High Protein Diet + Exercise for Muscle Loss
(PROXIMUS Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment High Protein Diet + Exercise for Muscle Loss?
Research shows that high protein diets and exercise can help maintain muscle mass in older adults and those experiencing muscle loss due to conditions like sarcopenia (age-related muscle loss) and cachexia (muscle wasting). Protein supplements, especially when combined with resistance exercise, have been found to improve muscle mass and strength.12345
Is a high protein diet with exercise safe for humans?
How does the High Protein Diet + Exercise treatment differ from other treatments for muscle loss?
This treatment is unique because it combines a high protein diet with individualized exercise prescriptions, which may enhance muscle mass and function more effectively than protein or exercise alone. The focus on personalized exercise plans and specific protein intake timing and dosage sets it apart from standard approaches.89101112
What is the purpose of this trial?
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.
Research Team
Nilesh Mehta, MD
Principal Investigator
Faculty, Boston Children's Hospital
Sapna R Kudchadkar, MD
Principal Investigator
Faculty, Johns Hopkins
Eligibility Criteria
This trial is for children aged 1 to under 18 years who are on mechanical ventilation within the first 48 hours of PICU admission and expected to stay on it. They must be able to consent within this period. It's not for those with liver failure, certain medical conditions requiring bedrest, high-risk burns, severe kidney issues without therapy, or incompatible diets.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive high protein combined with individualized exercise or standard management during the acute phase of critical illness
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments at 1 and 6 months
Treatment Details
Interventions
- Protein dosage and rehabilitation team delivered exercise prescription
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor
Johns Hopkins University
Collaborator