Obesity Clinical Trial
— TelePreSETOfficial title:
Feasibility and Impacts of a Prebariatric Surgery Exercise Training in Telehealth: a Pilot Study
NCT number | NCT02083913 |
Other study ID # | 13-209 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2014 |
Est. completion date | September 2018 |
Verified date | October 2017 |
Source | Université de Sherbrooke |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of our study is to evaluate the feasibility of a supervised training session using telehealth in the "Clinique medico-chirurgicale du traitement de l'obésité de Sherbrooke" (CMCTO) and its impact on health, physical fitness, quality of life and satisfaction of subjects. 6 subjects awaiting bariatric surgery will be recruited. In addition to usual care, subjects will perform additional sessions of supervised endurance and resistance exercise training. Subjects will be instructed to perform two supervised exercise sessions per week with telehealth plus one without supervision during 12 weeks. The following outcomes will be assessed before and after the telePreSET, then 12 months after bariatric surgery: 1- physical fitness (6MWT, maximal strength, symptom-limited cardiac exercise test); 2-health related quality of life (Laval questionnaire); 3-weight, height, body composition (bioelectrical impedance scale); 4-comorbidities and metabolic parameters (files and blood samples); 5-exercise beliefs (Physical Exercise Belief questionnaire); 6-physical activity (GPAQuestionnaire and actimeter). The feasibility will be assessed with a satisfaction questionnaire concerning physical activity management, dropout and compliance rates, as well as the number of injuries and accidents. The results of this research will give us preliminary data for future projects in order to improve support of bariatric surgery candidates to assure optimal results for their health. Also, we will contribute to the advancement of scientific knowledge, absent in the current literature in this population.
Status | Completed |
Enrollment | 6 |
Est. completion date | September 2018 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - bariatric surgery candidate : morbid obesity (BMI>40)or severe obesity (BMI>35 with complications; > 18 years old) - follow usual care in the "Clinique médico-chirurgicale du traitement de l'obésité du Centre Hospitalier Universitaire de Sherbrooke (CHUS)" and ready to do pre-surgery evaluation (approximately 3 month before surgery) - no more than one supervised exercise training per week - inability to come regularly to the CHUS to participate in supervised exercise training - sufficient space to train at home (4m2) Exclusion Criteria: - medical contraindication for physical activity - major functional limitations: failure to realize the 6 minutes walking test - intellectual disability and / or neuropsychological disease - not being able to speak or understand french |
Country | Name | City | State |
---|---|---|---|
Canada | Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke |
Canada,
Baillot A, Mampuya WM, Comeau E, Méziat-Burdin A, Langlois MF. Feasibility and impacts of supervised exercise training in subjects with obesity awaiting bariatric surgery: a pilot study. Obes Surg. 2013 Jul;23(7):882-91. doi: 10.1007/s11695-013-0875-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in physical fitness | 6-minutes walking test distance (meter) treadmill symptom-limited cardiac exercise test (METs) | baseline, then 12 weeks after exercise training and one year after surgery | |
Secondary | Changes in quality of life scores | Laval questionnaire | baseline, then 12 weeks after exercise training and one year after surgery | |
Secondary | Changes in energy expenditure | Frequency of subjects reaching 150 min of moderate physical activity Total energy expenditure (kcal per day) Number of steps With accelerometer and international physical activity questionnaire | baseline, then 12 weeks after exercise training and one year after surgery | |
Secondary | Changes in weight (kg) | baseline, then 12 weeks after exercise training and one year after surgery | ||
Secondary | Changes in exercise beliefs | Exercise beliefs questionnaire: embarrassement, fear of injury, confidence, beliefs in physical activity benefits | baseline, then 12 weeks after exercise training and one year after surgery | |
Secondary | Final satisfaction | Heath care satisfaction questionnaire (% of subjects satisfied + mean score) TeleHeath care satisfaction questionnaire (% of subjects satisfied + mean score) | 12 weeks after exercise training | |
Secondary | Changes in body composition | % of fat mass and fat free mass (bioimpedancemeter) | aseline, then 12 weeks after exercise training and one year after surgery | |
Secondary | Changes in comorbidities | Medical charts: % of subjects with diabetes, hypertension, dyslipidemia, sleep apnea, depression, anxiety, arthrosis, osteoarthrosis | baseline, then 12 weeks after exercise training and one year after surgery | |
Secondary | Final compliance | Adherence of sessions Number of injuries or adverse events | 12 weeks after the beginning of the intervention |
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