Older patients who are hospitalized for acute decompensated heart failure have high rates of physical frailty, poor quality of life, delayed recovery, and frequent rehospitalizations. Interventions to address physical frailty in this population are not well established.
We conducted a multicenter, randomized, controlled trial to evaluate a transitional, tailored, progressive rehabilitation intervention that included four physical-function domains (strength, balance, mobility, and endurance). The intervention was initiated during, or early after, hospitalization for heart failure and was continued after discharge for 36 outpatient sessions. The primary outcome was the score on the Short Physical Performance Battery (total scores range from 0 to 12, with lower scores indicating more severe physical dysfunction) at 3 months. The secondary outcome was the 6-month rate of rehospitalization for any cause.
A total of 349 patients underwent randomization; 175 were assigned to the rehabilitation intervention and 174 to usual care (control). At baseline, patients in each group had markedly impaired physical function, and 97% were frail or prefrail; the mean number of coexisting conditions was five in each group. Patient retention in the intervention group was 82%, and adherence to the intervention sessions was 67%. After adjustment for baseline Short Physical Performance Battery score and other baseline characteristics, the least-squares mean (¡ÀSE) score on the Short Physical Performance Battery at 3 months was 8.3¡À0.2 in the intervention group and 6.9¡À0.2 in the control group (mean between-group difference, 1.5; 95% confidence interval [CI], 0.9 to 2.0; P<0.001). At 6 months, the rates of rehospitalization for any cause were 1.18 in the intervention group and 1.28 in the control group (rate ratio, 0.93; 95% CI, 0.66 to 1.19). There were 21 deaths (15 from cardiovascular causes) in the intervention group and 16 deaths (8 from cardiovascular causes) in the control group. The rates of death from any cause were 0.13 and 0.10, respectively (rate ratio, 1.17; 95% CI, 0.61 to 2.27).
In a diverse population of older patients who were hospitalized for acute decompensated heart failure, an early, transitional, tailored, progressive rehabilitation intervention that included multiple physical-function domains resulted in greater improvement in physical function than usual care. (Funded by the National Institutes of Health and others; REHAB-HF ClinicalTrials.gov number, NCT02196038.)
Funding and Disclosures
Supported by research grants from the
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
Dr. Kitzman reports receiving steering committee fees and data and safety monitoring board fees from AbbVie, grant support, paid to Wake Forest Baptist Health, and advisory board fees from AstraZeneca and Bayer, advisory board fees from Boehringer Ingelheim and Corvia Medical, consulting fees from Keyto and Merck, and grant support, paid to Wake Forest Baptist Health, and consulting fees from Novartis; Dr. Whellan, receiving grant support, paid to Thomas Jefferson University, from Amgen, end-point committee fees from CVRx and FibroGen, steering committee fees from Cytokinetics, and grant support, paid to Thomas Jefferson University, and advisory board fees from Novo Nordisk; Dr. Duncan, owning stock in Care Directions; and Dr. Mentz, receiving grant support from American Regent and Cytokinetics, consulting fees from Amgen, Boehringer Ingelheim, and Relypsa, research support and honoraria from Abbott, American Regent, Amgen, Boehringer Ingelheim, Eli Lilly, Boston Scientific, Cytokinetics, FAST BioMedical, Gilead Sciences, Innolife, Medtronic, Relypsa, Respicardia, Roche, Sanofi, Vifor Pharma, and Windtree Therapeutics, grant support, research support, and honoraria from AstraZeneca, and research support, consulting fees, and honoraria from Bayer, Merck, and Novartis. No other potential conflict of interest relevant to this article was reported.
This article was published on May 16, 2021, at NEJM.org.
A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.
We thank Alain Bertoni, M.D., Peter Brubaker, Ph.D., and Jack Rejeski, Ph.D. for their critical review and editing of an earlier version of the manuscript; and Timothy Morgan, Ph.D. (deceased), for his biostatistical expertise.
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