Clinical trial NCT05877989: Evaluation of Effectiveness of Combining High Protein Intake With Early Physical Exercise During Critical Illness
Official title: Evaluation of Effectiveness of Combining High Protein Intake With Early Physical Exercise During Critical Illness to Maintain Muscle Mass in Intensive Care Unite Patient.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Muscle Weakness
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will receive the amino acid intervention that is provided in addition to 'usual care' enteral and/or parenteral nutrition either enteral or parenteral to target a total protein delivery of 2.0g/kg/day. The physical exercise intervention will be delivered by trained nursing staff,and started as close to the time of randomisation as feasible (ie, within 24hours of randomization). The intervention group will receive exercise sessions, for up to 20 min duration.
Primary purpose: TREATMENT

Brief summary: Assessment of Effectiveness of combined high protein intake with early physical exercise by ultrasound measurement of rectus femoris muscle thickness in Intensive Care Unite mechanically ventilated patients.

Detailed description: Muscle wasting and weakness is a frequent finding in critically ill patients and is associated with worse short- and long-term outcomes like delayed liberation from mechanical ventilation, longer Intensive Care Unit and hospital stay, worse physical function and quality of life.

Eligibility criteria: Inclusion Criteria:

* Patients in age group 18-60 years
* Expected Intensive Care Unit stay \>4days after enrolment (to permit adequate exposure to the proposed intervention)
* Previously healthy, Well-nourished, subjects (nutric score=0)

Exclusion Criteria:

* Renal, liver or heart disease or chronic obstructive pulmonary disease
* Previous immune abnormalities (including treatment with corticosteroids)
* Past history of nutritional problems, chronic use of drugs (as drugs inducing myopathies) or orthopedic problems (such as skeletal fractures or immobilization) in the previous 2 years
* Neuromuscular diseases and patients with amputated lower limbs
* Past or recent history of cancer
* Long term critically ill patients shifted from other hospitals
* Pregnant patients

Primary outcomes:
measure: Quantitative changes (cross-section diameter) of rectus femoris muscle
timeFrame: Up to 30 days of Surgical Intensive Care Unit stay.
Secondary outcomes:
measure: Functional capacity.
timeFrame: Up to 30 days of Surgical Intensive Care Unit stay.
measure: Duration of mechanical ventilation.
timeFrame: Up to 30 days of Surgical Intensive Care Unit stay.
measure: Length of Surgical Intensive Care Unit stay.
timeFrame: Up to 30 days
measure: Mortality rate in Surgical Intensive Care Unit
timeFrame: Up to 30 days
measure: Rate of hospital acquired infection.
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
Study officials:
References: