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

Primary Purpose

Obesity

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Gastric banding

About this trial

This is an interventional treatment trial for Obesity focused on measuring Randomized Clinical Trials, gastric banding, calorie restriction, SPPB, physical performance, elderly

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hôpital louis Mourier
CHU de LILLE
Hospices Civils de LYON
CHU de Nantes
HEGP
CHU de Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SURGERY

STANDARD

Arm Description

Patient will be operated for a gastric banding disposal

Standard of care for obesity

Outcomes

Primary Outcome Measures

Physical performance

Short Physical Performance Battery score (SPPB)

Secondary Outcome Measures

Physical performance

the components of the SPPB score

weight loss

kg, and % of initial weight

Composition of weight loss

% of weight lost as lean mass, as fat mass, changes in appendicular skeletal muscle mass

Changes in muscle strength

strain gauge

Changes in aerobic fitness

maximal aerobic capacity

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

Calorie and protein intake

dietary survey

Quality of life score

Nottingham quality of life score

Disability

Functional Status Questionnaire score

Cognitive function

MMSE

Full Information

NCT ID

NCT02307942

First Posted

September 16, 2014

Last Updated

October 27, 2021

Sponsor

University Hospital, Toulouse

1. Study Identification

Unique Protocol Identification Number

NCT02307942

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

July 29, 2015 (Actual)

Primary Completion Date

December 4, 2019 (Actual)

Study Completion Date

December 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SURGERY

Arm Type

Experimental

Arm Description

Patient will be operated for a gastric banding disposal

Arm Title

STANDARD

Arm Type

No Intervention

Arm Description

Standard of care for obesity

Intervention Type

Procedure

Intervention Name(s)

Gastric banding

Intervention Description

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.

Primary Outcome Measure Information:

Title

Physical performance

Description

Short Physical Performance Battery score (SPPB)

Time Frame

12 months, comparing to the 6 months assesment

Secondary Outcome Measure Information:

Title

Physical performance

Description

the components of the SPPB score

Time Frame