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A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients (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.
 
ClinicalTrials.gov Identifier: NCT02196038
Recruitment Status : Completed
First Posted : July 21, 2014
Results First Posted : June 23, 2021
Last Update Posted : June 24, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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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 352 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 349 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
Actual Primary Completion Date : June 15, 2020
Actual Study Completion Date : July 27, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Short Physical Performance Battery (SPPB) at Month 3 [ Time Frame: Month 3 ]
    The Short Physical Performance Battery is scored on a scale of 0-12, with a higher score indicating better physical function.


Secondary Outcome Measures :
  1. All-Cause Rehospitalization [ Time Frame: Month 6 ]
    Number of all-cause rehospitalizations 6 months from index hospital discharge.


Other Outcome Measures:
  1. 6-minute Walk Distance [ Time Frame: Month 3 ]
    Exploratory outcome. Distance walked in 6 minutes.

  2. Handgrip Strength [ Time Frame: Month 3 ]
    Exploratory outcome. Handgrip strength is measured in kilograms by a handgrip dynamometer.

  3. Frailty Status (Fried Frailty Criteria) at Month 3 [ Time Frame: Month 3 ]
    Exploratory outcome. Frailty is assessed by the Fried criteria consisting of 5 components: low physical activity, exhaustion, weakness, slowness, and unintentional weight loss. Presence of 3 or more Fried criteria indicates frailty, 1-2 criteria indicates pre-frailty, and 0 criteria indicates no frailty.

  4. Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score [ Time Frame: Month 3 ]
    Exploratory outcome. The KCCQ Overall Summary Summary Score is a heart failure disease-specific quality of life measure encompassing domains of physical limitation, HF symptoms, quality of life, and social limitation scored on a scale of 0-100 with higher scores indicating better health status.

  5. Physical Limitation as Assessed by the KCCQ Physical Limitation Score [ Time Frame: Month 3 ]
    Exploratory outcome. The Physical Limitation Score of the KCCQ questionnaire is a subscore evaluating disease-specific physical limitation. Scores range 0-100 with a higher score indicating less physical limitation.

  6. Quality of Life Measured by Short Form 12 Item Questionnaire (SF-12) [ Time Frame: Month 3 ]
    Exploratory outcome. The SF-12 is a quality of life assessment with 2 component scores (Physical Composite Score and Mental Composite Score) ranging 0-100 with higher scores indicating better health status.

  7. Quality of Life Assessed by the EuroQol 5-dimension 5-level (EQ-5D-5L) [ Time Frame: Month 6 ]
    Exploratory outcome. The EQ-5D-5L is a quality of life tool with 5 components designed to detect health utilities: mobility, usual activities, self-care, pain/discomfort, and anxiety/depression. All components are rated on a scale of 1-5 with higher scores indicating worse health status.

  8. Depression Measured by the Geriatric Depression Scale [ Time Frame: Month 3 ]
    Exploratory outcome. The Geriatric Depression Scale is a 15-item questionnaire evaluating depressive symptoms. Scores range from 0-15 with a higher score indicating more severe depressive symptoms.

  9. Cognitive Function Measured by the Montreal Cognitive Assessment (MoCA) [ Time Frame: Month 3 ]
    Exploratory outcome. The Montreal Cognitive Assessment is a tool for assessing multiple domains of cognitive function. Scores range 0-30 with higher scores indicating better cognitive function. A score greater than or equal to 26 is considered normal cognitive function.

  10. All-cause Rehospitalizations at Month 1 [ Time Frame: Month 1 ]
    Exploratory outcome. Number of all-cause rehospitalizations 1 month post index hospitalization discharge.

  11. All-cause Rehospitalizations at Month 3 [ Time Frame: Month 3 ]
    Exploratory outcome. Number of all-cause rehospitalizations 3 months after discharged from index hospitalization

  12. All-cause Combined Rehospitalization and Death at Month 6 [ Time Frame: Month 6 ]
    Exploratory outcome. Combined number of all-cause rehospitalizations and death 6 months after discharge from index hospitalization

  13. Heart Failure Rehospitalizations at Month 6 [ Time Frame: Month 6 ]
    Exploratory outcome. Number of heart failure rehospitalizations 6 months after discharge from index hospitalization

  14. Hospitalization Days Post-randomization [ Time Frame: Month 6 ]
    Exploratory outcome. Total days spent hospitalized after date of randomization.

  15. Facility-free Days Alive [ Time Frame: Month 6 ]
    Exploratory outcomes. Total days alive spent outside of hospital, observation unit, acute rehab setting, and skilled nursing facility 6 months after discharge from index hospitalization.

  16. Emergency Department Visits [ Time Frame: Month 6 ]
    Exploratory outcomes. Number of emergency department visits after 6 months from hospital discharge

  17. Observation Unit Stays <24 Hours [ Time Frame: Month 6 ]
    Exploratory outcome. Number of observation unit stays <24 hours 6 months after discharge from index hospitalization

  18. Unscheduled Urgent Medical Visits [ Time Frame: Month 6 ]
    Exploratory outcome. Number of unscheduled urgent medical visits after discharge from index hospitalization

  19. Global Rank Score of Short Physical Performance Battery Score + All-cause Rehospitalization + Death [ Time Frame: Month 6 ]
    Exploratory outcome. The global rank composite outcome combines non-commensurate endpoints including death, number of all-cause rehospitalizations, and month 3 SPPB into a single non-parametric outcome in a hierarchical manner with death being ranked first and SPPB being ranked last. Participants are ranked from the most adverse response (lowest rank) to the most favorable response (highest rank).

  20. Placement at Skilled Nursing Facility [ Time Frame: Month 6 ]
    Exploratory outcome. Number of placements at skilled nursing facilities after discharge from index hospitalization.

  21. Physical Activity Assessed by Accelerometry [ Time Frame: Month 6 ]
    Exploratory outcome. Physical activity assessed by accelerometry quantified in moderate-vigorous physical activity minutes per day.

  22. Generalized Optimism Assessed by the Life Orientation Test-Revised [ Time Frame: Month 3 ]
    Exploratory outcome. The Life Orientation Test-Revised is a assessment of generalized optimism scored on a scale of 0-24 with higher scores indicating higher optimism.

  23. Economic Analysis [ Time Frame: Month 6 ]
    Assess direct medical costs, direct non-medical costs, indirect patient time costs, short-term cost-analysis, long-term cost analysis, and sustainability of the intervention.

  24. Biomarkers [ Time Frame: Month 3 ]
    Two well-accepted biomarkers of HF disease severity and prognosis, NT-proBNP and galectin-3, and increased biomarkers in older HF patients Tumor necrosis factor alpha, C-reactive protein, and interleukin-6.


Eligibility Criteria
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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.


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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
Contacts and Locations
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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
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Thomas Jefferson University and Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Dalane W. Kitzman, MD Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
Study Protocol and Statistical Analysis Plan  [PDF] February 6, 2018
Informed Consent Form  [PDF] February 20, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02196038    
Other Study ID Numbers: IRB00028221
R01AG045551 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2014    Key Record Dates
Results First Posted: June 23, 2021
Last Update Posted: June 24, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Heart Failure
Heart Diseases
Cardiovascular Diseases