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

Integrated actions to prevent post-intensive care syndrome and better use of health resources.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-108bctm7
Enrollment
Unknown
Registered
2022-07-21
Start date
2022-08-22
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post intensive care syndrome. Rehabilitation

Interventions

Study Protocol The subjects will be randomly allocated into two groups and the sample will consist of 98 subjects (control group n 49 and intervention group n 49) of both sexes, who will meet the incl
- Functionality, through the MIF scale
- Functional Capacity, by the Sit and Stand test
- Degree of muscle strength, by handgrip dynamometry
- Degree of muscle strength for group stratification, by MRC
- Quality of life prior to ICU admission, by EQ-5D. * Intervention: The control group will receive the usual physiotherapeutic treatment in the ward by the HC-UFMG team. Before the beginning of data
E02.760.169.063.500

Sponsors

Hospital das Clínicas da Universidade Federal de Minas Gerais
Lead Sponsor
Hospital das Clínicas da Universidade Federal de Minas Gerais
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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. ;Functional capacity, by the Sit and Stand test, pre and post-intervention and in the 1st, 3rd, 6th and 12th month after hospital discharge. ;Peripheral muscle strength, measured by handgrip dynamometry and pre- and post-intervention MRC. ;Quality of life in the 1st, 3rd, 6th and 12th month after hospital discharge, using the EQ-5D questionnaire.

Countries

Brazil

Contacts

Public ContactGuilherme Rodrigues

Hospital das Clínicas - UFMG

ft_guilhermerodrigues@hotmail.com+55(031)999497373

Outcome results

None listed

Source: REBEC (via WHO ICTRP)