Clinical trial NCT01447316: Bariatric Surgery on Short Term Weight Loss- Related Changes in Gait
Official title: Impact of Bariatric Surgery on Short Term Weight Loss- Related Changes in Gait and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Keywords: body composition
gait
quality of life
Patients
undergoing
bariatric surgery.
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2011-10-06
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects will be patients already scheduled to undergo bariatric surgery for weight loss.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Body Composition, describes change in body composition from pre-op levels
timeFrame: Describes change over a period of 4 weeks; measured at pre-op, 2 and 4 weeks following surgery
Secondary outcomes:
measure: Gait Analysis, describes change in gait parameters from pre-op levels
timeFrame: Describes changes in gait parameters over a 3 month period; measured at pre-op, 4 weeks and 3 months following surgery.
measure: Lower Extremity Joint Pain, describes change from pre-op using a Visual Analog Scale (VAS).
timeFrame: 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
measure: Medical Outcomes Short Form (SF-36), describes change in perceived quality of life (QOL)
timeFrame: Describes perceived (QOL) over a period of 3 months, measured at pre-op, 4 weeks and 3 months following surgery
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF&Shands Orthopaedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: University of Florida Department of Orthopaedics and Rehabilitation
name: Heather K Vincent, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: