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Randomized Controlled Trial
. 2021 Jul 15;385(3):203-216.
doi: 10.1056/NEJMoa2026141. Epub 2021 May 16.

Physical Rehabilitation for Older Patients Hospitalized for Heart Failure

Affiliations
Randomized Controlled Trial

Physical Rehabilitation for Older Patients Hospitalized for Heart Failure

Dalane W Kitzman et al. N Engl J Med. .

Abstract

Background: 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.

Methods: 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.

Results: 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 (±SE) score on the Short Physical Performance Battery at 3 months was 8.3±0.2 in the intervention group and 6.9±0.2 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).

Conclusions: 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.).

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Figures

Figure 1.
Figure 1.
CONSORT Diagram for the Primary Outcome (SPPB at 3-month Follow-up).
Figure 2.
Figure 2.
Progression of physical function across intervention sessions by exercise domain. As previously described (Reeves, American Heart Journal, 2017; Pastva, Contemporary Clinical Trials, 2018), each exercise session was comprised of 4 domains (balance, strength, mobility, endurance) and four stratification levels (Level 1: red, Level 2: yellow; Level 3: blue; Level 4: green) corresponding to increasing thresholds of functional ability. For all domains, as number of sessions increased throughout the duration of the rehabilitation intervention, proportion of participants at higher levels (3 and 4) generally increased, while lower levels (1 and 2) generally decreased.
Figure 3.
Figure 3.
Forest plot of the effect sizes (units and 95% Confidence Intervals) of the intervention of the pre-specified subgroups for the primary outcome, total SPPB Score. The effect size was relatively large and uniform across a broad range of key subgroups. Abbreviations: RI: Rehabilitation Intervention; AC: Attention Control.

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References

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