Improvement in Physical Performance and Obesity Surgery in Patients Older Than 60 Years (NCT02307942) | Clinical Trial Compass
CompletedNot Applicable
Improvement in Physical Performance and Obesity Surgery in Patients Older Than 60 Years
France32 participantsStarted 2015-07-29
Plain-language summary
The main objective of this study is to compare the efficacy of two weight losing strategies (obesity surgery with gastric banding, and standard of care) on physical performance in elderly obese persons submitted to a physical training. Our hypothesis is that a surgery-induced weight loss in the context of a physical training (which is recommended in people 60-75 yrs losing weight) improves physical performance as compared to standard of care (3-5% weight loss).
Who can participate
Age range60 Years – 75 Years
SexALL
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Inclusion Criteria:
Criteria specific to the study Subjects aged 60 or over and younger than 75 yrs., seeking obesity treatments, seeking obesity surgery, with a BMI of 30 kg/m² or more, with comorbidities (see below), and a mildly decreased physical performance (SPPB between 5 and 8) are considered to participate in the study Criteria specific to obesity surgery This projects extends the classical recommendation for obesity surgery to people with a BMI of 30 and over with either the comorbidities list below, or a SPPB between 5 and 8. This level of physical impairment can be considered as a comorbidity in the elderly.
The French Ministry of health (HAS) recommends that obesity surgery be considered (here with a gastric banding) in patients fulfilling the following criteria:
* Subjects with a BMI of 40kg/m² or more, or 35kg/m² or more if at least one comorbidity that can be improved by weight loss is present among hypertension, obstructive sleep apnea, severe metabolic disorder (such as type 2 diabetes, NASH), or rheumatologic conditions associated with disability.
* After the failure of well designed medical, dietetic, psychological intervention followed up for 6-12 months, with no sufficient weight loss or in case of the failure of maintaining weight loss
* In subjects well informed of the consequences of surgery, and after a multi-disciplinary evaluation
* Subjects have understood and accepted the need for a long term medical and surgical follow up
* The risk of surgery…
What they're measuring
1
Physical performance
Timeframe: 12 months, comparing to the 6 months assesment