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

January 16, 2013 updated by: University of Florida

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32607
        • UF&Shands Orthopaedics and Sports Medicine Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All subjects will be patients already scheduled to undergo bariatric surgery for weight loss.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bariatric surgery
Patients undergoing bariatric surgery for weight loss.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Composition, describes change in body composition from pre-op levels
Time Frame: 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.
Describes change over a period of 4 weeks; measured at pre-op, 2 and 4 weeks following surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait Analysis, describes change in gait parameters from pre-op levels
Time Frame: 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.
Describes changes in gait parameters over a 3 month period; measured at pre-op, 4 weeks and 3 months following surgery.
Lower Extremity Joint Pain, describes change from pre-op using a Visual Analog Scale (VAS).
Time Frame: 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.
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
Medical Outcomes Short Form (SF-36), describes change in perceived quality of life (QOL)
Time Frame: 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).
Describes perceived (QOL) over a period of 3 months, measured at pre-op, 4 weeks and 3 months following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

October 4, 2011

First Submitted That Met QC Criteria

October 5, 2011

First Posted (Estimate)

October 6, 2011

Study Record Updates

Last Update Posted (Estimate)

January 17, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 332-2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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