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Acute Decompensated Heart FailureREHAB-HFNCT02196038

A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients

A study testing multi-domain rehabilitation intervention in people with Acute Decompensated Heart Failure, run by Wake Forest University Health Sciences at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Acute Decompensated Heart Failure
What is being tested?
multi-domain rehabilitation intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
349 participants
Where
3 sitesUnited States
Study dates
Sep 2014to 27 Jul 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Thomas Jefferson University and Hospital

    Philadelphia, Pennsylvania, 19107

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
multi-domain rehabilitation intervention, Attention Control
Keywords
heart failure
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • multi-domain rehabilitation interventionBehavioural

    Individual, tailored, progressive physical function rehabilitation intervention

  • Attention ControlBehavioural

    Usual care with bi-weekly contact from study staff

Study groups in NCT02196038
Study groupRoleWhat they receive
Attention ControlOtherUsual care group with bi-weekly contact from study staff
Receives: Behavioral: Attention Control
multi-domain rehabilitation interventionActive comparatorIndividual, tailored, progressive, physical function rehabilitation intervention
Receives: Behavioral: multi-domain rehabilitation intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Month 3

Secondary outcomes (1)

  1. All-Cause Rehospitalization

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

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2014 (estimated)
  2. Study startSep 2014
  3. Primary completion15 Jun 2020
  4. Study completion27 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02196038
Sponsor's protocol ID
IRB00028221
Other IDs
R01AG045551
Acronym
REHAB-HF
Status last verified
Sep 2020
First submitted
15 Jul 2014
Last updated
24 Jun 2021
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Semelka CT, Ehrig MR, Pajewski NM, Kritchevsky SB, Kramer PA, Peters AE, Mentz RJ, Pastva AM, Whellan DJ, Kitzman DW. Senescence Biomarkers Predict Physical Function and Clinical Outcomes After Heart Failure Hospitalization: Insights From REHAB-HF. J Gerontol A Biol Sci Med Sci. 2026 Oct 30:glag256. doi: 10.1093/gerona/glag256. Online ahead of print.

    PubMed 42968386

  • 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.

    PubMed 41500239

  • 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.

    PubMed 39291487

  • 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.

    PubMed 37889196

  • 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.

    PubMed 36598761

  • 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.

    PubMed 36372251

  • 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.

    PubMed 36345825

  • 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.

    PubMed 36164731

  • 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.

    PubMed 35656973

  • 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.

    PubMed 34246602

  • 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.

    PubMed 33999544

  • 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.

    PubMed 30571197

  • 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.

    PubMed 28285121

Questions about this trial

What is this clinical trial studying?

A study testing multi-domain rehabilitation intervention in people with Acute Decompensated Heart Failure, run by Wake Forest University Health Sciences at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short Physical Performance Battery (SPPB) at Month 3 (time frame: Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02196038, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.

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