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Completed

NCT Number: NCT02196038

A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center, Durham, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multi-domain rehabilitation intervention

Behavioral

Individual, tailored, progressive physical function rehabilitation intervention

Attention Control

Behavioral

Usual care with bi-weekly contact from study staff

Primary outcomes

  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 outcomes

  1. All-Cause Rehospitalization

    Time frame: Month 6

    Number of all-cause rehospitalizations 6 months from index hospital discharge.

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: REHAB-HF

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Jul 21, 2014
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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