Remote Multicomponent Rehabilitation in Intensive Care Unit Survivors: A Randomized Clinical Trial

Clinical Snapshot

Key Findings

• P Value: P = .05 for primary outcome (borderline; does not reach conventional α = 0.05 threshold for statistical significance under a two-sided test)

• Effect Size: Adjusted mean difference in EQ-5D-5L utility score: +0.04 (below the MCID of 0.08). Four of six secondary outcomes improved: leg strength, exercise capacity, fatigue, and anxiety. No significant change in depression perception or illness perception.

• Primary Outcome: EQ-5D-5L utility score at 8 weeks: 0.69 (SD 0.26) in the intervention group vs 0.67 (SD 0.27) in the standard care group. The adjusted mean difference of 0.04 did not meet the pre-specified MCID of 0.08. The trial did not demonstrate a clinically important improvement in HRQoL.

• Nnt Or Sensitivity: NNT cannot be calculated from continuous EQ-5D-5L utility score data as reported. The effect size of 0.04 utility points represents approximately 50% of the MCID (0.08), indicating a clinically subthreshold benefit. No NNT for dichotomised outcomes was reported in the abstract.

• Confidence Interval: 95% CI for primary outcome adjusted mean difference: -0.001 to 0.09. The upper bound marginally exceeds the MCID, meaning a small clinically important benefit cannot be entirely excluded but is not supported by the point estimate.

Abstract

IMPORTANCE: Evidence for remote multicomponent rehabilitation among critical care survivors is sparse. OBJECTIVE: To investigate the effects of a 6-week, remote, multicomponent rehabilitation intervention in survivors of critical illness following discharge from the hospital after an intensive care unit (ICU) admission compared with standard care on health-related quality of life at 8 weeks. DESIGN, SETTING, AND PARTICIPANTS: Pragmatic, multicenter, assessor-blinded, randomized clinical trial conducted from December 2022 to November 2025 at 52 National Health Service hospitals in the UK. Participants were adults who had been discharged from the hospital within the last 12 weeks with an ICU admission (required mechanical ventilation for ≥48 hours during ICU stay). INTERVENTIONS: Individuals were randomized to a 6-week, remote, multicomponent, individualized, rehabilitation intervention incorporating weekly symptom management; targeted exercise; psychological support; and peer support and information commenced within 12 weeks of hospital discharge (n = 231) or standard care (n = 198). MAIN OUTCOMES AND MEASURES: The primary outcome was health-related quality of life at 8 weeks measured by the EuroQoL 5-dimension 5-level questionnaire (EQ-5D-5L) utility score (from -0.285 [worst/worse than dead] to 1 [best health]; minimum clinically important difference: 0.08) and analyzed using linear regression (adjusted for baseline covariates). The secondary outcomes included leg strength and exercise capacity; self-reported perception of fatigue, anxiety, or depression; illness perception; acceptability of the intervention; and any adverse events. RESULTS: Of the 3705 screened patients, 429 (12%) were randomized (mean age, 55.4 [SD, 13.9] years; 184 female [42.9%]; 245 male [57.1%]; and had median Acute Physiology and Chronic Health Evaluation II score of 18 [IQR, 14 to 22]). The mean EQ-5D-5L utility score at 8 weeks was 0.69 (SD, 0.26) in the intervention group compared with 0.67 (SD, 0.27) in the standard care group (adjusted mean difference, 0.04 [95% CI, -0.001 to 0.09]; P = .05). The intervention improved 4 of the 6 secondary outcomes, including leg strength and exercise capacity, fatigue, anxiety, and acceptability of the intervention; there was no change in perception of depression or illness. Four adverse events were related to the intervention; no serious events were attributed to the intervention. CONCLUSIONS AND RELEVANCE: A 6-week, multicomponent, rehabilitation program did not improve health-related quality of life at 8 weeks after discharge in ICU survivors who required mechanical ventilation. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN11266403.