hypothesis that, in addition to standard care, a novel, tailored, progressive, multi-domain rehabilitation intervention administered to older patients with acute decompensated heart failure (ADHF) beginning early during hospitalization and continuing for 12 weeks will improve physical function and key clinical outcomes, including the rate of rehospitalization.

Condition or disease Intervention/treatment Phase
Acute Decompensated Heart Failure Behavioral: multi-domain rehabilitation intervention Behavioral: Attention Control Not Applicable

Detailed Description:
There will be three lead centers, Wake Forest Baptist Health along with Thomas Jefferson University and Hospital-Co-Investigator Dr. David Whellan, and Duke University Medical Center-Co-Investigator Dr. Christopher O'Connor. Each center may recruit up to 3 geographically close, tightly affiliated 'satellite' sites under their management and budgetary control. Together, these sites will recruit a total of 360 consenting patients ≥ 60 years old hospitalized with ADHF. Following informed consent and baseline testing, the participants will be randomized in a 1:1 fashion to receive a 12-week novel, progressive, multi-domain rehabilitation and exercise training intervention or attention control. The multi-domain rehabilitation intervention will include endurance, mobility, strength, and balance training and will be tailored based on participant performance in each of these domains. It will begin upon randomization during the hospitalization and will continue 3 times per week in an outpatient setting. Participants randomized to the attention control arm will receive all services ordered by their primary physician and will be contacted bi-weekly by study staff. All participants will undergo measures of physical function and quality of life at baseline, 1 month, and 3 months. Clinical events will be monitored for 6 months following the index hospitalization.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: REHAB-HF: A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients
Study Start Date : September 2014
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Attention Control
Usual care group with bi-weekly contact from study staff
Behavioral: Attention Control
Usual care with bi-weekly contact from study staff

Active Comparator: multi-domain rehabilitation intervention
Individual, tailored, progressive, physical function rehabilitation intervention
Behavioral: multi-domain rehabilitation intervention
Individual, tailored, progressive physical function rehabilitation intervention




Primary Outcome Measures :
  1. Change in Short Physical Performance Battery (SPPB) [ Time Frame: Baseline and 3 months ]

Secondary Outcome Measures :
  1. All-Cause rehospitalization [ Time Frame: 6 months from index hospital discharge ]

Other Outcome Measures:
  1. Economic Analysis [ Time Frame: 6-months ]
    Assess the economic impact of the intervention by comparing medical costs between treatment arms, inclusive of the cost for rehabilitation therapy, relative to its associated changes in health outcomes.



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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
  • In the hospital setting >24 hours for the management of ADHF, or diagnosed with ADHF after being hospitalized for another reason. ADHF will be confirmed by the study physician, and will be defined according to the Food and Drug Administration definition of hospitalized heart failure as a combination of symptoms, signs, and HF-specific medical treatments.

Exclusion Criteria:

  • Acute myocardial infarction
  • Planned discharge other than to home or a facility where the participant will live independently
  • Already actively participating in formal, facility-based 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): NCT02196038


Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Patti Adams, RN    919-668-8222    patricia.adams@duke.edu   
Principal Investigator: Christopher O'Connor, MD         
Sub-Investigator: Mahesh Patel, MD         
Sub-Investigator: Shelby Reed, PhD         
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Ben Nelson, MS    336-716-6789    bnelson@wakehealth.edu   
Contact: Kathy Stewart    336-716-6339    kstewart@wakehealth.edu   
Principal Investigator: Dalane W. Kitzman, MD         
United States, Pennsylvania
Thomas Jefferson University and Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Suzanne Adams, RN, MPH    215-955-8848    suzanne.adams@jefferson.edu   
Contact: Lauren Trinsey, MS    215-503-4069    lauren.trinsey@jefferson.edu   
Principal Investigator: David J. Whellan, MD, MHS         
Sub-Investigator: Gordon R. Reeves, MD, MPT         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute on Aging (NIA)
Investigators
Principal Investigator: Dalane W. Kitzman, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02196038     History of Changes
Other Study ID Numbers: IRB00028221
R01AG045551 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases