NCT02196038

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
349

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2020

Completed
11 months until next milestone

Results Posted

Study results publicly available

June 23, 2021

Completed
Last Updated

June 24, 2021

Status Verified

September 1, 2020

Enrollment Period

5.8 years

First QC Date

July 15, 2014

Results QC Date

May 28, 2021

Last Update Submit

June 22, 2021

Conditions

Acute Decompensated Heart Failure

Keywords

heart failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • All-Cause Rehospitalization

    Month 6

Other Outcomes (24)

  • 6-minute Walk Distance

    Month 3

  • Handgrip Strength

    Month 3

  • Frailty Status (Fried Frailty Criteria) at Month 3

    Month 3

  • +21 more other outcomes

Study Arms (2)

Attention Control

OTHER

Usual care group with bi-weekly contact from study staff

Behavioral: Attention Control

multi-domain rehabilitation intervention

ACTIVE COMPARATOR

Individual, tailored, progressive, physical function rehabilitation intervention

Behavioral: multi-domain rehabilitation intervention

Interventions

multi-domain rehabilitation interventionBEHAVIORAL

Individual, tailored, progressive physical function rehabilitation intervention

multi-domain rehabilitation intervention
Attention ControlBEHAVIORAL

Usual care with bi-weekly contact from study staff

Attention Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Thomas Jefferson University and Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (12)

  • Damluji AA, Bruce SA, Reeves G, Pastva AM, Bertoni AG, Mentz RJ, Whellan DJ, Kitzman DW, deFilippi CR. Circulating Biomarkers as Predictors of Improvement in Physical Function in Hospitalized Older Adults With Geriatric Syndromes: Findings From the REHAB-HF Trial. Circ Heart Fail. 2026 Jan 7:e013251. doi: 10.1161/CIRCHEARTFAILURE.125.013251. Online ahead of print.

    PMID: 41500239DERIVED

  • Corsi DR, Dikdan S, Upadhyay N, Chen H, Kitzman DW, Mentz R, Whellan DJ, Frisch DR. Atrial Fibrillation Status and Physical Rehabilitation in Older Patients With Acute Decompensated Heart Failure: An Analysis From the REHAB-HF Trial. J Am Heart Assoc. 2024 Oct;13(19):e034366. doi: 10.1161/JAHA.124.034366. Epub 2024 Sep 18.

    PMID: 39291487DERIVED

  • Gilbert ON, Mentz RJ, Bertoni AG, Kitzman DW, Whellan DJ, Reeves GR, Duncan PW, Nelson MB, Blumer V, Chen H, Reed SD, Upadhya B, O'Connor CM, Pastva AM. Relationship of Race With Functional and Clinical Outcomes With the REHAB-HF Multidomain Physical Rehabilitation Intervention for Older Patients With Acute Heart Failure. J Am Heart Assoc. 2023 Nov 7;12(21):e030588. doi: 10.1161/JAHA.123.030588. Epub 2023 Oct 27.

    PMID: 37889196DERIVED

  • Pandey A, Kitzman DW, Nelson MB, Pastva AM, Duncan P, Whellan DJ, Mentz RJ, Chen H, Upadhya B, Reeves GR. Frailty and Effects of a Multidomain Physical Rehabilitation Intervention Among Older Patients Hospitalized for Acute Heart Failure: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2023 Feb 1;8(2):167-176. doi: 10.1001/jamacardio.2022.4903.

    PMID: 36598761DERIVED

  • 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.

    PMID: 36372251DERIVED

  • 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.

    PMID: 36345825DERIVED

  • 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.

    PMID: 36164731DERIVED

  • 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.

    PMID: 35656973DERIVED

  • 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.

    PMID: 34246602DERIVED

  • 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.

    PMID: 33999544DERIVED

  • 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.

    PMID: 30571197DERIVED

  • 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.

    PMID: 28285121DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Dalane Kitzman
Organization
Wake Forest School of Medicine
dkitzman@wakehealth.edu
336-716-3274

Study Officials

  • Dalane W. Kitzman, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 21, 2014

Study Start

September 1, 2014

Primary Completion

June 15, 2020

Study Completion

July 27, 2020

Last Updated

June 24, 2021

Results First Posted

June 23, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(3)