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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01527851
Other study ID # 11-190
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2012
Est. completion date January 11, 2021

Study information

Verified date January 2021
Source Université de Sherbrooke
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Introduction: Currently, bariatric surgery appears to be the most effective treatment to improve the health of morbidly obese population. However, the massive weight loss induced by this intervention can create excess loose skin in various parts of the body contributing to the feeling of failure in their desire to feel better in some patients. Several studies show that people are once again disappointed and dissatisfied with their body appearance due to the mass of unsightly loose skin that disrupts their quality of life. However, very few studies have focused on the barriers that this excess skin could create in everyday physical activity. The aim of the investigators pilot study is to assess the impact of excess skin on the practice of physical activity in women who underwent bariatric surgery and evaluate if there is a relationship between physical activity and the level and location of excess skin. Also, the investigators will explore, the benefits of plastic surgery in patients who had this intervention. Materials and methods: About twenty women who underwent bariatric surgery and a dozen who had subsequent plastic surgery will be included in this pilot study. Anthropometry, weight loss post bariatric and plastic surgery, motivational stage on the practice of physical activity, usual practice of physical activity, functional and physical ability, perceived benefits and barriers of physical activity, self-esteem and quality of life will be assessed. After analyzing the results, a group discussion will be established to further evaluate the impact of excess skin on the practice of physical activity. The evaluation will be identical for monitoring the effects of plastic surgery but the discussion group will also address the benefits and satisfaction related to plastic surgery. Expected results: Excess skin could be a barrier to physical activity by limiting the functional and physical capacity. Thus, plastic surgery could improve the practice of physical activity with a direct improvement of functional discomfort, the subjects' motivation to be physically active, perceived benefits and barriers to physical activity, self-esteem and quality of life. Issue project: This pilot project will generate data that will allow us, depending on the relevance of the results, to continue the investigators investigation with a larger cohort.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date January 11, 2021
Est. primary completion date October 21, 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - have underwent bariatric surgery more than 1 year ago - had a weight loss of at least 20% after bariatric surgery - had a weight change of less than 5 kg in the last 3 months - woman > 18 years old - have read and given consent Inclusion Criteria for the group post-plastic: - have underwent a plastic surgery at least 6 months ago Exclusion Criteria: - medical contraindication for physical activity - major functional limitations : failure to realize different tests - intellectual disability and/or neuropsychological disease - not being able to speak or understand french

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Centre hospitalier universitaire de Sherbrooke Sherbrooke Quebec

Sponsors (1)

Lead Sponsor Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical activity pratice Inconvenience during physical activity Initial
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