Clinical trial NCT04516473: The Impact of Abdominal Body Contouring Surgery on Physical Function After a Massive Weight Loss (BCSP)
Official title: The Impact of Abdominal Body Contouring Surgery on Physical Function After a Massive Weight Loss: a Non-randomized Control Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Loss
Obesity
Keywords: Panniculectomy
Excess Skin
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female who have undergone a massive weight loss through any weight loss intervention, have excess skin, are healthy enough to perform simple physical function tasks and self-selected to undergo abdominal skin removal surgery.

Participants who have similar criteria to the intervention group but will not undergo surgical intervention during the course of the study will serve as a control group.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Weight has not deviated by greater than 5 percent for 3 months
* Have excess grade skin of greater or equal to 2
* Percent total weight loss pre-body contouring of greater or equal to 25 percent
* Fluently read and write English

Exclusion Criteria:

* Any musculoskeletal issues that would prevent participants from doing the physical function tests.
* Current medication history indicating atypical antipsychotics including but not limited to clozapine, olanzapine, quetiapine, risperidone, aripiprazole, amisulpride, ziprasidone, asenapine, iloperidone, lurasidone and paliperidone.
* Severe pulmonary conditions such as severe chronic obstructive pulmonary disease (COPD) and or severe asthma.
* Participants who actively aiming to lose weight
* Have diabetes with diabetic neuropathy or experienced hypoglycemic event within 6 months prior to the study
* Severe kidney disease with estimated glomerular filtration rate (eGFR) less than 60 ml/min
* Pregnant individuals
* Uncontrolled hypertension with resting blood pressure greater than 160/90 mmHg
* Uncontrolled obstructive sleep apnea with symptoms
* On statin therapy with myopathy
* Unstable atrial fibrillation
* Weight pre-body contouring greater than 340 lbs (154 kg)
* Current smoker

Primary outcomes:
measure: Change in physical function aggregate score
timeFrame: 8-12 weeks
Secondary outcomes:
measure: Change in lower body strength
timeFrame: 8-12 weeks
measure: Change in time to complete agility drill
timeFrame: 8-12 weeks
measure: Change in timed up and go
timeFrame: 8-12 weeks
measure: Change in stair climbing power
timeFrame: 8-12 weeks
measure: Change in dynamic balance balance
timeFrame: 8-12 weeks
measure: Change in aerobic capacity
timeFrame: 8-12 weeks
measure: Change in lean body mass
timeFrame: 8-12 weeks
measure: Change in fat mass
timeFrame: 8-12 weeks
measure: Change in patient reported outcome measure of physical function and quality of life
timeFrame: 8-12 weeks
measure: Change in rate of perceived exertion (RPE) during physical function tests
timeFrame: 8-12 weeks
Other outcomes:
measure: Correlation between degree of excess skin and change in objective physical function test scores
timeFrame: 8-12 weeks
measure: Correlation between the weight of resected excess skin and change in objective physical function tests
timeFrame: 8-12 weeks
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: Assistant Professor University of British Columbia
name: Cameron Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
References: