Critical IllnessEarly Phase 1ProMoTENCT05326633
Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older ICU Survivors
A Early Phase 1 study testing MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES) in people with Critical Illness and Sarcopenia, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Older ICU survivors with ICU acquired weakness (ICUAW) are malnourished, sarcopenic, and functionally debilitated as a consequence of the high burden of comorbidities common in the elderly. Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- Critical Illness, Sarcopenia, ICU Acquired Weakness
- What is being tested?
- MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2027to 30 Oct 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 60 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LTACH admission within 72 hours
- Age ≥ 60 years old
- Prior ICU stay ≥ 2 weeks
- Able to follow commands in English
- Pre-ICU Barthel Index ≥ 70
- Able to give consent
- Able to perform physical therapy
- All four limbs intact and mobile prior to LTACH admission
Who cannot join
- Acute kidney injury with a glomerular filtration rate <15 ml/min
- Diagnosis of severe organ dysfunction including end stage liver disease or cirrhosis
- Diagnosis of active cancer
- Severe functional impairment or physical impairment to rehabilitation
- Liver function tests >2.5x normal limits
- Chronic dementia or cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
U of Maryland, Baltimore, Professional Schools IRB
Baltimore, Maryland, 21201
Avelino C Verceles, MD, MS, 410-328-8141, avercele@medicine.umaryland.edu
About this study
Official title: Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older Survivors of Critical Illness
Older ICU survivors with ICU acquired weakness (ICUAW) are malnourished, sarcopenic, and functionally debilitated as a consequence of the high burden of comorbidities common in the elderly. To address the sequalae of critical illnesses, the investigators will perform a trial incorporating an intervention that combines mobility-based physical rehabilitation (MRP), high protein supplementation (HPRO), and neuromuscular electric stimulation (NMES). The investigators will then assess both clinical and functional outcomes and determine the relationship of disability with systemic inflammation.
Read the detailed description
Annually, nearly 3 million patients ≥ 65 years old are admitted to intensive care units (ICUs) nationwide, 20% of whom experience a long, protracted ICU stay resulting in muscle deconditioning, atrophy, inflammation, and functional disability necessitating transfer from the ICU to a long term acute care hospitals (LTACH). In the LTACH exacerbations of chronic comorbidities and the cycle of prolonged bed rest, ongoing inflammation and malnutrition often leads to continued functional disability, immobility, prolonged mechanical ventilation and increased one-year mortality of up to 25%. After a patient has survived critical illness and is transferred to an LTACH facility, one of the major challenges of their continued care is how to address - and ameliorate - their profound physical and functional deficits.
To address these sequalae of chronic critical illness, the investigators will perform a trial incorporating an intervention that combines mobility-based physical rehabilitation (MRP), high protein supplementation (HPRO) and neuromuscular electric stimulation (NMES) to assess both clinical and functional outcomes and to determine the relationship of disability with systemic inflammation. The investigators will prospectively randomize patient to receive our multicomponent intervention or usual care and assess the outcomes of functional mobility, change in muscle mass and discharge disposition. Additionally, the investigators will determine the effects of our intervention on inflammatory cytokine profiles to determine to what degree systemic inflammation mediates clinical recovery.
- Conditions
- Critical Illness, Sarcopenia, ICU Acquired Weakness
- Being tested
- MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)
- Keywords
- ICU Acquired Weakness, Critical Care, Long Term Acute Care Hospital, Protein, Neuromuscular electric stimulation, Physical Rehabilitation, Geriatric population
- Medical subject headings
- Critical Illness, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)Combination product
Mobility-based physical rehabilitation sessions performed 5 times/week by a study PT to provide strength and cardiopulmonary endurance training. High whey protein shakes prescribed to a total intake of 1.6-1.8 g/kg/d in 2 divided doses based on caloric needs. 2 x 30-minute lower extremity electric stimulation sessions/day, 5 times/wk performed by study PT.
| Study group | Role | What they receive |
|---|---|---|
| UC only | No intervention | LTACH control group receiving usual care (UC) only. |
| MRP+HPRO+NMES+UC | Active comparator | LTACH group receiving mobility based rehabilitation (MRP) + neuromuscular electric stimulation (NMES) + high protein supplementation (HPRO) + usual care (UC) Receives: Combination Product: MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle mass
Muscle mass will be measured by lower extremity muscle CT scans to calculate muscle volume and cross sectional area.
Measured: Days 0 to 14 to 28
Change in Muscle strength
Handgrip strength obtained using a hand grip dynamometer and manual muscle testing using hand held dynamometer
Measured: Days 0, 7, 14, 21 and 28
Change in Systemic Inflammation
Quantitative analysis of CRP, IFN-γ, IL-1α, IL-1β, IL-6, and IL-8.
Measured: Days 0, 7, 14, 21 and 28
Secondary outcomes (6)
Change in Functional status - SPPB
Functional status will be assessed by using the Short Physical Performance Battery (SPPB)
Measured: Days 0, 7, 14, 21 and 28
Change in Functional status - FSS-ICU
Functional status will be assessed by using the Functional Status Score in the ICU (FSS-ICU).
Measured: Days 0, 7, 14, 21 and 28
Change in Mobility status - ICU mobility Scale
Mobility status will be assessed weekly using the 1-item ICU Mobility Scale weekly in those physically capable.
Measured: Days 0, 7, 14, 21 and 28
Change in Mobility status - 6 minute walk distance
Mobility status will be assessed weekly using the total 6 Minute Walk distance in those physically capable.
Measured: Days 0, 7, 14, 21 and 28
Change in Mobility status - gait speed
Mobility status will be assessed weekly using gait speed in those physically capable.
