NCT05296096Completed
PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS
PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS - a Pilot Feasibility, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
The investigators have designed a 2-center, pilot feasibility, randomized controlled trial (PROXIMUS) to determine the feasibility and safety of a larger multi center, randomized open-label trial comparing high protein combined with individualized exercise vs. standard management during the acute phase of critical illness in children. The investigators aim to determine the impact of the intervention on preservation of muscle mass; and functional status at 1 month and 6 months after randomization.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 8 Mar 2022
- Start date
- 20 Feb 2023
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Boston Children's Hospital
- NCT number
- NCT05296096
What you commit to
- Study type: Interventional
- Participants enrolled: 18
- From 20 Feb 2023 to the primary completion date, 1 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- ECMO therapy
Other illness
- Fulminant liver failure
- Kidney failure (≥KDIGO Stage 3) without replacement therapy
- High risk of refeeding syndrome
Other
- Patients unable to receive EN, PN, or who are on a specialized diet incompatible with the study intervention
- Functional Status Scale score at PICU admission \<9
- End of life/redirection of care
- Continuous neuromuscular blockade and/or bedrest is medically or surgically necessitated Participation in a conflicting interventional trial
- Inborn errors of metabolism
- High BSA burns.
Who the study is looking for
- ICU patients aged 1 year (corrected) to \<18 years
- Require mechanical ventilation (endotracheal intubation or tracheostomy, or initiation of noninvasive ventilation) in the first 72 hours of PICU admission.
- Able to consent to participate within 72 hours of initiation of mechanical ventilation initiation.
Age in the registry: 1 year to 17 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.