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

August 27, 2024 updated by: University Hospital, Toulouse

Does Intense Weight Loss Improve Physical Performance in Obese Patients Older Than 60 Yrs Undergoing Exercise Training? Comparison Between Surgery and Standard of Care.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • Clinique de l'Anjou
      • Colombes, France, 92701
        • Hôpital Louis Mourier
      • Lille, France, 59000
        • CHU de Lille
      • Lyon, France, 69495
        • Hospices Civils de Lyon
      • Nantes, France, 44093
        • CHU de Nantes
      • Paris, France, 75015
        • HEGP
      • Toulouse, France, 31059
        • CHU de Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SURGERY
Patient will be operated for a gastric banding disposal
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.
No Intervention: STANDARD
Standard of care for obesity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical performance
Time Frame: 12 months, comparing to the 6 months assesment
Short Physical Performance Battery score (SPPB)
12 months, comparing to the 6 months assesment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical performance
Time Frame: At randomization, 6 and 12 months later
the components of the SPPB score
At randomization, 6 and 12 months later
weight loss
Time Frame: At randomization, 6 and 12 months later
kg, and % of initial weight
At randomization, 6 and 12 months later
Composition of weight loss
Time Frame: At randomization, 6 and 12 months later
% of weight lost as lean mass, as fat mass, changes in appendicular skeletal muscle mass
At randomization, 6 and 12 months later
Changes in muscle strength
Time Frame: At randomization, 6 and 12 months later
strain gauge
At randomization, 6 and 12 months later
Changes in aerobic fitness
Time Frame: At randomization, 6 and 12 months later
maximal aerobic capacity
At randomization, 6 and 12 months later
Early complications
Time Frame: At randomization, 6 and 12 months later
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
Calorie and protein intake
Time Frame: At randomization, 6 and 12 months later
dietary survey
At randomization, 6 and 12 months later
Quality of life score
Time Frame: At randomization, 6 and 12 months later
Nottingham quality of life score
At randomization, 6 and 12 months later
Disability
Time Frame: At randomization, 6 and 12 months later
Functional Status Questionnaire score
At randomization, 6 and 12 months later
Cognitive function
Time Frame: At randomization, 6 and 12 months later
MMSE
At randomization, 6 and 12 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Patrick RITZ, MD; PhD, University Hospital of Toulouse, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2015

Primary Completion (Actual)

December 4, 2019

Study Completion (Actual)

December 4, 2019

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimated)

December 4, 2014

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13 7051 01
  • 13705101 (Other Grant/Funding Number: PHRC National 2013)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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