Clinical trial NCT02196038: A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients
Official title: REHAB-HF: A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Decompensated Heart Failure
Keywords: heart failure
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-07-21
Enrollment: 349
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Short Physical Performance Battery (SPPB) at Month 3
timeFrame: Month 3
Secondary outcomes:
measure: All-Cause Rehospitalization
timeFrame: Month 6
Other outcomes:
measure: 6-minute Walk Distance
timeFrame: Month 3
measure: Handgrip Strength
timeFrame: Month 3
measure: Frailty Status (Fried Frailty Criteria) at Month 3
timeFrame: Month 3
measure: Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
timeFrame: Month 3
measure: Physical Limitation as Assessed by the KCCQ Physical Limitation Score
timeFrame: Month 3
measure: Quality of Life Measured by Short Form 12 Item Questionnaire (SF-12)
timeFrame: Month 3
measure: Quality of Life Assessed by the EuroQol 5-dimension 5-level (EQ-5D-5L)
timeFrame: Month 6
measure: Depression Measured by the Geriatric Depression Scale
timeFrame: Month 3
measure: Cognitive Function Measured by the Montreal Cognitive Assessment (MoCA)
timeFrame: Month 3
measure: All-cause Rehospitalizations at Month 1
timeFrame: Month 1
measure: All-cause Rehospitalizations at Month 3
timeFrame: Month 3
measure: All-cause Combined Rehospitalization and Death at Month 6
timeFrame: Month 6
measure: Heart Failure Rehospitalizations at Month 6
timeFrame: Month 6
measure: Hospitalization Days Post-randomization
timeFrame: Month 6
measure: Facility-free Days Alive
timeFrame: Month 6
measure: Emergency Department Visits
timeFrame: Month 6
measure: Observation Unit Stays <24 Hours
timeFrame: Month 6
measure: Unscheduled Urgent Medical Visits
timeFrame: Month 6
measure: Global Rank Score of Short Physical Performance Battery Score + All-cause Rehospitalization + Death
timeFrame: Month 6
measure: Placement at Skilled Nursing Facility
timeFrame: Month 6
measure: Physical Activity Assessed by Accelerometry
timeFrame: Month 6
measure: Generalized Optimism Assessed by the Life Orientation Test-Revised
timeFrame: Month 3
measure: Economic Analysis
timeFrame: Month 6
measure: Biomarkers
timeFrame: Month 3
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University and Hospital
state: Pennsylvania
Study officials:
affiliation: Wake Forest University Health Sciences
name: Dalane W. Kitzman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nelson MB, Shiroma EJ, Kitzman DW, Duncan PW, Reeves GR, Whellan DJ, Mentz RJ, Chen H, Pastva AM. Physical activity and relationship to physical function, quality of life, and cognitive function in older patients with acute decompensated heart failure. Am Heart J. 2023 Feb;256:85-94. doi: 10.1016/j.ahj.2022.11.002. Epub 2022 Nov 11.
citation: Whellan D, McCarey MM, Chen H, Nelson MB, Pastva AM, Duncan P, Mentz RJ, Kitzman DW, Reeves G, Reed SD. Quality of Life Trajectory and Its Mediators in Older Patients With Acute Decompensated Heart Failure Receiving a Multi-Domain Rehabilitation Intervention: Results From the Rehabilitation Therapy in Older Acute Heart Failure Patients Trial. Circ Heart Fail. 2022 Dec;15(12):e009695. doi: 10.1161/CIRCHEARTFAILURE.122.009695. Epub 2022 Nov 8.
citation: Peters AE, Kitzman DW, Chen H, Nelson MB, Pastva AM, Duncan PW, Reeves GR, Upadhya B, Whellan DJ, Mentz RJ. Obesity Status and Physical Rehabilitation in Older Patients Hospitalized With Acute HF: Insights From REHAB-HF. JACC Heart Fail. 2022 Dec;10(12):918-927. doi: 10.1016/j.jchf.2022.07.008. Epub 2022 Sep 7.
citation: Nelson MB, Gilbert ON, Duncan PW, Kitzman DW, Reeves GR, Whellan DJ, Mentz RJ, Chen H, Hewston LA, Taylor KM, Pastva AM. Intervention Adherence in REHAB-HF: Predictors and Relationship With Physical Function, Quality of Life, and Clinical Events. J Am Heart Assoc. 2022 Jun 7;11(11):e024246. doi: 10.1161/JAHA.121.024246. Epub 2022 Jun 3.
citation: Mentz RJ, Whellan DJ, Reeves GR, Pastva AM, Duncan P, Upadhya B, Nelson MB, Chen H, Reed SD, Rosenberg PB, Bertoni AG, O'Connor CM, Kitzman DW. Rehabilitation Intervention in Older Patients With Acute Heart Failure With Preserved Versus Reduced Ejection Fraction. JACC Heart Fail. 2021 Oct;9(10):747-757. doi: 10.1016/j.jchf.2021.05.007. Epub 2021 Jul 7.
citation: Kitzman DW, Whellan DJ, Duncan P, Pastva AM, Mentz RJ, Reeves GR, Nelson MB, Chen H, Upadhya B, Reed SD, Espeland MA, Hewston L, O'Connor CM. Physical Rehabilitation for Older Patients Hospitalized for Heart Failure. N Engl J Med. 2021 Jul 15;385(3):203-216. doi: 10.1056/NEJMoa2026141. Epub 2021 May 16.
citation: Warraich HJ, Kitzman DW, Whellan DJ, Duncan PW, Mentz RJ, Pastva AM, Nelson MB, Upadhya B, Reeves GR. Physical Function, Frailty, Cognition, Depression, and Quality of Life in Hospitalized Adults >/=60 Years With Acute Decompensated Heart Failure With Preserved Versus Reduced Ejection Fraction. Circ Heart Fail. 2018 Nov;11(11):e005254. doi: 10.1161/CIRCHEARTFAILURE.118.005254.
citation: Reeves GR, Whellan DJ, O'Connor CM, Duncan P, Eggebeen JD, Morgan TM, Hewston LA, Pastva A, Patel MJ, Kitzman DW. A Novel Rehabilitation Intervention for Older Patients With Acute Decompensated Heart Failure: The REHAB-HF Pilot Study. JACC Heart Fail. 2017 May;5(5):359-366. doi: 10.1016/j.jchf.2016.12.019. Epub 2017 Mar 8.