Critical IllnessProMob-ICUNCT04099108
Effect of Combined IV Bolus Amino Acid Supplementation and Mobilisation on Skeletal Muscle During the First 10 Days in the ICU: A RCT
A study testing Combined cycle ergometry and bolus amino acid supplementation in people with Critical Illness, run by University of Stellenbosch at 1 site in South Africa.
Trial summary
A single-centre, two-arm, parallel randomised controlled trial (RCT) to compare the combined effect of early intravenous bolus amino acid supplementation and mobilisation versus standard of care on changes in muscle mass over the first week in ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Combined cycle ergometry and bolus amino acid supplementation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Africa
- Study dates
- 24 May 2021to 31 Dec 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (≥18 years) admitted to medical/surgical ICU of Tygerberg Academic Hospital (TBH)
- Expected length of mechanical- or non-invasive ventilation > 48 hours
- Receiving enteral (EN) and/or parenteral nutrition (PN) as per standard care and for a minimum of 5 days
- Expected ICU length of stay of 7 days
Who cannot join
- Spinal cord lesion or intracranial process associated with muscle weakness
- Acute/chronic degenerative neuromuscular condition
- Fulminant hepatic failure/severe chronic liver disease (MELD score ≥20) or renal failure (based on KDIGO) not on Renal Replacement Therapy
- Untreated thrombosis, or thrombosis where therapeutic levels of anticoagulants have not been reached at the time of inclusion
- Any condition deemed inappropriate by the overseeing doctor- such as precautions or contraindications related to the movement as a result of trauma and/or surgery to the spine, pelvis or lower limbs, or haemodynamic instability.
- Other: imminent death or withdrawal of treatment, pregnancy, lower limb amputation/s or fractures, readmission after previous randomisation, long-term corticosteroid therapy, morbidly obese (BMI ≥ 40kg/m2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Combined Intravenous, Bolus Amino Acid Supplementation and Mobilisation on Skeletal Muscle During the Acute Phase of Critical Illness: a Randomised Controlled Trial.
A single-centre, two-arm, parallel randomised controlled trial (RCT) to compare the combined effect of early intravenous bolus amino acid supplementation and mobilisation versus standard of care on changes in muscle mass over the first week in ICU. Half of study participants will receive the study intervention (an intravenous bolus amino acid supplement combined with in-bed cycling), while the other half will receive standard of care only.
Read the detailed description
Critical illness survivors often suffer from severe muscle mass depletion and a profound long-term functional impairment. Hence effective strategies, or a combination of strategies, are needed to reduce skeletal muscle wasting during critical illness. Although amino acids and mobilisation are both known to stimulate the mechanistic target of rapamycin pathway (MTOR) pathway for muscle protein synthesis in healthy adults, there are no trials to date investigating the combined approach of combined cycle ergometry and bolus amino acid supplementation on muscle accretion in the ICU.
- Conditions
- Critical Illness
- Being tested
- Combined cycle ergometry and bolus amino acid supplementation
- Keywords
- critical illness, amino acids, mobilisation, muscle
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined cycle ergometry and bolus amino acid supplementationCombination product
A 4-hour intravenous amino acid bolus combined with 45 minutes of cycle ergometry initiated within 1 hour of initiation of the amino acid supplement, starting on ICU Day 3-4 and given daily for a minimum of 5 days, and until latest Day 10 in the ICU.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Combined cycle ergometry and bolus amino acid supplementation, along with standard of care Receives: Combination Product: Combined cycle ergometry and bolus amino acid supplementation |
| Control | No intervention | Standard of care only (standard care nutrition guided by the ESPEN 2019 guidelines, and routine mobilisation performed as per the local unit's protocols and practice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vastus lateralis myofiber cross-sectional area (biopsy) from pre- to post-intervention.
Measured: Pre-intervention biopsy performed 1 day before initiating the combined study intervention (on average day 2). Post-intervention biopsy performed after completing 5-days of the combined study intervention (on average day 8).
Change in rectus femoris muscle cross-sectional area (ultrasound) from pre- to post-intervention
Measured: Pre-intervention biopsy performed 1 day before initiating the combined study intervention (on average day 2). Post-intervention biopsy performed after completing 5-days of the combined study intervention (on average day 8).
