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

Intensive Care Unit Acquired Weakness Clinical Trial

Official title:

Inspiratory Muscle Training Outcomes in Sufferers of Severe Walking Disabilities and Intensive Care Unit Acquired Weakness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06210763
• Other study ID #: P.T.REC/012/004624
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: Ali MA Ismail, lecturer
• Phone: 01005154209
• Email: ali.mohamed[@]pt.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthenia
• Intensive Care Unit Acquired Weakness

Intervention

Behavioral:
• 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.
• 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).

Locations

Country	Name	City	State
Egypt	Cairo Unoversity	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Functional Ambulation Category Test	it is a category test used to assess walking disability	it will be measured after 1 month
Secondary	functional vital capacity	the percentage of predicted value of functional vital capacity will be assessed	It will be measured after 1 month
Secondary	forced expiatory volume in the first second of expiration	the percentage of predicted value of FEV1 will be assessed	It will be measured after 1 month
Secondary	Partial Pressure of Oxygen	it is an arterial blood gas test	It will be measured after 1 month
Secondary	Partial Pressure of carbon dioxide	it is an arterial blood gas test	It will be measured after 1 month
Secondary	Oxygen saturation	it is an arterial blood gas test	It will be measured after 1 month
Secondary	inspiratory muscle strength	it will be measure in cm H2O	It will be measured after 1 month
Secondary	expiratory muscle strength	it will be measure in cm H2O	It will be measured after 1 month
Secondary	time up and go test	it is time used to walk a three-meter distance	It will be measured after 1 month
Secondary	30-second sit to stand	number of (sit to stand) done in 30 seconds	It will be measured after 1 month
Secondary	six-minute walk test,	distance walked in 6 minute	It will be measured after 1 month
Secondary	10-meter walking test	it is time used to walk a 10-meter distance	It will be measured after 1 month
Secondary	mental division of short form 36	it assess mental component of short form 36 quality of life questionnare	It will be measured after 1 month
Secondary	physical division of short form 36	it assess physical component of short form 36 quality of life questionnare	It will be measured after 1 month