Contribution of the Evaluation of Body Composition by Connected Scale in the Effectiveness of a R… (NCT06119594) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Contribution of the Evaluation of Body Composition by Connected Scale in the Effectiveness of a Reconditioning Program Through Physical Activity Adapted for Patients Suffering From Chronic Diseases
France90 participantsStarted 2024-08-27
Plain-language summary
The goal of this interventional study is to evaluate the impact of the use of a connected impedance scale on the physical and mental quality of life of patients suffering from chronic diseases and participating in a physical activity rehabilitation program. The main objective is to know if a regular monitoring of the evolution of body composition parameters recorded by the connected scale would allow patients participating in the Physical Activity rehabilitation program at Hôtel-Dieu to follow in real time the effects of such program, not on weight itself but on body composition, and that this would contribute to a better perception of physical and mental quality of life at the end of the program 90 Participants will be randomized in two groups :
* Control group (N = 45) : routine care
* Interventionnal group (N=45) : routine care + use of connected scale All participants will undergo physical activity rehabilitation program during 6 weeks.
Patients will be see again at 6 months, and the following parameters will be comparer between the two groups :
* SF-36 questionnaire
* Ricci \& Gagnon questionnaire
* 6MWT
* 30 sec sit-to stand test
* Ito-Shirado test
* Sorensen test
* Handgrip test
* MaxV02
Who can participate
Age range
18 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 (male or female) aged 18 and over
* Patient able to express free, informed and written consent
* Patient participating in the physical activity rehabilitation program at the CIMS of the Hôtel Dieu
* Patient suffering from a known, stable and diagnosed chronic disease
* Patient autonomous in taking treatments for their ALD
* Patient affiliated to a social security system
Exclusion Criteria:
* Patient under legal protection (guardianship, curatorship)
* Patient deprived of liberty by a judicial or administrative decision
* Patient with functional limitations that do not allow a physical assessment or result in a walking distance \< 350 m during the HDJ for admission to the program
* Patient with suspected cardiac pathology during the HDJ for admission to the program
* Patient with episode of decompensation or exacerbation
* Patient with a pacemaker or implantable automatic defibrillator
* Pregnant women
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Measurement of the physical and mental quality of life score using the Short Form 36 questionnaire at 6 months for each patient.
Timeframe: 6 months from initiation of physical activity rehabilitation program