NCT07584564

Brief Summary

Muscle weakness acquired in the ICU (FAUTI) is related to the functional decline of patients admitted to an Intensive Care Unit (ICU). For better follow-up, scales such as (Chelsea Critical Care Physical Assessment) CPAx and (Medical Research Council) MRC help to identify early the muscle and functional impairment of these patients. Early mobilization aims to minimize these effects and therefore the search to reach the highest mobility milestone is constant bedside sitting (BSS) is an important milestone in recovery, associated with better functional results when there is good trunk control, as the coordinated activation of muscles in this region is essential for stabilization and reaching higher postures. The physiotherapeutic approach focused on the components of the activities and on the patient's participation is crucial, with the therapeutic option of Proprioceptive Neuromuscular Facilitation (PNF). To evaluate the effect of exercises based on the PNF concept through the Test Control Trunk (TCT) on the trunk balance of patients admitted to the ICU. This is a randomized, crossover clinical trial, carried out at the Pedro Ernesto University Hospital from June 2026 to June 2027. Adults hospitalized for more than 48 hours who meet the inclusion criteria will be screened. and clinical evaluation. The study consists of two blocks of pre- and post-crossover evaluations, conducted by the same blind evaluator. Patients will undergo assessments on the first day of BSS, including assessment of the trunk with TCT and assessment of diaphragm mobility and thickness by ultrasound, before and after intervention (PNF or conventional exercises). Between assessments, there will be a 3-hour rest period.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

April 29, 2026

Last Update Submit

May 18, 2026

Conditions

Keywords

Postural BalanceProprioceptive Neuromuscular FacilitationDiaphragm

Outcome Measures

Primary Outcomes (1)

  • Trunk Control

    Trunk stability assessment will be performed on the first day of sitting at the bedside, both before and after treatment, for both groups. The Trunk Control Test (TCT) will be used. The TCT is a test used as a predictor of return to walking within 18 weeks, when the patient is able to obtain 50 points or more within 6 weeks. The test examines four simple aspects of trunk movement. The patient begins the test in the supine position, is asked to roll to both sides, then sit up from the lying position, and finally maintain a balanced position on the edge of the bed with their feet off the ground for a minimum of 30 seconds. In each aspect, the patient can receive a score of 0, 12, or 25. The total value is the sum of the four aspects evaluated, totaling 100 points. Regarding balance in the seated position, a score of 12 is considered when the patient needs to lean on something to maintain the position, and 0 when they are unable to maintain the posture (COLLIN; WADE, 1990).

    Day 1

Secondary Outcomes (4)

  • Functional Assesment

    6 months

  • Diaphragmatic thickness

    Day 1

  • Diaphragmatic excursion

    Day 1

  • Length of stay in the ICU

    28-day interval.

Study Arms (2)

standard physiotherapy

ACTIVE COMPARATOR

This group will undergo conventional physiotherapy according to institutional protocol. Rehabilitation will be geared towards achieving daily motor milestones (sitting on the edge of the bed, sitting in a chair, standing up, and walking) according to the CPAx scale. We will record whether patients achieved any milestones during their stay in the ICU and the number of days required to achieve them.

Other: Standard physiotherapy

Proprioceptive Neuromuscular Facilitation (PNF)

EXPERIMENTAL

Patients will undergo a protocol that respects the principles and procedures of PNF, as well as the stages of motor control model, such as: mobility, stability, and mobility over stability. Activities will begin in bed and conclude in the sitting over of the edge. It will begin with exercises in the right and left lateral decubitus positions: solid flexion and solid extension. Next, trunk stability exercises will be performed in a seated position at the edge of the bed.

Other: Proprioceptive Neuromuscular Facilitation (PNF)

Interventions

From its beginnings, PNF has successfully integrated many of the concepts of contemporary neurorehabilitation interventions. The Philosophy and Basic Principles of PNF, together with the specific spiral and diagonal patterns, make up the cornerstone of PNF. PNF also includes motor learning and functional retention of newly learned activities with the repetition of a specific demand; the use of the developmental progression of motor behavior that enables patients to create and re-create strategies of efficient functional movement; and the biomechanical and behavioral analysis of motor control. All activities within PNF intervention are directed towards a functional goal and are relative to the environment in which the goal is to be achieved.

Proprioceptive Neuromuscular Facilitation (PNF)

This group will undergo conventional physiotherapy according to institutional protocol.

standard physiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years of age
  • ICU stay greater than or equal 48 hours;
  • RASS scale score greater than or equal to -2 and less than or equal to 1;
  • TCT score less than or equal to 12 points on the "balance in sitting position" score less than or equal to 2 on item 3 "sitting without support".

You may not qualify if:

  • Patients in a coma, with spinal cord instability, metastases, and bone lesions;
  • Neuromuscular or neurological diseases
  • Discharge from the general ICU before SBL
  • Proportional care phase 3;
  • Readmissions to the general ICU;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pedro Ernesto University Hospital

Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

Location

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Gabriel Gomes Maia

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Pneumology

Study Record Dates

First Submitted

April 29, 2026

First Posted

May 13, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations