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

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ClinicalTrials.gov Identifier: NCT02307942
Recruitment Status : Recruiting
First Posted : December 4, 2014
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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).

Condition or disease Intervention/treatment Phase
Obesity Procedure: Gastric banding Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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



Primary Outcome Measures :
  1. Physical performance [ Time Frame: 12 months, comparing to the 6 months assesment ]
    Short Physical Performance Battery score (SPPB)


Secondary Outcome Measures :
  1. Physical performance [ Time Frame: At randomization, 6 and 12 months later ]
    the components of the SPPB score

  2. weight loss [ Time Frame: At randomization, 6 and 12 months later ]
    kg, and % of initial weight

  3. 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

  4. Changes in muscle strength [ Time Frame: At randomization, 6 and 12 months later ]
    strain gauge

  5. Changes in aerobic fitness [ Time Frame: At randomization, 6 and 12 months later ]
    maximal aerobic capacity

  6. 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

  7. Calorie and protein intake [ Time Frame: At randomization, 6 and 12 months later ]
    dietary survey

  8. Quality of life [ Time Frame: At randomization, 6 and 12 months later ]
    Nottingham quality of life score

  9. Disability [ Time Frame: At randomization, 6 and 12 months later ]
    Functional Status Questionnaire score

  10. Cognitive function [ Time Frame: At randomization, 6 and 12 months later ]
    MMSE



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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307942


Contacts
Contact: Patrick RITZ, MD; PHD 33 567771638 ritz.p@chu-toulouse.fr
Contact: Emmanuelle LAMI, MSc 33 561323361 lami.e@chu-toulouse.fr

Locations
France
Clinique de l'ANJOU Not yet recruiting
Angers, France, 49000
Contact: Philippe TOPART, MD    33 2 41 48 54 99      
Principal Investigator: Philippe TOPART, MD         
Sub-Investigator: Guillaume BECOUARN, MD         
Sub-Investigator: Franck HAMARD, MD         
Sub-Investigator: Agnès SALLE, MD         
Hôpital louis Mourier Not yet recruiting
Colombes, France, 92701
Contact: Simon MSIKA, MD; PHD    33 1 47 60 63 81    simon.msika@lmr.aphp.fr   
Principal Investigator: Simon MSIKA, MD; PHD         
Sub-Investigator: Hawa KEITA-MEYER, MD; PHD         
Sub-Investigator: Muriel COUPAYE, MD         
CHU de LILLE Not yet recruiting
Lille, France, 59000
Contact: François PATTOU, MD; PhD    33 3 20 44 42 73    fpattou@univ-lille2.fr   
Principal Investigator: François PATTOU, MD; PhD         
Sub-Investigator: Robert CAIAZZO, MD         
Sub-Investigator: Hélène VERKINDT, MD         
Sub-Investigator: Maire PIGEYRE, MD         
Sub-Investigator: Gilles LEBUFFE, MD; PhD         
Hospices Civils de LYON Not yet recruiting
Lyon, France, 69495
Contact: Martine LAVILLE, MD; PhD    33426235917    martine.laville@univ-lyon1.fr   
Principal Investigator: Martine LAVILLE, MD; PhD         
Sub-Investigator: Emmanuel DISSE, MD; PhD         
Sub-Investigator: Chantal SIMON, MD; PhD         
Sub-Investigator: Maud ROBERT, MD         
Sub-Investigator: Mary-Charlotte LE GOFF, MD         
CHU de Nantes Not yet recruiting
Nantes, France, 44093
Contact: Michel KREMPF, MD; PhD    33 2 53 48 27 01    michel.krempf@univ-nantes.fr   
Principal Investigator: Michel KREMPF, MD; PhD         
Sub-Investigator: Eric LETESSIER, MD         
Sub-Investigator: Jean-Pierre FRABOUL, MD         
HEGP Not yet recruiting
Paris, France, 75015
Contact: Jean-Marc CHEVALLIER, MD; PHD    33 1 56 09 35 37    jean-marc.chevallier@egp.aphp.fr   
Principal Investigator: Jean-Marc CHEVALLIER, MD; PHD         
Sub-Investigator: Jean-Jacques ALTMAN, MD; PHD         
Sub-Investigator: Denis SAFRAN, MD         
CHU de Toulouse Recruiting
Toulouse, France, 31059
Contact: Patrick RITZ, MD; PhD       ritz.p@chu-toulouse.fr   
Sub-Investigator: Yves ROLLAND, MD; PhD         
Principal Investigator: Patrick Ritz, MD; PhD         
Sub-Investigator: Bruno VELLAS, MD; PHD         
Sub-Investigator: Gilles FOURTANIER, MD; PhD         
Sub-Investigator: Mael Chalret du Rieu, MD         
Sub-Investigator: Olivier FOURCADE, MD; PhD         
Sub-Investigator: Danièle RIVIERE, MD; PhD         
Sub-Investigator: Fabien PILLARD, MD         
Sub-Investigator: Ana ESTRADE, MD         
Sub-Investigator: Charlotte VAURS, MD         
Sub-Investigator: Anne GHISOLFI, MD         
Sub-Investigator: Hélène HANAIRE, MD; PhD         
Sub-Investigator: Gisèle HERNANDEZ, MD; PhD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Patrick RITZ, MD; PhD University Hospital of Toulouse, France

Publications:
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02307942     History of Changes
Other Study ID Numbers: 13 7051 01
13705101 ( Other Grant/Funding Number: PHRC National 2013 )
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Toulouse:
Randomized Clinical Trials
gastric banding
calorie restriction
SPPB
physical performance
elderly

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms