Physical Activity and Bariatric Surgery

NCT05050968 | Completed

• 1 other identifier: CHRO-2016-03
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Bariatric surgery indeed leads to significant weight loss, reduces mortality risk, obesity-associated comorbidities (Wolfe et al., 2016) and improves functional physical abilities (Herring et al., 2016). Because these benefits are related to decreased energy intake, the investigators aim to optimize them by combining them with supervised adapted physical activity practice. So, the aim of this clinical trial is to measure the effects of a physical training program on physical fitness, body composition and quality of life of obese women who have undergone bariatric surgery.

Conditions

Bariatric Surgery Candidate

Keywords

Physical activity; Bariatric Surgery; Physical Fitness; Quality of life; Body Composition

Outcome Measures

Primary Outcomes (3)

• Maximum oxygen consumption (VO2 max)

  The VO2 max is measured during an effort test with progressively increasing and maximum load which consists in making the subject pedal against an increasing load

  Week 6

• Maximum oxygen consumption (VO2 max)

  The VO2 max is measured during an effort test with progressively increasing and maximum load which consists in making the subject pedal against an increasing load

  Week 18

• Maximum oxygen consumption (VO2 max)

  The VO2 max is measured during an effort test with progressively increasing and maximum load which consists in making the subject pedal against an increasing load

  Week 30

Secondary Outcomes (30)

• Impact of obesity on the physical, psycho-social, dietary well-being and dieting experience assessed using the Quality of Life, Obesity and Diet Scale (QOLDS)

  Week 6

• Impact of obesity on the physical, psycho-social, dietary well-being and dieting experience assessed using the Quality of Life, Obesity and Diet Scale (QOLDS)

  Week 18

• Impact of obesity on the physical, psycho-social, dietary well-being and dieting experience assessed using the Quality of Life, Obesity and Diet Scale (QOLDS)

  Week 30

• Walking distance

  Week 6

• Walking distance

  Week 18

Study Arms (2)

Adapted Physical Activity Group

EXPERIMENTAL

Patients will follow a 3-month physical activity program 3 times a week between V1 and V2. Then, between V2 and V3, no APA program will be offered to both groups.

Other: Physical activity

Control group

NO INTERVENTION

Patients will receive standard hospital management

Interventions

Physical activity OTHER

Between V1 and V2 (i.e. 12 weeks), the APAG (Adapted Physical Activity Group) will participate at a physical training program, 3 sessions of 1h30 per week consisting of endurance activities (60-75% of VO2 peak) and muscle strengthening while the CG will not perform any controlled physical training program. Then, between V2 and V3, no APA (Adapted Physical Activity) program will be offered to both groups.

Adapted Physical Activity Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women between 18 and 55 years old
• undergoing bariatric surgery (a "bypass gastric" or a "sleeve")
• not practicing a supervised physical activity
• having read and signed an informed consent prior to the start of the trial
• being affiliated to a social security system

You may not qualify if:

• Women with a contraindication to physical activity
• any medical contraindication to the practice of stress tests.
• unable to go to the hospital regularly
• having a significant functional limitation that does not allow her to perform the 6-minute walk test
• with an intellectual disability and/or psychiatric illness
• does not speak and/or understand French
• pregnant woman
• under guardianship or curatorship
• participating in another clinical research

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHR Orléans

Orléans, 45067, France

Location

Related Publications (7)

• Baillot A, Audet M, Baillargeon JP, Dionne IJ, Valiquette L, Rosa-Fortin MM, Abou Chakra CN, Comeau E, Langlois MF. Impact of physical activity and fitness in class II and III obese individuals: a systematic review. Obes Rev. 2014 Sep;15(9):721-39. doi: 10.1111/obr.12171. Epub 2014 Apr 9.

  PMID: 24712685 BACKGROUND

• Berggren JR, Boyle KE, Chapman WH, Houmard JA. Skeletal muscle lipid oxidation and obesity: influence of weight loss and exercise. Am J Physiol Endocrinol Metab. 2008 Apr;294(4):E726-32. doi: 10.1152/ajpendo.00354.2007. Epub 2008 Feb 5.

  PMID: 18252891 BACKGROUND

• Blair SN, Cheng Y, Holder JS. Is physical activity or physical fitness more important in defining health benefits? Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S379-99; discussion S419-20. doi: 10.1097/00005768-200106001-00007.

  PMID: 11427763 BACKGROUND

• Bond DS, Phelan S, Wolfe LG, Evans RK, Meador JG, Kellum JM, Maher JW, Wing RR. Becoming physically active after bariatric surgery is associated with improved weight loss and health-related quality of life. Obesity (Silver Spring). 2009 Jan;17(1):78-83. doi: 10.1038/oby.2008.501. Epub 2008 Nov 6.

  PMID: 18997679 BACKGROUND

• Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep. 1985 Mar-Apr;100(2):126-31.

  PMID: 3920711 BACKGROUND

• Wolfe BM, Kvach E, Eckel RH. Treatment of Obesity: Weight Loss and Bariatric Surgery. Circ Res. 2016 May 27;118(11):1844-55. doi: 10.1161/CIRCRESAHA.116.307591.

  PMID: 27230645 BACKGROUND

• Herring LY, Stevinson C, Davies MJ, Biddle SJ, Sutton C, Bowrey D, Carter P. Changes in physical activity behaviour and physical function after bariatric surgery: a systematic review and meta-analysis. Obes Rev. 2016 Mar;17(3):250-61. doi: 10.1111/obr.12361. Epub 2016 Jan 18.

  PMID: 26783103 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Virgile AMIOT, Dr

  CHR d'Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is an open-label, randomized, single-center trial with two groups: an Adapted Physical Activity group and a control group performing no controlled physical activity within each group women undergoing bypass or sleeve surgery

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: September 21, 2021
• Study Start: February 23, 2018
• Primary Completion: June 7, 2021
• Study Completion: June 7, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

FR (1)