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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
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.
Clinique de l'ANJOU
Angers, France
Hôpital louis Mourier
Colombes, France
CHU de LILLE
Lille, France
Hospices Civils de LYON
Lyon, France
Physical performance
Short Physical Performance Battery score (SPPB)
Time frame: 12 months, comparing to the 6 months assesment
Physical performance
the components of the SPPB score
Time frame: At randomization, 6 and 12 months later
weight loss
kg, and % of initial weight
Time frame: 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
Time frame: At randomization, 6 and 12 months later
Changes in muscle strength
strain gauge
Time frame: At randomization, 6 and 12 months later
Changes in aerobic fitness
maximal aerobic capacity
Time frame: 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
Time frame: At randomization, 6 and 12 months later
Calorie and protein intake
dietary survey
Time frame: At randomization, 6 and 12 months later
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CHU de Nantes
Nantes, France
HEGP
Paris, France
CHU de Toulouse
Toulouse, France
Quality of life score
Nottingham quality of life score
Time frame: At randomization, 6 and 12 months later
Disability
Functional Status Questionnaire score
Time frame: At randomization, 6 and 12 months later
Cognitive function
MMSE
Time frame: At randomization, 6 and 12 months later