Back to resultsEvaluation of Effectiveness of Combining High Protein Intake With Early Physical Exercise During Critical Illness
Primary Purpose
Muscle Weakness
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Amino Acid
Physical exercise
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Weakness
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
Sites / Locations
- Tanta University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard care
Protein and exercise group
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Functional capacity.
Ultrasound evaluation of the rectus femoris muscle
Duration of mechanical ventilation.
Duration of mechanical ventilation.
Length of Surgical Intensive Care Unit stay.
Length of Surgical Intensive Care Unit stay.
Mortality rate in Surgical Intensive Care Unit
Rate of death in Surgical Intensive Care Unit
Rate of hospital acquired infection.
Rate of hospital acquired infection.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05877989
Brief Title
Evaluation of Effectiveness of Combining High Protein Intake With Early Physical Exercise During Critical Illness
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
Active Comparator
Arm 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.
Arm Title
Protein and exercise group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Amino Acid
Intervention Description
Amino acid enteral and/or parenteral nutrition either enteral or parenteral to target a total protein delivery of 2.0g/kg/day.
Intervention Type
Procedure
Intervention Name(s)
Physical exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quantitative changes (cross-section diameter) of rectus femoris muscle
Description
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.
Time Frame
Up to 30 days of Surgical Intensive Care Unit stay.
Secondary Outcome Measure Information:
Title
Functional capacity.
Description
Ultrasound evaluation of the rectus femoris muscle
Time Frame
Up to 30 days of Surgical Intensive Care Unit stay.
Title
Duration of mechanical ventilation.
Description
Duration of mechanical ventilation.
Time Frame
Up to 30 days of Surgical Intensive Care Unit stay.
Title
Length of Surgical Intensive Care Unit stay.
Description
Length of Surgical Intensive Care Unit stay.
Time Frame
Up to 30 days
Title
Mortality rate in Surgical Intensive Care Unit
Description
Rate of death in Surgical Intensive Care Unit
Time Frame
Up to 30 days
Title
Rate of hospital acquired infection.
Description
Rate of hospital acquired infection.
Time Frame
Up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Tanta University
City
Tanta
ZIP/Postal Code
31527
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available upon reasonable request from the corresponding author for one year after study completion.
Learn more about this trial
Evaluation of Effectiveness of Combining High Protein Intake With Early Physical Exercise During Critical Illness
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