RECRUITING

PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS

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Conditions

Muscle LossProteinMobilityPediatric ALLexercisemechanical ventilationoutcomenutrition

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS - a Pilot Feasibility, Randomized Controlled Trial

Quick Facts

Study Start:2023-02-20
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05296096

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. ICU patients aged 1 year (corrected) to \<18 years
  2. 2. Require mechanical ventilation (endotracheal intubation or tracheostomy, or initiation of noninvasive ventilation) in the first 72 hours of PICU admission.
  3. 3. Able to consent to participate within 72 hours of initiation of mechanical ventilation initiation.
  1. * Patients unable to receive EN, PN, or who are on a specialized diet incompatible with the study intervention
  2. * Fulminant liver failure
  3. * Kidney failure (≥KDIGO Stage 3) without replacement therapy
  4. * Functional Status Scale score at PICU admission \<9
  5. * End of life/redirection of care
  6. * ECMO therapy
  7. * Continuous neuromuscular blockade and/or bedrest is medically or surgically necessitated Participation in a conflicting interventional trial
  8. * High risk of refeeding syndrome
  9. * Inborn errors of metabolism
  10. * High BSA burns.

Contacts and Locations

Study Contact

Nilesh M. Mehta, MD
CONTACT
6173557327
nilesh.mehta@childrens.harvard.edu
Lori Bechard, RD, PhD
CONTACT
6173557327
lori.bechard@childrens.harvard.edu

Principal Investigator

Nilesh Mehta, MD
PRINCIPAL_INVESTIGATOR
Faculty, Boston Children's Hospital
Sapna R Kudchadkar, MD, PhD
PRINCIPAL_INVESTIGATOR
Faculty, Johns Hopkins

Study Locations (Sites)

Johns Hopkins Hospital
Baltimore, Maryland, 21218
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

  • Nilesh Mehta, MD, PRINCIPAL_INVESTIGATOR, Faculty, Boston Children's Hospital
  • Sapna R Kudchadkar, MD, PhD, PRINCIPAL_INVESTIGATOR, Faculty, Johns Hopkins

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-20
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2023-02-20
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • protein
  • exercise
  • mechanical ventilation
  • outcome
  • nutrition

Additional Relevant MeSH Terms

  • Muscle Loss
  • Protein
  • Mobility
  • Pediatric ALL