FIT-ATOMIC Exercise Feasibility Trial for Youth with MS
This study is looking at whether a home-based exercise program is a good way to help young people (ages 11-25) with Multiple Sclerosis (MS) or clinically isolated syndrome. We want to see if it's possible to do a larger study on exercise as a way to improve health for this group. Participants will be randomly assigned to either an Exercise Training group or a Mobility and Flexibility Training group for 20 weeks. We will compare how these groups affect physical activity, mental well-being, and other health measures. The main goals are to see how many people join, how well the exercise program is delivered, and how many people complete the study.
- Study design
- This is a randomized controlled feasibility trial involving about 40 participants. Participants will be assigned by chance to one of two groups.
- What's involved
- You would participate in three weekly exercise sessions for 20 weeks. Assessments, including clinical exams, brain MRI, eye tracking, cognitive testing, blood draws, and questionnaires, will happen at the beginning and after 20 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures participant drop-out rate from enrollment to the end of the study, which is 20 weeks after the intervention begins.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
FIT-ATOMIC Exercise Feasibility Trial
At a glance
Conditions
Where it's being run
4 sites across 4 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Participant accrual rateFrom enrollment to the end of study
Number of participants enrolled per year
- Fidelity of delivering the interventionFrom enrollment to the end of intervention at 20 weeks
ASPIRE fidelity coaching checklist. This measure assesses the fidelity with which study coaches deliver the intervention during calls with participants. Participants are scored on a scale from 0 to 2, based on the extent to which the intervention components are covered: 0: Did not cover - The intervention component was not addressed during the call. 1. Partially covered - The intervention component was addressed to some extent, but not fully. 2. Fully covered - The intervention component was fully addressed, meeting the intended criteria for delivery. A higher score reflects a more complete and accurate delivery of the intervention as planned.
- Participant drop-out rateFrom enrollment to the end of study
Percentage of total patients that dropped out of study.
- Adverse event rateFrom enrollment to the end of study
Number of adverse events per total participants
- Completion rate of study measuresFrom enrollment to the end of study
Percentage of total patients that completed the study measures.