Effects of Cardiopulmonary Rehabilitation in Participants With Post-Intensive Care Syndrome.

Overview

Survivors of prolonged critical illness may develop post-intensive care syndrome, with reduced respiratory and peripheral muscle function and exercise capacity. This trial compared a home-based rehabilitation programme delivered through a self-explanatory workbook with weekly telephone monitoring against centre-based supervised rehabilitation. The secondary objectives will be: To compare the effects of a supervised program of 12 weeks of supervised exercises and a program of self-performed home exercises, guided by an exercise booklet, of the same duration on muscle strength and peripheral resistance; Compare the effects of a 12-week supervised exercise program and a self-performed home exercise program, guided by an exercise booklet, of the same duration on health-related quality of life and functional status.

This is a randomized, controlled, assessor-blind treatment trial with a 1:1 allocation ratio. Participants: Patients will be recruited at the Central Hospital of the Military Police and in the specialized multidisciplinary follow-up outpatient rehabilitation center. The participants will be adults (≥18 years and ≤ 65 years), who required hospitalization and need for invasive mechanical ventilation for at least 7 days and who were discharged after, between three and six months from hospital discharge between 2023 to 2025. Intervention and comparison: This study will be divided into three groups: control group(standard rehabilitation), face-to-face home intervention group. Both groups will be evaluated before and after the study period. Physical functions and functional capacity will be evaluated. After ensuring that patients meet the inclusion criteria, they will be divided into groups that will receive supervised care in a supervised Pulmonary Rehabilitation Center, with protocoled exercises, the other group will receive a booklet of self-explanatory exercises for performing the exercises in home. The intervention groups should perform the exercises in the period of 12 weeks, 3 times a week, totaling 36 intervention sessions. Blinding The allocation sequence was generated before the start of enrolment. The assessor who performed the baseline clinical and functional evaluation was unaware of the arm to which the participant had been allocated, because allocation was disclosed only after that evaluation had been completed and recorded. Participants then followed the allocation already generated. The physiotherapists who delivered the rehabilitation sessions applied the assigned protocol and were not informed of the outcomes under investigation or of the hypothesis of the trial, so that their conduct of the sessions could not be oriented towards any particular outcome; they could not be blinded to the modality itself, since the two programmes are delivered in different settings. The assessor who performed the 12-week evaluation was unaware of the arm to which the participant had been allocated. Participants could not be blinded to the modality they received. State whether the baseline and 12-week assessments were performed by different assessors, what measures prevented participants from revealing their allocation during the 12-week assessment, and whether the statistician was unaware of allocation during the analysis. Data monitoring The trial is overseen by a data monitoring committee constituted at the institution to oversee its randomized clinical trials. The committee comprises five members, none of whom is a member of the study team or takes part in recruitment, delivery of the interventions, outcome assessment or data analysis. One member is the chair of the institutional Research Ethics Committee.