University of British Columbia
Vancouver, British Columbia, V6T 1Z3, Canada
NCT Number: NCT04516473
Obesity is a growing chronic medical condition in which as of 2015, a total of 107.7 million children and 603.7 million adults were considered obese and since 1980 the prevalence of obesity has doubled in more than 70 countries. It is estimated that 70 percent of individuals who undergo a massive weight loss would develop excess skin and based on patient reported outcome measures, it has been shown that excess skin negatively impacts patients' body image, self-esteem, physical function and body contouring surgeries have been demonstrated to improve these measures. These are surgeries that correct for excess skin and its adverse consequences. The form of the surgery is case dependent and can range from removing an apron of skin to complete contouring of the abdomen with tightening of the abdominal muscle and moving the belly button. Despite previous studies indicating mobility limitation because of excess skin and improvements after abdominal body contouring surgeries with the use of subjective measures of physical function, there are no studies that directly measures physical fitness post body contouring surgeries. Therefore, the purpose of the current study is to evaluate the impact of abdominal body contouring surgeries on direct objective measures of physical function.
It is hypothesized that 1) the removal of excess skin will improve direct objective measures of physical function in post massive weight loss participants 2) the removal of excess skin will improve direct measures of gait and balance in post massive weight loss participants 3) the removal of excess skin will improve patient reported outcome measures using quality of life questionnaires in post massive weight loss participants 4) the removal of excess skin will improve aerobic capacity in post massive weight loss participants 5) the removal of excess skin does not change the body composition in post massive weight loss participants.
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Notify Me18 year–65 year
All sexes
Observational
Vancouver, British Columbia, V6T 1Z3, Canada
Participants will be recruited through multiple medical clinics and will visit the exercise, nutrition and muscle metabolism lab twice over the course of 8-12 weeks to complete objective and subjective measures of physical function. Each testing session will be conducted by the study investigator and physical function testing will be video recorded to reduce measurer bias. Based on participants' status they will be allocated to either a body contouring intervention group (BCI) or a post massive weight loss matched control (PMWMC). The first testing session would happen preoperatively and second one would happen between 8-12 weeks postoperatively depending on recovery required. Pain levels will be measured both pre and postoperatively using a numerical rating scale (0-10) to ensure adequate recovery.
Outcomes will include a variety of objective measures of physical function including 9-item modified physical performance test (mPPT), 30 second chair stand, timed up and go, stair climbing power, modified agility t-test, star excursion balance test, and 6 minute walk test. A body composition measure consisting of fat mass and fat free mass will also be obtained via dual-energy X-ray absorptiometry. Subjective measures would include 6 components of health related quality of life measure using BODY-Q questionnaire that would include sub scales such as body image, physical function, psychological, sexual, social, and obesity symptoms. Other subjective measure would include rate of perceived exertion which would be measured during each of the objective tests.
Additionally, grade of excess skin would be measured by images provided to the participants and weight of the resected excess skin will be obtained from the operating surgeon at the end of the study.
To obtain demographic history, physical activity level post surgery and to gain feedback for future clinical trial, the participants will also complete a socioeconomic status questionnaire, physical activity questionnaire, and participant experience with research questionnaire.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
These are surgeries that correct for excess skin and its adverse consequences. The surgeries that focus on central area to remove a large hanging pannus is usually called panniculectomies or abdominoplasties; the former is focused on the excision of excess tissue to relieve impairment while the latter is generally considered a cosmetic surgery. The form of the surgery is case dependent and can range from removing apron of skin to complete contouring of the abdomen with tightening of the abdominal muscle and moving the belly button.
Time frame: 8-12 weeks
Measured by 9-item modified physical performance test that gives an aggregate score out 36 and comprises of 9 tests pre and post surgery and includes the following:
Lowest score is 0, highest score is 36 and higher scores represent better outcomes.
Time frame: 8-12 weeks
Measured by number of stands completed during a 30 seconds chair stand pre and post surgery
Time frame: 8-12 weeks
Measured by time to complete a modified agility t-test pre and post surgery
Time frame: 8-12 weeks
Measured by time to complete a timed up and go test
Time frame: 8-12 weeks
Measured by time to ascend 10 stairs and deriving power pre and post surgery
Time frame: 8-12 weeks
Measured by star excursion balance test pre and post surgery
Time frame: 8-12 weeks
Measured by distance traveled during a 6 minute walk test pre and post surgery
Time frame: 8-12 weeks
Measured by change in bone free fat mass by using dual-energy X-ray absorptiometry pre and post surgery
Time frame: 8-12 weeks
Measured by using dual-energy X-ray absorptiometry pre and post surgery
Time frame: 8-12 weeks
Measured by 6 health related quality of life components of BODY-Q questionnaire pre and post surgery. Sub-scales would include body image, physical function, psychological, sexual, social, and obesity/physical symptoms. Each sub-scale will be graded individually, and the raw scores will be converted into a score from 0-100. For body image, physical function, psychological function, sexual, and social function higher scores represent a better outcome
For obesity/physical symptoms, symptoms will be added so that the total number of symptoms experienced would be obtained. Minimum number of symptoms is 0 and maximum is 10.
Time frame: 8-12 weeks
Measured by BORG RPE scale pre and post surgery. Minimum score is 6 and maximum is 20. The scale is only to provide how much the participants are being exerted when given a task.
Time frame: 8-12 weeks
Measured by linear models and correlating the degree of excess skin and change in measures of physical function scores from post to pre surgery
Time frame: 8-12 weeks
Measured by linear models and correlating the amount of weight of the resected excess skin and change in measures of physical function scores from post to pre surgery
University of British Columbia
Other
The Impact of Abdominal Body Contouring Surgery on Physical Function After a Massive Weight Loss: a Non-randomized Control Trial
Acronym: BCSP
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