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NCT Number: NCT05877989

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

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.

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Key information

Conditions

Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tanta University

Tanta, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amino Acid

Drug

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

Physical exercise

Procedure

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 outcomes

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

    Time frame: Up to 30 days of Surgical Intensive Care Unit stay.

    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 outcomes

  1. Functional capacity.

    Time frame: Up to 30 days of Surgical Intensive Care Unit stay.

    Ultrasound evaluation of the rectus femoris muscle

  2. Duration of mechanical ventilation.

    Time frame: Up to 30 days of Surgical Intensive Care Unit stay.

    Duration of mechanical ventilation.

  3. Length of Surgical Intensive Care Unit stay.

    Time frame: Up to 30 days

    Length of Surgical Intensive Care Unit stay.

  4. Mortality rate in Surgical Intensive Care Unit

    Time frame: Up to 30 days

    Rate of death in Surgical Intensive Care Unit

  5. Rate of hospital acquired infection.

    Time frame: Up to 30 days

    Rate of hospital acquired infection.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 26, 2023
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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