Excess Skin and Physical Activity

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Marie-France Langlois, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01527851
First received: February 1, 2012
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Impact of Excess Skin on the Practice of Physical Activity in Women Who Underwent Bariatric Surgery and Exploration of the Benefits of Plastic Surgery

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Physical activity pratice [ Time Frame: Initial ] [ Designated as safety issue: Yes ]
    Inconvenience during physical activity


Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A group of 20 people who underwent bariatric surgery and a group of 10 people who underwent bariatric surgery and one or several plastic surgery

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527851

Locations
Canada, Quebec
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Sponsors and Collaborators
Université de Sherbrooke
  More Information

No publications provided by Université de Sherbrooke

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marie-France Langlois, Principal investigator, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01527851     History of Changes
Other Study ID Numbers: 11-190
Study First Received: February 1, 2012
Last Updated: March 3, 2014
Health Authority: Canada: Health Canada

Keywords provided by Université de Sherbrooke:
Post-bariatric surgery
Excess skin
Physical fitness
Physical activity
Barriers to physical activity
Plastic surgery
Quality of life
Self-esteem

ClinicalTrials.gov processed this record on October 01, 2014