Intensive Care Unit Acquired WeaknessNCT06210763
IMT Outcomes in Sufferers of Severe Walking Disabilities and Intensive Care Unit Acquired Weakness
A study testing Threshold IMT and traditional physical therapy program and traditional physiotherapy program in people with Intensive Care Unit Acquired Weakness, run by Cairo University at 1 site in Egypt.
Trial summary
Intensive care unit-acquired weakness (ICU-acquired weakness) may be caused by a variety of different causes. Several studies have shown that ICU-acquired weakness occurs in up to 30% of critically ill patients. It affects daily activities, walking, and functional performance Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Intensive Care Unit Acquired Weakness
- What is being tested?
- Threshold IMT and traditional physical therapy program and traditional physiotherapy program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Aug 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- sufferers with intensive care unit acquired weakness
- Older sufferers patients with severe walking disability detected by Modified Functional Ambulation Category test,
Who cannot join
- lower limb amputations
- orthopedic or spinal disc disorders
Trial locations and contacts
1 site in 1 country.
hany elsisi, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo Unoversity
Giza
Ali Ismail, lecturer, 01005154209, allooka2012@gmail.com
About this study
Official title: Inspiratory Muscle Training Outcomes in Sufferers of Severe Walking Disabilities and Intensive Care Unit Acquired Weakness
Intensive care unit-acquired weakness (ICU-acquired weakness) may be caused by a variety of different causes. Several studies have shown that ICU-acquired weakness occurs in up to 30% of critically ill patients. It affects daily activities, walking, and functional performance
Read the detailed description
Forty ICU-acquired weakness elderly patients will be randomly assigned to group A and group B, 20 elderly for each. Both groups will receive chest physiotherapy (cough training, vibration, percussion, rib springing, and postural drainage), 30 minutes of resisted training on upper- and lower-limb muscles (15 min on upper limb and 15 min on lower limb), and 30 minutes of neuromuscular electrical stimulation of lower- and upper-limb muscles (triceps and wrist extensors, dorsiflexors, and quadriceps). sessions will be executed 5 times weekly). Group A only will receive 3-set IMT (two sessions daily via threshold IMT, the set contain 10 repetitions) 5 times weekly. The study duration will be 1 month.
- Conditions
- Intensive Care Unit Acquired Weakness
- Being tested
- Threshold IMT and traditional physical therapy program, traditional physiotherapy program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold IMT and traditional physical therapy programBehavioural
twenty ICU-acquired weakness elderly patients will receive chest physiotherapy (cough training, vibration, percussion, rib springing, and postural drainage), 30 minutes of resisted training on upper- and lower-limb muscles (15 min on upper limb and 15 min on lower limb), and 30 minutes of neuromuscular electrical stimulation of lower- and upper-limb muscles (triceps and wrist extensors, dorsiflexors, and quadriceps). sessions will be executed 5 times weekly). this Group will receive 3-set IMT (two sessions daily via threshold IMT, the set contain 10 repetitions) 5 times weekly. The study duration will be 1 month.
traditional physiotherapy programBehavioural
twenty ICU-acquired weakness elderly patients will receive chest physiotherapy (cough training, vibration, percussion, rib springing, and postural drainage), 30 minutes of resisted training on upper- and lower-limb muscles (15 min on upper limb and 15 min on lower limb), and 30 minutes of neuromuscular electrical stimulation of lower- and upper-limb muscles (triceps and wrist extensors, dorsiflexors, and quadriceps). sessions will be executed 5 times weekly).
