Effectiveness of Individualized Exercise Program, Combined With a Balanced Diet on the Evolution … (NCT01464073) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of Individualized Exercise Program, Combined With a Balanced Diet on the Evolution of Body Fat
France137 participantsStarted 2011-11
Plain-language summary
The purpose of this study is to evaluate the efficacy of 3 of physical exercise training programs, with a supplementation in fruits and vegetables, on body composition. 126 women will be randomized into 3 groups (42 subjects per group). The first program will be conducted at a relatively low intensity of effort, corresponding to the maximum rate of lipid oxidation (LIPOXmax)measured by indirect calorimetry. The second program will be at 60% of VO2peak and the third program will be prescribed according to the Good Practices physical Guidelines (30 minutes per day at a moderate intensity). All subjects will receive a free supplement of 5 fruits and vegetables per day during all the intervention. The intervention will last 5 months in total.
Who can participate
Age range
20 Years – 40 Years
Sex
FEMALE
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:
* women
* 20-40 years old
* 27 ≤ BMI ≤40 kg / m²
* sedentary
* considered clinically stable
* able to rehabilitation training
* having signed an informed consent
* without professional activity
Exclusion Criteria:
* blood glucose ≥ 1.26 g / l
* HbA1c ≥ 6.5%
* severe hypertension (SBP ≥ 180 mmHg and / or DBP ≥ 110 mmHg)
* hypertension (≥140/90 mmHg) untreated or treated by beta blocker or calcium blocker
* absolute and relative contraindication to the maximal exercise test (ACC / AHA 2002) and / or physical training
* inability to achieve the maximum exercise test and / or the metabolic exercise test by indirect calorimeter
* uncompensated cardiovascular and / or respiratory disease revealed by exercise test
* pacemaker or defibrillator
* recent cardiovascular events (heart failure, treated by positive inotropic drugs, angioplasty within the last 10 days, cardiac surgery within the last 3 months, valvular disease requiring surgical correction, evolving myopericarditis, severe ventricular arrhythmias non stabilized under treatment)
* known and documented myopathy
* cancer
* acute and chronic inflammatory disease
* end stage renal disease
* digestive system operation
* treated by corticoids, thyroid hormone, antidepressant or neuroleptics
* pregnancy
* mental deficiency that prevents the understanding of informed consent and protocol
* participation to another research protocol
* attendance in the previous month to a program of rehabilitation training or a…
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
body fat mass reduction
Timeframe: change from baseline in body fat mass at 5 months
Trial details
NCT IDNCT01464073
SponsorCentre Hospitalier Universitaire de la Réunion