Secondary outcomes (6)
Change in protein-to-DNA ratio as a secondary marker of muscle mass
Obtained from muscle biopsy of the musculus vastus lateralis of the quadriceps
Measured: From pre- to post-intervention
Signalling pathways for muscle protein synthesis and breakdown
Key proteins regulating muscle protein synthesis and breakdown, including markers of autophagy
Measured: From pre- to post-intervention
Change in muscle mass (rectus femoris muscle CSA) and quality (RF muscle echogenicity) over shorter intervals from pre-intervention until study exit (Pre-intervention, Day 5, 7, 10, study exit)
Measured: Over shorter intervals from pre-intervention until study exit, if possible (Pre-intervention, Day 5, 7, 10, study exit)
Change in plasma amino acid levels (intervention group only)
Based on plasma samples obtained on ICU day 5
Measured: Plasma samples will be obtained at 3 time intervals, (1) prior to amino acid infusion (T0), (2) 4 hours post amino acid infusion (T1), and (3) 24 hours post amino acid infusion (T2)
Muscle strength
Overall muscle strength will be evaluated using the Medical Research Council (MRC) sum-score via standardised "manual muscle testing" with each of 12 muscle groups assessed using a 6-point MRC scale and summed to a total score (range: 0 - 60)
Measured: Performed upon ICU awakening, and repeated on ICU discharge and study exit (day 28 or hospital discharge if earlier)
Physical capability
Based on 6-minute walking test
Measured: Performed on study exit only (day 28, or day of hospital discharge if discharged earlier)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start24 May 2021
- Primary completion9 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Stellenbosch
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Kabi, University of the Western Cape
- Responsible party
- Principal investigator, Prof Renee Blaauw, University of Stellenbosch
- Investigators
- Lizl Veldsman, M Nutr, Principal investigator, University of Stellenbosch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099108
- Sponsor's protocol ID
- VAMI-001-IP4
- Other IDs
- VAMI-001-IP4
- Acronym
- ProMob-ICU
- Status last verified
- Jan 2022
- First submitted
- 18 Sep 2019
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Veldsman L, Lupton-Smith A, Richards GA, Blaauw R: Muscle ultrasound: a reliable bedside tool for dietitians to monitor muscle mass, South Afr J Clin Nutr. 2024:37(3): 125 - 130. doi: 10.1080/16070658.2024.2363707.
Veldsman L, Richards GA, Lombard C, Blaauw R. Course of measured energy expenditure over the first 10 days of critical illness: A nested prospective study in an adult surgical ICU. Clin Nutr ESPEN. 2025 Feb;65:227-235. doi: 10.1016/j.clnesp.2024.11.009. Epub 2024 Nov 16.
PubMed 39551349
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combined Intravenous, Bolus Amino Acid Supplementation and Mobilisation on Skeletal Muscle During the Acute Phase of Critical Illness: a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT04099108
- Acronym / sponsor ID
- ProMob-ICU / VAMI-001-IP4
- Conditions
- Critical Illness
- Keywords
- critical illness, amino acids, mobilisation, muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of StellenboschUniversity, hospital or other
- Collaborators
- Fresenius Kabi, University of the Western Cape
- Study start
- 24 May 2021 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Sep 2019 (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.
A single-centre, two-arm, parallel randomised controlled trial (RCT) to compare the combined effect of early intravenous bolus amino acid supplementation and mobilisation versus standard of care on changes in muscle mass over the first week in ICU. Half of study participants will receive the study intervention (an intravenous bolus amino acid supplement combined with in-bed cycling), while the other half will receive standard of care only.
