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

Obesity, Morbid Clinical Trial

Official title:

Impact of Bariatric Surgery on Short Term Weight Loss- Related Changes in Gait and Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447316
• Other study ID #: 332-2009
• Status: Completed
• Phase: N/A
• First received: October 4, 2011
• Last updated: January 16, 2013
• Start date: August 2009
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Other:
• Subject outcomes following bariatric surgery
Subject outcomes (body composition, gait analysis, lower extremity joint pain and perceived quality of life) measured at per-op, 2, 4 weeks and 3 months.

Locations

Country	Name	City	State
United States	UF&Shands Orthopaedics and Sports Medicine Institute	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Composition, describes change in body composition from pre-op levels	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.	Describes change over a period of 4 weeks; measured at pre-op, 2 and 4 weeks following surgery	No
Secondary	Gait Analysis, describes change in gait parameters from pre-op levels	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.	Describes changes in gait parameters over a 3 month period; measured at pre-op, 4 weeks and 3 months following surgery.	No
Secondary	Lower Extremity Joint Pain, describes change from pre-op using a Visual Analog Scale (VAS).	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.	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	No
Secondary	Medical Outcomes Short Form (SF-36), describes change in perceived quality of life (QOL)	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).	Describes perceived (QOL) over a period of 3 months, measured at pre-op, 4 weeks and 3 months following surgery	No