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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Muscle Weakness

Intervention / Treatment
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* Drug: Amino Acid
* Procedure: Physical exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care<br>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. | Drug: Amino Acid<br>* Amino acid enteral and/or parenteral nutrition either enteral or parenteral to target a total protein delivery of 2.0g/kg/day.<br>|
| Active Comparator: Protein and exercise group<br>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. | Drug: Amino Acid<br>* Amino acid enteral and/or parenteral nutrition either enteral or parenteral to target a total protein delivery of 2.0g/kg/day.<br>Procedure: Physical exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity. | Ultrasound evaluation of the rectus femoris muscle | Up to 30 days of Surgical Intensive Care Unit stay. | 
| Duration of mechanical ventilation. | Duration of mechanical ventilation. | Up to 30 days of Surgical Intensive Care Unit stay. | 
| Length of Surgical Intensive Care Unit stay. | Length of Surgical Intensive Care Unit stay. | Up to 30 days | 
| Mortality rate in Surgical Intensive Care Unit | Rate of death in Surgical Intensive Care Unit | Up to 30 days | 
| Rate of hospital acquired infection. | Rate of hospital acquired infection. | Up to 30 days |