Clinical trial

Evaluation of Effectiveness of Combining High Protein Intake With Early Physical Exercise During Critical Illness to Maintain Muscle Mass in Intensive Care Unite Patient.

Name

34750/6/21

Description

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.

Trial arms

Trial start

2021-07-01

Estimated PCD

2022-06-30

Trial end

2022-06-30

Status

Completed

Phase

Early phase I

Treatment

Amino Acid

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

Arms:

Protein and exercise group, Standard care

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.

Arms:

Protein and exercise group

Size

Primary endpoint

Quantitative changes (cross-section diameter) of rectus femoris muscle

Up to 30 days of Surgical Intensive Care Unit stay.

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "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.", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 70, 'type': 'ACTUAL'}}

Updated at

2023-05-26

1 organization

1 product

1 indication

Organization

Tanta University

Product

Amino Acid

Indication

Muscle Weakness