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

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

Study Overview

• Status: Recruiting
• Conditions: Intensive Care Unit Acquired Weakness
• Intervention / Treatment: Behavioral: Threshold IMT and traditional physical therapy program; Behavioral: traditional physiotherapy program

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ali MA Ismail, lecturer; Phone Number: 01005154209; Email: ali.mohamed@pt.cu.edu.eg
• Study Contact Backup: Name: hany elsisi, professor; Email: elsisihany309@gmail.com

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Cairo Unoversity
    • Contact: Ali Ismail, lecturer; Phone Number: 01005154209; Email: allooka2012@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Functional Ambulation Category Test	it is a category test used to assess walking disability	it will be measured after 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional vital capacity	the percentage of predicted value of functional vital capacity will be assessed	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	It will be measured after 1 month
Partial Pressure of Oxygen	it is an arterial blood gas test	It will be measured after 1 month
Partial Pressure of carbon dioxide	it is an arterial blood gas test	It will be measured after 1 month
Oxygen saturation	it is an arterial blood gas test	It will be measured after 1 month
inspiratory muscle strength	it will be measure in cm H2O	It will be measured after 1 month
expiratory muscle strength	it will be measure in cm H2O	It will be measured after 1 month
time up and go test	it is time used to walk a three-meter distance	It will be measured after 1 month
30-second sit to stand	number of (sit to stand) done in 30 seconds	It will be measured after 1 month
six-minute walk test,	distance walked in 6 minute	It will be measured after 1 month
10-meter walking test	it is time used to walk a 10-meter distance	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	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	It will be measured after 1 month

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Ali MA Ismail, lecturer, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2023
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Estimated): January 18, 2024

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Asthenia
• Other Study ID Numbers: P.T.REC/012/004624

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No