Detailed description
Critical illness survivors often suffer from severe muscle mass depletion and a profound long-term functional impairment. Hence effective strategies, or a combination of strategies, are needed to reduce skeletal muscle wasting during critical illness. Although amino acids and mobilisation are both known to stimulate the mechanistic target of rapamycin pathway (MTOR) pathway for muscle protein synthesis in healthy adults, there are no trials to date investigating the combined approach of combined cycle ergometry and bolus amino acid supplementation on muscle accretion in the ICU.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Combination Product: Combined cycle ergometry and bolus amino acid supplementationCombined cycle ergometry and bolus amino acid supplementation, along with standard of care |
| Control | No intervention | –Standard of care only (standard care nutrition guided by the ESPEN 2019 guidelines, and routine mobilisation performed as per the local unit's protocols and practice) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient (≥18 years) admitted to medical/surgical ICU of Tygerberg Academic Hospital (TBH)
- Expected length of mechanical- or non-invasive ventilation > 48 hours
- Receiving enteral (EN) and/or parenteral nutrition (PN) as per standard care and for a minimum of 5 days
- Expected ICU length of stay of 7 days
Key exclusion criteria (6 listed)
- Spinal cord lesion or intracranial process associated with muscle weakness
- Acute/chronic degenerative neuromuscular condition
- Fulminant hepatic failure/severe chronic liver disease (MELD score ≥20) or renal failure (based on KDIGO) not on Renal Replacement Therapy
- Untreated thrombosis, or thrombosis where therapeutic levels of anticoagulants have not been reached at the time of inclusion
- Any condition deemed inappropriate by the overseeing doctor- such as precautions or contraindications related to the movement as a result of trauma and/or surgery to the spine, pelvis or lower limbs, or haemodynamic instability.
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 |
|---|---|---|
| Combined cycle ergometry and bolus amino acid supplementationA 4-hour intravenous amino acid bolus combined with 45 minutes of cycle ergometry initiated within 1 hour of initiation of the amino acid supplement, starting on ICU Day 3-4 and given daily for a minimum of 5 days, and until latest Day 10 in the ICU. | Combination product | Intervention |
Primary outcome
Change in vastus lateralis myofiber cross-sectional area (biopsy) from pre- to post-intervention.
Time frame: Pre-intervention biopsy performed 1 day before initiating the combined study intervention (on average day 2). Post-intervention biopsy performed after completing 5-days of the combined study intervention (on average day 8).
Change in rectus femoris muscle cross-sectional area (ultrasound) from pre- to post-intervention
Time frame: Pre-intervention biopsy performed 1 day before initiating the combined study intervention (on average day 2). Post-intervention biopsy performed after completing 5-days of the combined study intervention (on average day 8).
6 secondary outcomes
Change in protein-to-DNA ratio as a secondary marker of muscle mass
Time frame: From pre- to post-intervention
Signalling pathways for muscle protein synthesis and breakdown
Time frame: From pre- to post-intervention
Change in muscle mass (rectus femoris muscle CSA) and quality (RF muscle echogenicity) over shorter intervals from pre-intervention until study exit (Pre-intervention, Day 5, 7, 10, study exit)
Time frame: Over shorter intervals from pre-intervention until study exit, if possible (Pre-intervention, Day 5, 7, 10, study exit)
Change in plasma amino acid levels (intervention group only)
Time frame: Plasma samples will be obtained at 3 time intervals, (1) prior to amino acid infusion (T0), (2) 4 hours post amino acid infusion (T1), and (3) 24 hours post amino acid infusion (T2)
Muscle strength
Time frame: Performed upon ICU awakening, and repeated on ICU discharge and study exit (day 28 or hospital discharge if earlier)
Physical capability
Time frame: Performed on study exit only (day 28, or day of hospital discharge if discharged earlier)
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 3 Dec 2025.
- Results publicationVeldsman L, Lupton-Smith A, Richards GA, Blaauw R: Muscle ultrasound: a reliable bedside tool for dietitians to monitor muscle mass, South Afr J Clin Nutr. 2024:37(3): 125 - 130. doi: 10.1080/16070658.2024.2363707.
- Results publication: PubMed 39551349Veldsman L, Richards GA, Lombard C, Blaauw R. Course of measured energy expenditure over the first 10 days of critical illness: A nested prospective study in an adult surgical ICU. Clin Nutr ESPEN. 2025 Feb;65:227-235. doi: 10.1016/j.clnesp.2024.11.009. Epub 2024 Nov 16.
- Individual participant dataSharing planned: No
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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.
Lizl Veldsman, M Nutr principal investigator
University of Stellenbosch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined cycle ergometry and bolus amino acid supplementation in people with Critical Illness, run by University of Stellenbosch at 1 site in South Africa.
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 4 inclusion and 6 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 3 Dec 2025. 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 South Africa. 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.
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?
Change in vastus lateralis myofiber cross-sectional area (biopsy) from pre- to post-intervention. (time frame: Pre-intervention biopsy performed 1 day before initiating the combined study intervention (on average day 2). Post-intervention biopsy performed after completing 5-days of the combined study intervention (on average day 8).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04099108, which also lists 2 linked publications.
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 3 Dec 2025.