IMT Outcomes in Sufferers of Severe Walking Disabilities and Intensive Care Unit Acquired Weakness

NCT ID: NCT06210763

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-02

Study Completion Date

2024-03-30

Brief Summary

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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

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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

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Intensive Care Unit Acquired Weakness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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group A

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.

Group Type EXPERIMENTAL

Threshold IMT and traditional physical therapy program

Intervention Type BEHAVIORAL

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.

group B

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.

Group Type ACTIVE_COMPARATOR

traditional physiotherapy program

Intervention Type BEHAVIORAL

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).

Interventions

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Threshold IMT and traditional physical therapy program

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.

Intervention Type BEHAVIORAL

traditional physiotherapy program

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* sufferers with intensive care unit acquired weakness
* Older sufferers patients with severe walking disability detected by Modified Functional Ambulation Category test,

Exclusion Criteria

* lower limb amputations
* orthopedic or spinal disc disorders
Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ali Mohamed Ali ismail

lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali MA Ismail, lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Cairo Unoversity

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ali MA Ismail, lecturer

Role: CONTACT

01005154209

hany elsisi, professor

Role: CONTACT

Facility Contacts

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Ali Ismail, lecturer

Role: primary

01005154209

References

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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.

Reference Type DERIVED
PMID: 39899253 (View on PubMed)

Other Identifiers

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P.T.REC/012/004624

Identifier Type: -

Identifier Source: org_study_id

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