Critical IllnessICU-RehabNCT07179718
Intensive Care Unit Rehabilitation Protocols
A study testing neuromuscular electrical stimulation and bicycle ergometer in people with Critical Illness and ICU Patients, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, ICU Patients
- What is being tested?
- neuromuscular electrical stimulation and bicycle ergometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jun 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Admitted to medical intensive care unit
- Expected intensive care unit stay > 48 hours
- Hemodynamically stable
Who cannot join
- Severe neurological injury (e.g., acute stroke, spinal cord injury)
- Terminal illness with palliative care decision
- Severe orthopedic limitations preventing mobilization
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Medical Intensive Care Unit
Ankara, ALTINDAG, 06230
About this study
Official title: Effects of Two Different Rehabilitation Protocols on Mobility, Functional Status, Muscle Parameters, and Hemodynamic Responses in Intensive Care Patients
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
- Being tested
- neuromuscular electrical stimulation, bicycle ergometer
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular electrical stimulationDevice
Neuromuscular electrical stimulation (NMES) is a treatment method in which electrical conduction via surface electrodes is used to stimulate muscle contraction.
bicycle ergometerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: neuromuscular electrical stimulation; Device: bicycle ergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1st and 5th day of 5-day physiotherapy and rehabilitation after the patient is clinically stable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start21 Jun 2024
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SELMAN KILIÇ, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179718
- Sponsor's protocol ID
- KA-22100
- Acronym
- ICU-Rehab
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Different Rehabilitation Protocols on Mobility, Functional Status, Muscle Parameters, and Hemodynamic Responses in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT07179718
- Acronym / sponsor ID
- ICU-Rehab / KA-22100
- Conditions
- Critical Illness, ICU Patients
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bicycle ergometer group | Experimental | Device: bicycle ergometerExercise 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 | Experimental | Device: neuromuscular electrical stimulation, Device: bicycle ergometerGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Admitted to medical intensive care unit
- Expected intensive care unit stay > 48 hours
- Hemodynamically stable
Key exclusion criteria (4 listed)
- Severe neurological injury (e.g., acute stroke, spinal cord injury)
- Terminal illness with palliative care decision
- Severe orthopedic limitations preventing mobilization
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuromuscular electrical stimulationNeuromuscular electrical stimulation (NMES) is a treatment method in which electrical conduction via surface electrodes is used to stimulate muscle contraction. | Device | bicycle ergometer + neuromuscular electrical stimulation group |
| bicycle ergometerExercise 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 + neuromuscular electrical stimulation group, bicycle ergometer group |
Primary outcome
Change in Perme Intensive Care Unit Mobility Score over 5 days
Time frame: 1st and 5th day of 5-day physiotherapy and rehabilitation after the patient is clinically stable
The total score ranges from 0 to 32 points, with higher scores indicating better mobility and greater independence.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuromuscular electrical stimulation and bicycle ergometer in people with Critical Illness and ICU Patients, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perme Intensive Care Unit Mobility Score over 5 days (time frame: 1st and 5th day of 5-day physiotherapy and rehabilitation after the patient is clinically stable). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.