A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 2/17/2019 |
| Start Date: | September 2014 |
| End Date: | November 2020 |
REHAB-HF: 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.
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.
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.
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.
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
We found this trial at
3
sites
Winston-Salem, North Carolina 27157
Principal Investigator: Dalane W. Kitzman, MD
Phone: 336-716-6789
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2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Christopher O'Connor, MD
Phone: 919-668-8222
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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111 S 11th St
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: David J. Whellan, MD, MHS
Phone: 215-955-8848
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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