Effect of Exercise Intervention on Functional Decline in Very Elderly Patients During Acute Hospitalization: A Randomized Clinical Trial

Abstract

Importance: Functional decline is prevalent among acutely hospitalized older patients. Exercise and early rehabilitation protocols applied during acute hospitalization can prevent functional and cognitive decline in older patients.

Objective: To assess the effects of an innovative multicomponent exercise intervention on the functional status of this patient population.

Design, setting, and participants: A single-center, single-blind randomized clinical trial was conducted from February 1, 2015, to August 30, 2017, in an acute care unit in a tertiary public hospital in Navarra, Spain. A total of 370 very elderly patients undergoing acute-care hospitalization were randomly assigned to an exercise or control (usual-care) intervention. Intention-to-treat analysis was conducted.

Interventions: The control group received usual-care hospital care, which included physical rehabilitation when needed. The in-hospital intervention included individualized moderate-intensity resistance, balance, and walking exercises (2 daily sessions).

Main outcomes and measures: The primary end point was change in functional capacity from baseline to hospital discharge, assessed with the Barthel Index of independence and the Short Physical Performance Battery (SPPB). Secondary end points were changes in cognitive and mood status, quality of life, handgrip strength, incident delirium, length of stay, falls, transfer after discharge, and readmission rate and mortality at 3 months after discharge.

Results: Of the 370 patients included in the analyses, 209 were women (56.5%); mean (SD) age was 87.3 (4.9) years. The median length of hospital stay was 8 days in both groups (interquartile range, 4 and 4 days, respectively). Median duration of the intervention was 5 days (interquartile range, 0); there was a mean (SD) of 5 (1) morning and 4 (1) evening sessions per patient. No adverse effects were observed with the intervention. The exercise intervention program provided significant benefits over usual care. At discharge, the exercise group showed a mean increase of 2.2 points (95% CI, 1.7-2.6 points) on the SPPB scale and 6.9 points (95% CI, 4.4-9.5 points) on the Barthel Index over the usual-care group. Hospitalization led to an impairment in functional capacity (mean change from baseline to discharge in the Barthel Index of -5.0 points (95% CI, -6.8 to -3.2 points) in the usual-care group, whereas the exercise intervention reversed this trend (1.9 points; 95% CI, 0.2-3.7 points). The intervention also improved the SPPB score (2.4 points; 95% CI, 2.1-2.7 points) vs 0.2 points; 95% CI, -0.1 to 0.5 points in controls). Significant intervention benefits were also found at the cognitive level of 1.8 points (95% CI, 1.3-2.3 points) over the usual-care group.

Conclusions and relevance: The exercise intervention proved to be safe and effective to reverse the functional decline associated with acute hospitalization in very elderly patients.

Trial registration: ClinicalTrials.gov identifier: NCT02300896.

Figure 1.. Study Flow Diagram

Progress through the phases of the parallel randomized trial of the groups.

Figure 2.. Discrete Changes From Baseline to Discharge According to Treatment Group and Within-Group Score Change Distribution for Both Groups

Changes from baseline to discharge (A and B) and within-group punctuation change distribution (C and D). A, Barthel Index changes: much better indicates an improvement of more than 10 points, better indicates an improvement of 10 or less points, unchanged indicates no difference, worse indicates a decline of 10 or less points, and much worse indicates a decline of more than 10 points. B, Short Physical Performance Battery (SPPB) scale: much better indicates an improvement of 3 or more points, better indicates an improvement of 2 points, slightly better indicates an improvement of 1 point, unchanged indicates no difference, and worse indicates a decline. Differences between the treatment groups were tested with the χ² test for linear trend and revealed a significant intervention effect (P < .01) for both the SPPB scale and Barthel Index. The proportion of patients showing overall improvement and worsening in the Barthel Index or SPBB scale was significantly higher and lower, respectively, in the intervention than in the control group (P value <.001 with χ² test). In the box plots, the box indicates Q1 to Q3; horizontal line within the box, median; error bars, 1.5 × interquartile range; and solid circles beyond the error bars, outliers.