Intra-hospital rehabilitation versus conventional physical therapy in post-intensive care syndrome: a randomized controlled trial

Not Applicable

• Conditions: Post intensive care syndrome. Rehabilitation; C10.668.829.800

• Registration Number: RBR-108bctm7
• Lead Sponsor: Hospital das Clínicas da Universidade Federal de Minas Gerais

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-21
• Last Update Posted: 29 May 2023
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

The following will be eligible for the study: patients over 18 years of age who were discharged from the ICU and who has remained in the ICU for at least 5 days and/or who underwent mechanical ventilation for 72 hours or more; patients diagnosed with ICU-acquired muscle weakness with a Medical Research Council (MRC) score of less than 48/60 in 12 muscle groups or an average MRC of minus 4 per muscle group; be able to understand the proposed protocol; have access to a telephone. Will be included in the study: all patients considered eligible and who sign the free and informed consent form. Consent may be provided and the consent form signed by a family member or caregiver, by mutual agreement, in the impossibility of signature by the participant himself.

Exclusion Criteria

Will not be eligible: patients with a survival expectancy of less than six months or who are in palliative care; patients with neurological injury that determines permanent impairment of consciousness, neurodegenerative diseases such as Parkinson's, Alzheimer's or previous dementia or that the reason for admission to the ICU is spinal cord injury (SCI), cerebrovascular accident (CVA) and/or neuromuscular disease, such as Guillian -Barré, Myastenya gravis, multiple and/or amyotrophic lateral sclerosis; present unstable fractures in the upper limbs (MMSS), lower limbs (LL) and spine; presence of absolute or relative contraindications for exercise according to the recommendations of the American College of Sports Medicine. Will be excluded: those who withdraw consent after signing the TCLE; patients who for some reason return to the ICU; participants who are unable to perform the protocol and proposed assessments.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in the frequency of PICS at hospital discharge, measured by PICSq in the 1st, 3rd, 6th and 12th month after hospital discharge.

Secondary Outcome Measures

Name	Time	Method
Mobility, assessed by PERME, pre and post-intervention.;Functionality, assessed by the FIM, pre and post-intervention and in the 1st, 3rd, 6th and 12th month after hospital discharge.<br>;Functional capacity, by the Sit and Stand test, pre and post-intervention and in the 1st, 3rd, 6th and 12th month after hospital discharge.<br>;Peripheral muscle strength, measured by handgrip dynamometry and pre- and post-intervention MRC.<br>;Quality of life in the 1st, 3rd, 6th and 12th month after hospital discharge, using the EQ-5D questionnaire.