Clinical trial NCT05050968: Physical Activity and Bariatric Surgery
Official title: Effects of Controlled Physical Activity on the Fitness, Body Composition and Quality of Life of Obese Women Undergoing Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Keywords: Physical activity
Bariatric Surgery
Physical Fitness
Quality of life
Body Composition
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: PREVENTION

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.

Detailed description: Upon hospitalization for their bariatric surgery (bypass or sleeve), subjects will sign their informed consent and be included in the study. Six weeks' post-surgery, the subjects will be randomized in one of the 2 groups (Control group CG or Adapted Physical Activity group APAG). Patients in both groups will have 3 postoperative visits one at 6 weeks (V1), one at 18 weeks (V2) and one at 30 weeks (V3). During these visits, they will undergo the same assessments (body composition, physical condition, quality of life). Patients in the CG will receive standard hospital management. Patients in APAG will follow the same management and will also 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.

The subjects will evaluate during each visit V1, V2 and V3:

* body composition,
* physical condition,
* quality of life
* daily physical activity

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Maximum oxygen consumption (VO2 max)
timeFrame: Week 6
measure: Maximum oxygen consumption (VO2 max)
timeFrame: Week 18
measure: Maximum oxygen consumption (VO2 max)
timeFrame: Week 30
Secondary outcomes:
measure: 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)
timeFrame: Week 6
measure: 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)
timeFrame: Week 18
measure: 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)
timeFrame: Week 30
measure: Walking distance
timeFrame: Week 6
measure: Walking distance
timeFrame: Week 18
measure: Walking distance
timeFrame: Week 30
measure: Heart rate
timeFrame: Week 6
measure: Heart rate
timeFrame: Week 18
measure: Heart rate
timeFrame: Week 30
measure: Perception of the effort
timeFrame: Week 6
measure: Perception of the effort
timeFrame: Week 18
measure: Perception of the effort
timeFrame: Week 36
measure: Maximum voluntary force of the quadriceps
timeFrame: week 6
measure: Maximum voluntary force of the quadriceps
timeFrame: week 18
measure: Maximum voluntary force of the quadriceps
timeFrame: week 30
measure: grip strength
timeFrame: week 6
measure: grip strength
timeFrame: week 18
measure: grip strength
timeFrame: week 30
measure: Body composition
timeFrame: week 6
measure: Body composition
timeFrame: week 18
measure: Body composition
timeFrame: week 30
measure: Metabolic measurements
timeFrame: week 6
measure: Metabolic measurements
timeFrame: week 6
measure: Hormonal measurements
timeFrame: week 6
measure: Metabolic measurements
timeFrame: week 18
measure: Metabolic measurements
timeFrame: week 18
measure: Hormonal measurements
timeFrame: week 18
measure: Metabolic measurements
timeFrame: week 30
measure: Metabolic measurements
timeFrame: week 30
measure: Hormonal measurements
timeFrame: week 30
Other outcomes:
Locations:
city: Orleans 2
country: France
facility: CHR Orléans
Study officials:
affiliation: CHR d'Orléans
name: Virgile AMIOT, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.