Clinical trialNCT05296096CompletedInterventional

PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS

SponsorBoston Children's HospitalEnrollment18MobilityMuscle LossPediatric ALLProtein

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Nilesh Mehta, MD
Faculty, Boston Children's Hospital
Principal Investigator
clinicaltrials.gov ↗
Sapna R Kudchadkar, MD, PhD
Faculty, Johns Hopkins
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Johns Hopkins Hospital
Baltimore, Maryland, United States
Boston Children'S Hospital
Boston, Massachusetts, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 20 Feb 2023
Primary completion: 1 Dec 2025
Completion: 1 Jan 2026
Last update posted: 29 May 2026
Registered enrollment: 18
Registry id: NCT05296096

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.