Clinical trial NCT06210763: IMT Outcomes in Sufferers of Severe Walking Disabilities and Intensive Care Unit Acquired Weakness
Official title: Inspiratory Muscle Training Outcomes in Sufferers of Severe Walking Disabilities and Intensive Care Unit Acquired Weakness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intensive Care Unit Acquired Weakness
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Functional Ambulation Category Test
timeFrame: it will be measured after 1 month
Secondary outcomes:
measure: functional vital capacity
timeFrame: It will be measured after 1 month
measure: forced expiatory volume in the first second of expiration
timeFrame: It will be measured after 1 month
measure: Partial Pressure of Oxygen
timeFrame: It will be measured after 1 month
measure: Partial Pressure of carbon dioxide
timeFrame: It will be measured after 1 month
measure: Oxygen saturation
timeFrame: It will be measured after 1 month
measure: inspiratory muscle strength
timeFrame: It will be measured after 1 month
measure: expiratory muscle strength
timeFrame: It will be measured after 1 month
measure: time up and go test
timeFrame: It will be measured after 1 month
measure: 30-second sit to stand
timeFrame: It will be measured after 1 month
measure: six-minute walk test,
timeFrame: It will be measured after 1 month
measure: 10-meter walking test
timeFrame: It will be measured after 1 month
measure: mental division of short form 36
timeFrame: It will be measured after 1 month
measure: physical division of short form 36
timeFrame: It will be measured after 1 month
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo Unoversity
Study officials:
affiliation: Cairo University
name: Ali MA Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References: