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

Tanta University

Status and phase: Completed; Phase 4

Conditions: Muscle Weakness

Treatments: Procedure: Physical exercise; Drug: Amino Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05877989

34750/6/21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Standard care

Active Comparator group

Description:

Patients will receive usual care in Intensive Care Unit (prescription of a standard nutrition formula (at approximately 20 -25 kcal/ kg/day and protein intake 1.2 g/kg/day) once patients are hemodynamically stable.

Treatment:

Drug: Amino Acid

Protein and exercise group

Active Comparator group

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 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.

Treatment:

Procedure: Physical exercise

Drug: Amino Acid