The Impact of Abdominal Body Contouring Surgery on Physical Function After a Massive Weight Loss (BCSP)

NCT ID: NCT04516473

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-18
• Study Completion Date: 2021-12-29

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.

Conditions

Weight Loss; Obesity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental/Body Contouring Intervention

These are participants who have self-selected to undergo an abdominal body contouring procedure within the course of the study.

Abdominal Body Contouring

Intervention Type: PROCEDURE

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.

Control/Post Massive Weight Loss Matched Control

These are participants who have similar characteristics to the body contouring intervention group, but they will not undergo any surgical procedure during the course of the study.

The addition of this matched control group with a similar degree of excess skin but who will not be undergoing body contouring surgery will control for any changes in physical function which may occur without any intervention within the testing sessions. This group will also control for any learning effects between testing sessions.

No interventions assigned to this group

Interventions

Abdominal Body Contouring

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Cameron Mitchell

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cameron Mitchell, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor University of British Columbia

Locations

University of British Columbia

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H20-00960

Identifier Type: -

Identifier Source: org_study_id