Intensive Care Unit Rehabilitation Protocols

NCT07179718 | Active Not Recruiting

• 1 other identifier: KA-22100
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to investigate the effects of NMES combination applied in addition to bicycle ergometry on mobility, functional status, muscle strength and hemodynamic responses in ICU patients. Participants will:

• Exercise training will be performed using the bicycle ergometer method, under the supervision of a physiotherapist, for 30 minutes a day for 5 consecutive days, at the earliest stage when the patient is clinically stable.
• The other group will perform a 30-minute quadriceps muscle NMES session applied with a 4-channel electrical stimulator for 5 consecutive days in addition to the bicycle ergometer.
• Evaluations for both groups will be made on the first day of the study (before starting the exercise training) and at the end of the fifth day (after the exercise training).

Conditions

Critical Illness; ICU Patients

Outcome Measures

Primary Outcomes (1)

• Change in Perme Intensive Care Unit Mobility Score over 5 days

  The total score ranges from 0 to 32 points, with higher scores indicating better mobility and greater independence.

  1st and 5th day of 5-day physiotherapy and rehabilitation after the patient is clinically stable

Study Arms (2)

bicycle ergometer group

EXPERIMENTAL

Exercise training will be performed using the bicycle ergometer method, under the supervision of a physiotherapist, for 30 minutes a day for 5 consecutive days, at the earliest stage when the patient is clinically stable.

Device: bicycle ergometer

bicycle ergometer + neuromuscular electrical stimulation group

EXPERIMENTAL

Group will perform a 30-minute quadriceps muscle NMES session applied with a 4-channel electrical stimulator for 5 consecutive days in addition to the bicycle ergometer.

Device: neuromuscular electrical stimulation; Device: bicycle ergometer

Interventions

neuromuscular electrical stimulation DEVICE

Neuromuscular electrical stimulation (NMES) is a treatment method in which electrical conduction via surface electrodes is used to stimulate muscle contraction.

bicycle ergometer + neuromuscular electrical stimulation group

bicycle ergometer DEVICE

Exercise training will be performed using the bicycle ergometer method, under the supervision of a physiotherapist, for 30 minutes a day for 5 consecutive days, at the earliest stage when the patient is clinically stable.

bicycle ergometer + neuromuscular electrical stimulation group; bicycle ergometer group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Admitted to medical intensive care unit
• Expected intensive care unit stay \> 48 hours
• Hemodynamically stable

You may not qualify if:

• Severe neurological injury (e.g., acute stroke, spinal cord injury)
• Terminal illness with palliative care decision
• Severe orthopedic limitations preventing mobilization
• Pregnancy

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Medical Intensive Care Unit

Ankara, ALTINDAG, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 18, 2025
• Study Start: June 21, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF

Locations

TU (1)