A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients
NCT ID: NCT02196038
Last Updated: 2021-06-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
349 participants
INTERVENTIONAL
2014-09-30
2020-07-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Attention Control
Usual care group with bi-weekly contact from study staff
Attention Control
Usual care with bi-weekly contact from study staff
multi-domain rehabilitation intervention
Individual, tailored, progressive, physical function rehabilitation intervention
multi-domain rehabilitation intervention
Individual, tailored, progressive physical function rehabilitation intervention
Interventions
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multi-domain rehabilitation intervention
Individual, tailored, progressive physical function rehabilitation intervention
Attention Control
Usual care with bi-weekly contact from study staff
Eligibility Criteria
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Inclusion Criteria
* 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
* Planned discharge other than to home or a facility where the participant will live independently
* Already actively participating in formal, facility-based cardiac rehabilitation
60 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Dalane W. Kitzman, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Thomas Jefferson University and Hospital
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB00028221
Identifier Type: -
Identifier Source: org_study_id
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