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

NCT06210763 | Unknown

• 1 other identifier: P.T.REC/012/004624
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Intensive Care Unit Acquired Weakness

Outcome Measures

Primary Outcomes (1)

• Modified Functional Ambulation Category Test

  it is a category test used to assess walking disability

  it will be measured after 1 month

Secondary Outcomes (13)

• functional vital capacity

  It will be measured after 1 month

• forced expiatory volume in the first second of expiration

  It will be measured after 1 month

• Partial Pressure of Oxygen

  It will be measured after 1 month

• Partial Pressure of carbon dioxide

  It will be measured after 1 month

• Oxygen saturation

  It will be measured after 1 month

Study Arms (2)

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.

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.

Behavioral: traditional physiotherapy program

Interventions

Threshold IMT and traditional physical therapy program 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 A

traditional physiotherapy program 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).

group B

Eligibility Criteria

• Age: 65 Years - 75 Years
• Gender Eligibility Details: self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• lower limb amputations
• orthopedic or spinal disc disorders

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo Unoversity

Giza, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 39899253 DERIVED

Study Officials

• Ali MA Ismail, lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail, lecturer

CONTACT

01005154209; ali.mohamed@pt.cu.edu.eg

hany elsisi, professor

CONTACT

elsisihany309@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: August 2, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

EG (1)