Measured: Days 0, 7, 14, 21 and 28
Discharge disposition (LTACH to home, nursing home, acute rehabilitation, readmission, or death)
Discharge disposition from the LTACH to home, nursing home, acute rehabilitation, readmission, or death)
Measured: up to or after Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start1 Mar 2027 (estimated)
- Primary completion30 Jan 2029 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avelino Verceles, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326633
- Sponsor's protocol ID
- HP-00083098
- Acronym
- ProMoTE
- Status last verified
- Apr 2026
- First submitted
- 7 Feb 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older Survivors of Critical Illness
- ClinicalTrials.gov ID
- NCT05326633
- Acronym / sponsor ID
- ProMoTE / HP-00083098
- Conditions
- Critical Illness, Sarcopenia, ICU Acquired Weakness
- Keywords
- ICU Acquired Weakness, Critical Care, Long Term Acute Care Hospital, Protein, Neuromuscular electric stimulation, Physical Rehabilitation, Geriatric population
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 30 Jan 2029 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 13 Apr 2022 (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.
Older ICU survivors with ICU acquired weakness (ICUAW) are malnourished, sarcopenic, and functionally debilitated as a consequence of the high burden of comorbidities common in the elderly. To address the sequalae of critical illnesses, the investigators will perform a trial incorporating an intervention that combines mobility-based physical rehabilitation (MRP), high protein supplementation (HPRO), and neuromuscular electric stimulation (NMES). The investigators will then assess both clinical and functional outcomes and determine the relationship of disability with systemic inflammation.
Detailed description
Annually, nearly 3 million patients ≥ 65 years old are admitted to intensive care units (ICUs) nationwide, 20% of whom experience a long, protracted ICU stay resulting in muscle deconditioning, atrophy, inflammation, and functional disability necessitating transfer from the ICU to a long term acute care hospitals (LTACH). In the LTACH exacerbations of chronic comorbidities and the cycle of prolonged bed rest, ongoing inflammation and malnutrition often leads to continued functional disability, immobility, prolonged mechanical ventilation and increased one-year mortality of up to 25%. After a patient has survived critical illness and is transferred to an LTACH facility, one of the major challenges of their continued care is how to address - and ameliorate - their profound physical and functional deficits.
To address these sequalae of chronic critical illness, the investigators will perform a trial incorporating an intervention that combines mobility-based physical rehabilitation (MRP), high protein supplementation (HPRO) and neuromuscular electric stimulation (NMES) to assess both clinical and functional outcomes and to determine the relationship of disability with systemic inflammation. The investigators will prospectively randomize patient to receive our multicomponent intervention or usual care and assess the outcomes of functional mobility, change in muscle mass and discharge disposition. Additionally, the investigators will determine the effects of our intervention on inflammatory cytokine profiles to determine to what degree systemic inflammation mediates clinical recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UC only | No intervention | –LTACH control group receiving usual care (UC) only. |
| MRP+HPRO+NMES+UC | Active comparator | Combination Product: MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)LTACH group receiving mobility based rehabilitation (MRP) + neuromuscular electric stimulation (NMES) + high protein supplementation (HPRO) + usual care (UC) |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- LTACH admission within 72 hours
- Age ≥ 60 years old
- Prior ICU stay ≥ 2 weeks
- Able to follow commands in English
- Pre-ICU Barthel Index ≥ 70
Key exclusion criteria (6 listed)
- Acute kidney injury with a glomerular filtration rate <15 ml/min
- Diagnosis of severe organ dysfunction including end stage liver disease or cirrhosis
- Diagnosis of active cancer
- Severe functional impairment or physical impairment to rehabilitation
- Liver function tests >2.5x normal limits
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 |
|---|---|---|
| MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)Mobility-based physical rehabilitation sessions performed 5 times/week by a study PT to provide strength and cardiopulmonary endurance training. High whey protein shakes prescribed to a total intake of 1.6-1.8 g/kg/d in 2 divided doses based on caloric needs. 2 x 30-minute lower extremity electric stimulation sessions/day, 5 times/wk performed by study PT. | Combination product | MRP+HPRO+NMES+UC |
Primary outcome
Change in Muscle mass
Time frame: Days 0 to 14 to 28
Muscle mass will be measured by lower extremity muscle CT scans to calculate muscle volume and cross sectional area.
Change in Muscle strength
Time frame: Days 0, 7, 14, 21 and 28
Handgrip strength obtained using a hand grip dynamometer and manual muscle testing using hand held dynamometer
Change in Systemic Inflammation
Time frame: Days 0, 7, 14, 21 and 28
Quantitative analysis of CRP, IFN-γ, IL-1α, IL-1β, IL-6, and IL-8.
6 secondary outcomes
Change in Functional status - SPPB
Time frame: Days 0, 7, 14, 21 and 28
Change in Functional status - FSS-ICU
Time frame: Days 0, 7, 14, 21 and 28
Change in Mobility status - ICU mobility Scale
Time frame: Days 0, 7, 14, 21 and 28
Change in Mobility status - 6 minute walk distance
Time frame: Days 0, 7, 14, 21 and 28
Change in Mobility status - gait speed
Time frame: Days 0, 7, 14, 21 and 28
Discharge disposition (LTACH to home, nursing home, acute rehabilitation, readmission, or death)
Time frame: up to or after Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MRP and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES) in people with Critical Illness and Sarcopenia, run by University of Maryland, Baltimore at 1 site in United States.
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 8 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: opening soon, as of the sponsor's last update on 6 May 2026. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Avelino C Verceles, M.D., M.S. (410-328-8141, avercele@medicine.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Muscle mass (time frame: Days 0 to 14 to 28). The study lists 3 primary outcomes in all. 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 6 May 2026.