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

NCT02307942 | Completed DMC

• 2 other identifiers: 13 7051 0113705101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 7

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).

Conditions

Obesity

Keywords

Randomized Clinical Trials; gastric banding; calorie restriction; SPPB; physical performance; elderly

Outcome Measures

Primary Outcomes (1)

• Physical performance

  Short Physical Performance Battery score (SPPB)

  12 months, comparing to the 6 months assesment

Secondary Outcomes (10)

• Physical performance

  At randomization, 6 and 12 months later

• weight loss

  At randomization, 6 and 12 months later

• Composition of weight loss

  At randomization, 6 and 12 months later

• Changes in muscle strength

  At randomization, 6 and 12 months later

• Changes in aerobic fitness

  At randomization, 6 and 12 months later

Study Arms (2)

SURGERY

EXPERIMENTAL

Patient will be operated for a gastric banding disposal

Procedure: Gastric banding

STANDARD

NO INTERVENTION

Standard of care for obesity

Interventions

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.

SURGERY

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• The subject is in jail, or has freedom restriction
• Guardianship curators or judicial protection
• Patients participating in another intervention study.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (7)

Clinique de l'ANJOU

Angers, 49000, France

Location

Hôpital louis Mourier

Colombes, 92701, France

Location

CHU de LILLE

Lille, 59000, France

Location

Hospices Civils de LYON

Lyon, 69495, France

Location

CHU de Nantes

Nantes, 44093, France

Location

HEGP

Paris, 75015, France

Location

CHU de Toulouse

Toulouse, 31059, France

Location

Related 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. doi: 10.1001/jama.292.14.1724.

  PMID: 15479938 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.

  PMID: 15072664 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.

  PMID: 23235396 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.

  PMID: 19763708 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.

  PMID: 18043107 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.

  PMID: 18387472 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick RITZ, MD; PhD

  University Hospital of Toulouse, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: December 4, 2014
• Study Start: July 29, 2015
• Primary Completion: December 4, 2019
• Study Completion: December 4, 2019
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)