Evaluation of Effectiveness of Combining High Protein Intake With Early Physical Exercise During Critical Illness
NCT ID: NCT05877989
Last Updated: 2023-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2021-07-01
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard care
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.
Amino Acid
Amino acid enteral and/or parenteral nutrition either enteral or parenteral to target a total protein delivery of 2.0g/kg/day.
Protein and exercise group
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.
Amino Acid
Amino acid enteral and/or parenteral nutrition either enteral or parenteral to target a total protein delivery of 2.0g/kg/day.
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.
Interventions
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Amino Acid
Amino acid enteral and/or parenteral nutrition either enteral or parenteral to target a total protein delivery of 2.0g/kg/day.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Asmaa Badr Eldin
Doctor Asmaa Badr Eldin
Locations
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Tanta University
Tanta, , Egypt
Countries
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Other Identifiers
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34750/6/21
Identifier Type: -
Identifier Source: org_study_id
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