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | twenty ICU-acquired weakness elderly patients will receive chest physiotherapy (cough training, vibration, percussion, rib springing, and postural drainage), 30 minutes of resisted training on upper- and lower-limb muscles (15 min on upper limb and 15 min on lower limb), and 30 minutes of neuromuscular electrical stimulation of lower- and upper-limb muscles (triceps and wrist extensors, dorsiflexors, and quadriceps). sessions will be executed 5 times weekly). this Group will receive 3-set IMT (two sessions daily via threshold IMT, the set contain 10 repetitions) 5 times weekly. The study duration will be 1 month. Receives: Behavioral: Threshold IMT and traditional physical therapy program |
| group B | Active comparator | twenty ICU-acquired weakness elderly patients will receive chest physiotherapy (cough training, vibration, percussion, rib springing, and postural drainage), 30 minutes of resisted training on upper- and lower-limb muscles (15 min on upper limb and 15 min on lower limb), and 30 minutes of neuromuscular electrical stimulation of lower- and upper-limb muscles (triceps and wrist extensors, dorsiflexors, and quadriceps). sessions will be executed 5 times weekly). The study duration will be 1 month. Receives: Behavioral: traditional physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Functional Ambulation Category Test
it is a category test used to assess walking disability
Measured: it will be measured after 1 month
Secondary outcomes (13)
functional vital capacity
the percentage of predicted value of functional vital capacity will be assessed
Measured: It will be measured after 1 month
forced expiatory volume in the first second of expiration
the percentage of predicted value of FEV1 will be assessed
Measured: It will be measured after 1 month
Partial Pressure of Oxygen
it is an arterial blood gas test
Measured: It will be measured after 1 month
Partial Pressure of carbon dioxide
it is an arterial blood gas test
Measured: It will be measured after 1 month
Oxygen saturation
it is an arterial blood gas test
Measured: It will be measured after 1 month
inspiratory muscle strength
it will be measure in cm H2O
Measured: It will be measured after 1 month
expiratory muscle strength
it will be measure in cm H2O
Measured: It will be measured after 1 month
time up and go test
it is time used to walk a three-meter distance
Measured: It will be measured after 1 month
30-second sit to stand
number of (sit to stand) done in 30 seconds
Measured: It will be measured after 1 month
six-minute walk test,
distance walked in 6 minute
Measured: It will be measured after 1 month
10-meter walking test
it is time used to walk a 10-meter distance
Measured: It will be measured after 1 month
mental division of short form 36
it assess mental component of short form 36 quality of life questionnare
Measured: It will be measured after 1 month
physical division of short form 36
it assess physical component of short form 36 quality of life questionnare
Measured: It will be measured after 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start2 Aug 2023
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit Acquired WeaknessStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali MA Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210763
- Sponsor's protocol ID
- P.T.REC/012/004624
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alahmari M, Elsisi HF, Ismail AMA. Functional outcomes of inspiratory muscle training in elderly with intensive care unit-acquired weakness and severe walking disability. Ir J Med Sci. 2025 Apr;194(2):761-769. doi: 10.1007/s11845-025-03876-w. Epub 2025 Feb 3.
PubMed 39899253
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training Outcomes in Sufferers of Severe Walking Disabilities and Intensive Care Unit Acquired Weakness
- ClinicalTrials.gov ID
- NCT06210763
- Acronym / sponsor ID
- P.T.REC/012/004624
- Conditions
- Intensive Care Unit Acquired Weakness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 18 Jan 2024 (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.
