Improvement in Physical Performance and Obesity Surgery in Patients Older Than 60 Years

Obesity Clinical Trial

— ELDSURG  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307942
• Other study ID #: 13 7051 01
• Secondary ID: 13705101
• Status: Completed
• Phase: N/A
• Start date: July 29, 2015
• Est. completion date: December 4, 2019

Study information

• Verified date: October 2021
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 4, 2019
• Est. primary completion date: December 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Gastric banding
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.

Locations

Country	Name	City	State
France	Hôpital louis Mourier	Colombes
France	CHU de LILLE	Lille
France	Hospices Civils de LYON	Lyon
France	CHU de Nantes	Nantes
France	HEGP	Paris
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (6)

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. Review. Erratum in: JAMA. 2005 Apr 13;293(14):1728. — View 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. — View Citation

Chevallier JM, Zinzindohoué 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. — View 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. Review. — View Citation

Mittermair RP, Obermüller 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical performance	Short Physical Performance Battery score (SPPB)	12 months, comparing to the 6 months assesment
Secondary	Physical performance	the components of the SPPB score	At randomization, 6 and 12 months later
Secondary	weight loss	kg, and % of initial weight	At randomization, 6 and 12 months later
Secondary	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
Secondary	Changes in muscle strength	strain gauge	At randomization, 6 and 12 months later
Secondary	Changes in aerobic fitness	maximal aerobic capacity	At randomization, 6 and 12 months later
Secondary	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
Secondary	Calorie and protein intake	dietary survey	At randomization, 6 and 12 months later
Secondary	Quality of life score	Nottingham quality of life score	At randomization, 6 and 12 months later
Secondary	Disability	Functional Status Questionnaire score	At randomization, 6 and 12 months later
Secondary	Cognitive function	MMSE	At randomization, 6 and 12 months later