Clinical trial NCT02307942: Improvement in Physical Performance and Obesity Surgery in Patients Older Than 60 Years
Official title: Does Intense Weight Loss Improve Physical Performance in Obese Patients Older Than 60 Yrs Undergoing Exercise Training? Comparison Between Surgery and Standard of Care.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Randomized Clinical Trials
gastric banding
calorie restriction
SPPB
physical performance
elderly
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 32
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility criteria: 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 is acceptable
* patient who signed the informed consent
* patient affiliated to a social security cover or equivalent

Exclusion Criteria:

Criteria specific to the study

* These are the impossibility to follow a physical training (unstable coronary heart disease, severe lung function impairment, rheumatologic conditions preventing training, a SPPB score below 5, cancer treatment within the 3 last months, Parkinson's disease, other severe illness that may interfere with physical activity) Criteria specific to gastric banding
* Cognitive impairment (MMSE ≤ 25)
* Severe eating disorder
* Impossible long-term follow-up
* Alcohol or drug dependence
* Lack of previous well designed obesity care
* Vital prognosis engaged in the short term
* Contra-indications to anaesthesia Classical criteria for the non inclusion in a trial
* The subject is in jail, or has freedom restriction
* Guardianship curators or judicial protection
* Patients participating in another intervention study.

Primary outcomes:
measure: Physical performance
timeFrame: 12 months, comparing to the 6 months assesment
Secondary outcomes:
measure: Physical performance
timeFrame: At randomization, 6 and 12 months later
measure: weight loss
timeFrame: At randomization, 6 and 12 months later
measure: Composition of weight loss
timeFrame: At randomization, 6 and 12 months later
measure: Changes in muscle strength
timeFrame: At randomization, 6 and 12 months later
measure: Changes in aerobic fitness
timeFrame: At randomization, 6 and 12 months later
measure: Early complications
timeFrame: At randomization, 6 and 12 months later
measure: Calorie and protein intake
timeFrame: At randomization, 6 and 12 months later
measure: Quality of life score
timeFrame: At randomization, 6 and 12 months later
measure: Disability
timeFrame: At randomization, 6 and 12 months later
measure: Cognitive function
timeFrame: At randomization, 6 and 12 months later
Other outcomes:
Locations:
city: Angers
country: France
facility: Clinique de l'ANJOU
city: Colombes
country: France
facility: Hôpital louis Mourier
city: Lille
country: France
facility: CHU de LILLE
city: Lyon
country: France
facility: Hospices Civils de LYON
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: HEGP
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital of Toulouse, France
name: Patrick RITZ, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.