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| ID | Type | Description | Link |
|---|---|---|---|
| 13705101 | Other Grant/Funding Number | PHRC National 2013 |
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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).
Randomized clinical trial; Single Blind A physical training is recommended in people above 60 yrs. engaged in a weight-losing program, in order to prevent the impairment of physical performance. Therefore a physical training program (endurance and strength training) will be implemented for all subjects participating in the study, starting 1 month before randomization. It will last for 13 months. Patients will be randomized either in the surgical group (gastric banding under general anesthesia) or in the reference group (mild calorie restriction and coaching). Physical performance of patients is evaluated at screening, inclusion, at randomization, 6 and 12 months after randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SURGERY | Experimental | Patient will be operated for a gastric banding disposal |
|
| STANDARD | No Intervention | Standard of care for obesity |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric banding | Procedure | The bariatric procedure is a gastric banding under general anesthesia with all the centres using the same surgical procedure (harmonized by group meetings). The laparoscopic surgical procedure has been described. The ERAS protocol will be applied in each centre. The inflation of the band will follow the procedures described by 0'Brien. The patients will attend a group education session before surgery, during which the eating behaviour with a band will be explained and practiced. Then after surgery, the routine procedure is applied. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical performance | Short Physical Performance Battery score (SPPB) | 12 months, comparing to the 6 months assesment |
| Measure | Description | Time Frame |
|---|---|---|
| Physical performance | the components of the SPPB score | At randomization, 6 and 12 months later |
| weight loss | kg, and % of initial weight |
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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:
Exclusion Criteria:
Criteria specific to the study
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| Name | Affiliation | Role |
|---|---|---|
| Patrick RITZ, MD; PhD | University Hospital of Toulouse, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de l'ANJOU | Angers | 49000 | France | |||
| Hôpital louis Mourier |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15479938 | Background | Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724. | |
| 15072664 | Background | Chevallier JM, Zinzindohoue F, Douard R, Blanche JP, Berta JL, Altman JJ, Cugnenc PH. Complications after laparoscopic adjustable gastric banding for morbid obesity: experience with 1,000 patients over 7 years. Obes Surg. 2004 Mar;14(3):407-14. doi: 10.1381/096089204322917954. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| At randomization, 6 and 12 months later |
| Composition of weight loss | % of weight lost as lean mass, as fat mass, changes in appendicular skeletal muscle mass | At randomization, 6 and 12 months later |
| Changes in muscle strength | strain gauge | At randomization, 6 and 12 months later |
| Changes in aerobic fitness | maximal aerobic capacity | At randomization, 6 and 12 months later |
| Early complications | in operated patients : number of hospital re-admissions, number of deep venous thrombosis, number of pulmonary embolism, food intake (calories, protein, eating difficulties | At randomization, 6 and 12 months later |
| Calorie and protein intake | dietary survey | At randomization, 6 and 12 months later |
| Quality of life score | Nottingham quality of life score | At randomization, 6 and 12 months later |
| Disability | Functional Status Questionnaire score | At randomization, 6 and 12 months later |
| Cognitive function | MMSE | At randomization, 6 and 12 months later |
| Colombes |
| 92701 |
| France |
| CHU de LILLE | Lille | 59000 | France |
| Hospices Civils de LYON | Lyon | 69495 | France |
| CHU de Nantes | Nantes | 44093 | France |
| HEGP | Paris | 75015 | France |
| CHU de Toulouse | Toulouse | 31059 | France |
| 23235396 | Background | O'Brien PE, MacDonald L, Anderson M, Brennan L, Brown WA. Long-term outcomes after bariatric surgery: fifteen-year follow-up of adjustable gastric banding and a systematic review of the bariatric surgical literature. Ann Surg. 2013 Jan;257(1):87-94. doi: 10.1097/SLA.0b013e31827b6c02. |
| 19763708 | Background | Mittermair RP, Obermuller S, Perathoner A, Sieb M, Aigner F, Margreiter R. Results and complications after Swedish adjustable gastric banding-10 years experience. Obes Surg. 2009 Dec;19(12):1636-41. doi: 10.1007/s11695-009-9967-7. |
| 18043107 | Background | Chevallier JM, Paita M, Rodde-Dunet MH, Marty M, Nogues F, Slim K, Basdevant A. Predictive factors of outcome after gastric banding: a nationwide survey on the role of center activity and patients' behavior. Ann Surg. 2007 Dec;246(6):1034-9. doi: 10.1097/SLA.0b013e31813e8a56. |
| 18387472 | Background | Gagner M, Milone L, Yung E, Broseus A, Gumbs AA. Causes of early mortality after laparoscopic adjustable gastric banding. J Am Coll Surg. 2008 Apr;206(4):664-9. doi: 10.1016/j.jamcollsurg.2007.11.014. Epub 2008 Jan 28. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |