Intensive Care Unit Rehabilitation Protocols

NCT ID: NCT07179718

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-21
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bicycle ergometer group

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.

Group Type: EXPERIMENTAL

bicycle ergometer

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

neuromuscular electrical stimulation

Intervention Type: DEVICE

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

bicycle ergometer

Intervention Type: 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.

Interventions

neuromuscular electrical stimulation

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

Intervention Type: DEVICE

bicycle ergometer

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

SELMAN KILIÇ

Mr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hacettepe University Medical Intensive Care Unit

Ankara, ALTINDAG, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KA-22100

Identifier Type: -

Identifier Source: org_study_id