Bariatric Surgery on Short Term Weight Loss- Related Changes in Gait

Completed

• Conditions: Obesity, Morbid
• Interventions: Other: Subject outcomes following bariatric surgery

• Registration Number: NCT01447316
• Lead Sponsor: University of Florida

Brief Summary

This is a short term study of the effects of bariatric surgery on body composition, gait parameters during walking, lower extremity joint pain and quality of life (QOL) in morbidly obese patients who are already scheduled for a bariatric surgical procedure.

Detailed Description

This is a prospective, exploratory, short term study of the effects of bariatric surgery on body composition, gait parameters during walking, lower extremity joint pain and quality of life (QOL) in morbidly obese patients. All patients who enroll have already agreed to undergo the bariatric procedure with their respective surgeon; the study team will simply follow specific outcome measures in addition to their normal clinical care at two time points after the surgery (week 4 and month 3).

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-05
• Study First Posted: 2011-10-06
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-16
• Last Update Posted: 2013-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• no urgent need for bariatric procedure
• 21-65 years of age
• body mass index (BMI) 35 kg/m2 or greater, defined as morbid obesity
• waist circumference of < 66 inches
• able to walk independently

Exclusion Criteria

• < 21 or > 65 years of age
• pregnancy; psychiatric conditions; binge eating patterns; Prader-Willi syndrome; drug dependency; dementia or other neurodegenerative diseases that would preclude appropriate cognitive or physical ability to perform study protocol
• uncontrolled diabetes (not using meds)
• waist circumference of > 66 inches
• orthopedic conditions that prevent ambulation (severe painful osteoarthritis of the hip or knee)
• patient is wheelchair bound

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bariatric surgery	Subject outcomes following bariatric surgery	Patients undergoing bariatric surgery for weight loss.

Primary Outcome Measures

Name	Time	Method
Body Composition, describes change in body composition from pre-op levels	Describes change over a period of 4 weeks; measured at pre-op, 2 and 4 weeks following surgery	To track changes in body composition and mass during the study, body weight body fat mass, fat free mass will be collected prior to and 2 and 4 weeks after the bariatric surgery using air plethysmography. Air plethysmography (using the BOD POD®) is a reliable technique of body volume and composition, and has been validated for use in obese individuals and is highly correlated to the gold standard of body composition assessment, underwater weighing.

Secondary Outcome Measures

Name	Time	Method
Gait Analysis, describes change in gait parameters from pre-op levels	Describes changes in gait parameters over a 3 month period; measured at pre-op, 4 weeks and 3 months following surgery.	The gait analysis involves walking on a 26' long portable gait mat (GaitRite®). The mat is a cushioned thin mat filled with pressure sensors. Participants will be asked to walk at a self-selected, comfortable pace across the 26 foot long mat. This normal self-selected pace will be performed three times and the values will be averaged for the three trials. The participant will then be asked to walk as quickly as possible across the mat and the velocity to reach 20' will be determined. This will be repeated two more times for a total of 3 trials.
Lower Extremity Joint Pain, describes change from pre-op using a Visual Analog Scale (VAS).	Describes change in lower extremity joint pain over a period of 3 months; measured with a (VAS) at per-op, 4 weeks and 3 months following surgery	Joint pain intensity will be self-assessed by a 10 cm (VAS) with terminal descriptors (anchors of 0 cm = no pain; 10 cm = worst possible pain). The (VAS) is an accepted outcome measure for chronic pain.
Medical Outcomes Short Form (SF-36), describes change in perceived quality of life (QOL)	Describes perceived (QOL) over a period of 3 months, measured at pre-op, 4 weeks and 3 months following surgery	The (SF36) is an instrument that assesses overall health-related (QOL). The (SF36) is comprised of eight subscales, each ranging from 0-100 points, with higher scores representing better health. The (SF36) has been recommended for use following bariatric surgery to capture meaningful changes in (QOL).

Trial Locations

Locations (1)

UF&Shands Orthopaedics and Sports Medicine Institute; 🇺🇸 Gainesville, Florida, United States