Rehabilitation and Exercise Training After Hospitalization (REHAB-HF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Wake Forest School of Medicine
Sponsor:
Information provided by (Responsible Party):
Dalane W. Kitzman, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01508650
First received: December 21, 2011
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Heart Failure
Behavioral: Usual care
Behavioral: Rehabilitation intervention
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rehabilitation and Exercise Training After Hospitalization: Assessing Benefit in Acute Heart Failure (REHAB-HF) Pilot Study

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • 6 minute walk test [ Time Frame: At baseline, and 3 month visits. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SPPB [ Time Frame: At baseline, and 3 month visits. ] [ Designated as safety issue: No ]
    (short physical performance battery)4 meter walk, chair rise, and standing balance.


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508650

Contacts
Contact: Joel Eggebeen, MS 336-716-6967 jeggebee@wakehealth.edu
Contact: Dalane W Kitzman, MD 336-716-3274 dkitzman@wakehealth.edu

Locations
United States, North Carolina
Duke Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Christopher O'Connor, MD    919-681-6195    christophe.oconnor@duke.edu   
Contact: Patti Adams, RN    919 668 8222    patricia.adams@duke.edu   
Principal Investigator: Christopher O'Connor, MD         
Wake Forest Baptist Hospital Recruiting
Winston Salem, North Carolina, United States, 27157
Principal Investigator: Dalane W Kitzman, MD         
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: David J Whellan, MD    215-955-2050    djw150@jefferson.edu   
Contact: Suzanne Adams, RN    215 955 8848    suzanne.adams@jefferson.edu   
Principal Investigator: David J Whellan, MD         
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Dalane W Kitzman, MD Wake Forest Baptist Hospital
  More Information

No publications provided

Responsible Party: Dalane W. Kitzman, Professor Internal Medicine Cardiology/Gerontology, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01508650     History of Changes
Other Study ID Numbers: IRB00016973
Study First Received: December 21, 2011
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014