Cardiopulmonary Fitness and Health-Related Quality of Life in Children and Adolescents With Type … (NCT07728435) | Clinical Trial Compass
CompletedNot Applicable
Cardiopulmonary Fitness and Health-Related Quality of Life in Children and Adolescents With Type 1 Diabetes (FIT-T1D)
France214 participantsStarted 2025-12-04
Plain-language summary
Children and adolescents with type 1 diabetes (T1D) are at risk of a sedentary lifestyle, as this chronic disease may lead patients into a vicious cycle of deconditioning, resulting in reduced physical activity levels and increased cardiovascular risk.
Our previous studies have demonstrated impaired exercise capacity and reduced quality of life, associated with physical deconditioning and increased sedentary behavior in children and adolescents with other chronic diseases.
This study aims to evaluate cardiopulmonary fitness, physical activity and health-related quality of life in children with type 1 diabetes aged 6 - 17 years and to compare these outcomes with healthy peers. We also aim to evaluate the parameters associated with cardiopulmonary fitness in this population.
Who can participate
Age range
6 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient aged from 6 to 17 years with a type 1 diabetes (diagnosed at least 1 month before)
Exclusion Criteria:
* Patient with a congenital heart disease or any significative comorbidity that could reduce functional capacities
* Patient with a contraindication to the CPET
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is completed and measured VO2max — cardiopulmonary fitness — in kids and teens with Type 1 diabetes, so could you help me understand what the findings might mean for my child's exercise routine or diabetes management plan?
2Since this trial has already finished and wasn't testing a new treatment but rather measuring fitness and quality of life, would the results change any recommendations you'd make for my child right now?
3The study looked at health-related quality of life alongside physical fitness in children and adolescents with Type 1 diabetes — are there specific aspects of my child's quality of life or fitness level you think we should be monitoring more closely based on this kind of research?
4Because this was an observational-style study rather than a treatment trial, are there any exercise or lifestyle programs for kids with Type 1 diabetes that are backed by similar evidence that you'd recommend we look into?
5Could the data from a study like this one help us set realistic fitness goals for my child while keeping their blood sugar management safe during physical activity?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
VO2max
Timeframe: Measured at the baseline study visit (single cross-sectional assessment)