Effects of Physical Training on Health Markers of Post-bariatric Patients (NCT04193397) | Clinical Trial Compass
CompletedNot Applicable
Effects of Physical Training on Health Markers of Post-bariatric Patients
Brazil100 participantsStarted 2022-12-01
Plain-language summary
The purpose of this clinical trial is to study the effects of resistance training program on physical-functional fitness, muscle mass and strength, endothelial function, blood pressure, biochemical markers of cardiovascular risk and bone metabolism, density and microstructure and quality of life of post-bariatric patients (Study 1). To compare the bone and muscle changes in post-bariatric patients by Roux-en-Y Gastric Bypass Surgery with non-bariatric controls, as well as to correlate these health indicators with surgery time and weight loss (Study 2).
Who can participate
Age range
18 Years – 50 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:
* Patients subjected to Roux-en-Y gastric bypass
* Aging 18 to 50-years
* At least 12 months from surgery
Exclusion criteria:
* Smoking
* Alcoholism
* Gestation
* Cardiovascular disease
* Respiratory disease
* Neurological disease
* Infectious disease
* Endocrine disease
* Musculoskeletal impairments
* Use of hormonal replacement therapy that influence bone metabolism
* Use of medications that influence bone metabolism
* Start some physical exercise program during the study
* Excess weight loss \<50%
* Use drugs that interfere with weight
* Revisional bariatric surgery
* Regular physical exercise
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
Changes from baseline body composition at 6 months
Timeframe: Baseline and 6 months of follow-up
2
Changes from baseline bone microarchitecture at 6 months
Timeframe: Baseline and 6 months of follow-up
3
Changes from baseline muscle strength at 6 months
Timeframe: Baseline and 6 months of follow-up
4
Changes from baseline blood biomarkers at 6 months
Timeframe: Baseline and 6 months of follow-up
5
Changes from baseline blood biomarkers at 6 months