Intensive care unit-acquired weakness (ICU-acquired weakness) may be caused by a variety of different causes. Several studies have shown that ICU-acquired weakness occurs in up to 30% of critically ill patients. It affects daily activities, walking, and functional performance
Detailed description
Forty ICU-acquired weakness elderly patients will be randomly assigned to group A and group B, 20 elderly for each. Both groups will receive chest physiotherapy (cough training, vibration, percussion, rib springing, and postural drainage), 30 minutes of resisted training on upper- and lower-limb muscles (15 min on upper limb and 15 min on lower limb), and 30 minutes of neuromuscular electrical stimulation of lower- and upper-limb muscles (triceps and wrist extensors, dorsiflexors, and quadriceps). sessions will be executed 5 times weekly). Group A only will receive 3-set IMT (two sessions daily via threshold IMT, the set contain 10 repetitions) 5 times weekly. The study duration will be 1 month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Behavioral: Threshold IMT and traditional physical therapy programtwenty ICU-acquired weakness elderly patients will receive chest physiotherapy (cough training, vibration, percussion, rib springing, and postural drainage), 30 minutes of resisted training on upper- and lower-limb muscles (15 min on upper limb and 15 min on lower limb), and 30 minutes of neuromuscular electrical stimulation of lower- and upper-limb muscles (triceps and wrist extensors, dorsiflexors, and quadriceps). sessions will be executed 5 times weekly). this Group will receive 3-set IMT (two sessions daily via threshold IMT, the set contain 10 repetitions) 5 times weekly. The study duration will be 1 month. |
| group B | Active comparator | Behavioral: traditional physiotherapy programtwenty ICU-acquired weakness elderly patients will receive chest physiotherapy (cough training, vibration, percussion, rib springing, and postural drainage), 30 minutes of resisted training on upper- and lower-limb muscles (15 min on upper limb and 15 min on lower limb), and 30 minutes of neuromuscular electrical stimulation of lower- and upper-limb muscles (triceps and wrist extensors, dorsiflexors, and quadriceps). sessions will be executed 5 times weekly). The study duration will be 1 month. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- sufferers with intensive care unit acquired weakness
- Older sufferers patients with severe walking disability detected by Modified Functional Ambulation Category test,
Key exclusion criteria (2 listed)
- lower limb amputations
- orthopedic or spinal disc disorders
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 |
|---|---|---|
| Threshold IMT and traditional physical therapy programtwenty ICU-acquired weakness elderly patients will receive chest physiotherapy (cough training, vibration, percussion, rib springing, and postural drainage), 30 minutes of resisted training on upper- and lower-limb muscles (15 min on upper limb and 15 min on lower limb), and 30 minutes of neuromuscular electrical stimulation of lower- and upper-limb muscles (triceps and wrist extensors, dorsiflexors, and quadriceps). sessions will be executed 5 times weekly). this Group will receive 3-set IMT (two sessions daily via threshold IMT, the set contain 10 repetitions) 5 times weekly. The study duration will be 1 month. | Behavioural | group A |
| traditional physiotherapy programtwenty ICU-acquired weakness elderly patients will receive chest physiotherapy (cough training, vibration, percussion, rib springing, and postural drainage), 30 minutes of resisted training on upper- and lower-limb muscles (15 min on upper limb and 15 min on lower limb), and 30 minutes of neuromuscular electrical stimulation of lower- and upper-limb muscles (triceps and wrist extensors, dorsiflexors, and quadriceps). sessions will be executed 5 times weekly). | Behavioural | group B |
Primary outcome
Modified Functional Ambulation Category Test
Time frame: it will be measured after 1 month
it is a category test used to assess walking disability
13 secondary outcomes
functional vital capacity
Time frame: It will be measured after 1 month
forced expiatory volume in the first second of expiration
Time frame: It will be measured after 1 month
Partial Pressure of Oxygen
Time frame: It will be measured after 1 month
Partial Pressure of carbon dioxide
Time frame: It will be measured after 1 month
Oxygen saturation
Time frame: It will be measured after 1 month
inspiratory muscle strength
Time frame: It will be measured after 1 month
expiratory muscle strength
Time frame: It will be measured after 1 month
time up and go test
Time frame: It will be measured after 1 month
30-second sit to stand
Time frame: It will be measured after 1 month
six-minute walk test,
Time frame: It will be measured after 1 month
10-meter walking test
Time frame: It will be measured after 1 month
mental division of short form 36
Time frame: It will be measured after 1 month
physical division of short form 36
Time frame: It will be measured after 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Derived from this study: PubMed 39899253Alahmari M, Elsisi HF, Ismail AMA. Functional outcomes of inspiratory muscle training in elderly with intensive care unit-acquired weakness and severe walking disability. Ir J Med Sci. 2025 Apr;194(2):761-769. doi: 10.1007/s11845-025-03876-w. Epub 2025 Feb 3.
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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.
hany elsisi, professor contact
Ali MA Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threshold IMT and traditional physical therapy program and traditional physiotherapy program in people with Intensive Care Unit Acquired Weakness, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali MA Ismail, lecturer (01005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Functional Ambulation Category Test (time frame: it will be measured after 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06210763, which also lists 1 linked publication.
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 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.