Muscle WeaknessPhase 4NCT05877989
Evaluation of Effectiveness of Combining High Protein Intake With Early Physical Exercise During Critical Illness
A Phase 4 study testing Amino Acid and Physical exercise in people with Muscle Weakness, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- Amino Acid and Physical exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 30 Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Muscle Weakness
- Being tested
- Amino Acid, Physical exercise
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino AcidDrug
Amino acid enteral and/or parenteral nutrition either enteral or parenteral to target a total protein delivery of 2.0g/kg/day.
Physical exerciseProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Amino Acid; Procedure: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days of Surgical Intensive Care Unit stay.
Secondary outcomes (5)
Functional capacity.
Ultrasound evaluation of the rectus femoris muscle
Measured: Up to 30 days of Surgical Intensive Care Unit stay.
Duration of mechanical ventilation.
Duration of mechanical ventilation.
Measured: Up to 30 days of Surgical Intensive Care Unit stay.
Length of Surgical Intensive Care Unit stay.
Length of Surgical Intensive Care Unit stay.
Measured: Up to 30 days
Mortality rate in Surgical Intensive Care Unit
Rate of death in Surgical Intensive Care Unit
Measured: Up to 30 days
Rate of hospital acquired infection.
Rate of hospital acquired infection.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Jul 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Badr Eldin, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877989
- Sponsor's protocol ID
- 34750/6/21
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 26 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the corresponding author for one year after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05877989
- Acronym / sponsor ID
- 34750/6/21
- Conditions
- Muscle Weakness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Drug: Amino AcidPatients 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. |
| Protein and exercise group | Active comparator | Drug: Amino Acid, Procedure: Physical exercisepatients 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amino AcidAmino acid enteral and/or parenteral nutrition either enteral or parenteral to target a total protein delivery of 2.0g/kg/day. | Drug | Protein and exercise group, Standard care |
| Physical exerciseThe 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. | Procedure or surgery | Protein and exercise group |
Primary outcome
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.
5 secondary outcomes
Functional capacity.
Time frame: Up to 30 days of Surgical Intensive Care Unit stay.
Duration of mechanical ventilation.
Time frame: Up to 30 days of Surgical Intensive Care Unit stay.
Length of Surgical Intensive Care Unit stay.
Time frame: Up to 30 days
Mortality rate in Surgical Intensive Care Unit
Time frame: Up to 30 days
Rate of hospital acquired infection.
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the corresponding author for one year after study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amino Acid and Physical exercise in people with Muscle Weakness, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative changes (cross-section diameter) of rectus femoris muscle (time frame: Up to 30 days of Surgical Intensive Care Unit stay.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.