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

NCT05877989 | Completed Phase 4

• 1 other identifier: 34750/6/21
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Weakness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Functional capacity.

  Up to 30 days of Surgical Intensive Care Unit stay.

• Duration of mechanical ventilation.

  Up to 30 days of Surgical Intensive Care Unit stay.

• Length of Surgical Intensive Care Unit stay.

  Up to 30 days

• Mortality rate in Surgical Intensive Care Unit

  Up to 30 days

• Rate of hospital acquired infection.

  Up to 30 days

Study Arms (2)

Standard care

ACTIVE COMPARATOR

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

Protein and exercise group

ACTIVE COMPARATOR

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; Procedure: Physical exercise

Interventions

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.

Protein and exercise group; Standard care

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.

Protein and exercise group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, 31527, Egypt

Location

MeSH Terms

Conditions

Muscle Weakness

Interventions

Amino Acids; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Asmaa Badr Eldin

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 26, 2023
• Study Start: July 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)