Evaluation of Effectiveness of Combining High Protein Intake With Early Physical Exercise During Critical Illness

Muscle Weakness Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05877989
• Other study ID #: 34750/6/21
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Muscle Weakness

Intervention

Drug:
• Amino Acid
Amino acid enteral and/or parenteral nutrition either enteral or parenteral to target a total protein delivery of 2.0g/kg/day.

Procedure:
• Physical exercise
The physical exercise intervention will be delivered by trained nursing staff, and started as close to the time of randomization as feasible (within 24hours of randomization). The intervention group will receive exercise sessions, for up to 20 min duration (as tolerated by patient).The implementation of physical exercise intervention will be protocolized to provide passive exercise early before weaning and shift to active exercise after weaning and also graduated resistance during each session and between daily sessions.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative changes (cross-section diameter) of rectus femoris muscle	Rectus femoris cross-sectional area (RFCSA) will be measured by B-mode ultrasonography using a 3 to 12 MHz transducer array. Patient will be positioned supine in 30° upper body elevation, with legs extended and muscles relaxed. The point that represented 60% of the distance from the anterior superior iliac spine to the superior border of the patella will be identified. The ultrasound probe will be positioned perpendicularly along the superior aspect of the right thigh and transverse images of the rectus femoris will be obtained. A copious amount of gel will be applied to minimize tissue compression. The inner echogenic line of the Rectus Femoris will be traced manually on a frozen image and RFCSA will be calculated by planimetric technique.	Up to 30 days of Surgical Intensive Care Unit stay.
Secondary	Functional capacity.	Ultrasound evaluation of the rectus femoris muscle	Up to 30 days of Surgical Intensive Care Unit stay.
Secondary	Duration of mechanical ventilation.	Duration of mechanical ventilation.	Up to 30 days of Surgical Intensive Care Unit stay.
Secondary	Length of Surgical Intensive Care Unit stay.	Length of Surgical Intensive Care Unit stay.	Up to 30 days
Secondary	Mortality rate in Surgical Intensive Care Unit	Rate of death in Surgical Intensive Care Unit	Up to 30 days
Secondary	Rate of hospital acquired infection.	Rate of hospital acquired infection.	Up to 30 days