A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients

Acute Decompensated Heart Failure Clinical Trial

— REHAB-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196038
• Other study ID #: IRB00028221
• Secondary ID: R01AG045551
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: July 27, 2020

Study information

• Verified date: September 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: July 27, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Intervention

Behavioral:
• multi-domain rehabilitation intervention
Individual, tailored, progressive physical function rehabilitation intervention
• Attention Control
Usual care with bi-weekly contact from study staff

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Thomas Jefferson University and Hospital	Philadelphia	Pennsylvania
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	6-minute Walk Distance	Exploratory outcome. Distance walked in 6 minutes.	Month 3
Other	Handgrip Strength	Exploratory outcome. Handgrip strength is measured in kilograms by a handgrip dynamometer.	Month 3
Other	Frailty Status (Fried Frailty Criteria) at 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.	Month 3
Other	Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score	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.	Month 3
Other	Physical Limitation as Assessed by the KCCQ Physical Limitation Score	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.	Month 3
Other	Quality of Life Measured by Short Form 12 Item Questionnaire (SF-12)	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.	Month 3
Other	Quality of Life Assessed by the EuroQol 5-dimension 5-level (EQ-5D-5L)	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.	Month 6
Other	Depression Measured by the Geriatric Depression Scale	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.	Month 3
Other	Cognitive Function Measured by the Montreal Cognitive Assessment (MoCA)	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.	Month 3
Other	All-cause Rehospitalizations at Month 1	Exploratory outcome. Number of all-cause rehospitalizations 1 month post index hospitalization discharge.	Month 1
Other	All-cause Rehospitalizations at Month 3	Exploratory outcome. Number of all-cause rehospitalizations 3 months after discharged from index hospitalization	Month 3
Other	All-cause Combined Rehospitalization and Death at Month 6	Exploratory outcome. Combined number of all-cause rehospitalizations and death 6 months after discharge from index hospitalization	Month 6
Other	Heart Failure Rehospitalizations at Month 6	Exploratory outcome. Number of heart failure rehospitalizations 6 months after discharge from index hospitalization	Month 6
Other	Hospitalization Days Post-randomization	Exploratory outcome. Total days spent hospitalized after date of randomization.	Month 6
Other	Facility-free Days Alive	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.	Month 6
Other	Emergency Department Visits	Exploratory outcomes. Number of emergency department visits after 6 months from hospital discharge	Month 6
Other	Observation Unit Stays <24 Hours	Exploratory outcome. Number of observation unit stays <24 hours 6 months after discharge from index hospitalization	Month 6
Other	Unscheduled Urgent Medical Visits	Exploratory outcome. Number of unscheduled urgent medical visits after discharge from index hospitalization	Month 6
Other	Global Rank Score of Short Physical Performance Battery Score + All-cause Rehospitalization + Death	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).	Month 6
Other	Placement at Skilled Nursing Facility	Exploratory outcome. Number of placements at skilled nursing facilities after discharge from index hospitalization.	Month 6
Other	Physical Activity Assessed by Accelerometry	Exploratory outcome. Physical activity assessed by accelerometry quantified in moderate-vigorous physical activity minutes per day.	Month 6
Other	Generalized Optimism Assessed by the Life Orientation Test-Revised	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.	Month 3
Other	Economic Analysis	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.	Month 6
Other	Biomarkers	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.	Month 3
Primary	Short Physical Performance Battery (SPPB) at Month 3	The Short Physical Performance Battery is scored on a scale of 0-12, with a higher score indicating better physical function.	Month 3
Secondary	All-Cause Rehospitalization	Number of all-cause rehospitalizations 6 months from index hospital discharge.	Month 6