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

NCT ID: NCT01447316

Last Updated: 2013-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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).

Conditions

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Obesity, Morbid

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Bariatric surgery

Patients undergoing bariatric surgery for weight loss.

Subject outcomes following bariatric surgery

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather K Vincent, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida Department of Orthopaedics and Rehabilitation

Locations

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UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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332-2009

Identifier Type: -

Identifier Source: org_study_id

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