Obesity, Morbid Clinical Trial
Official title:
Impact of Bariatric Surgery on Short Term Weight Loss- Related Changes in Gait and Quality of Life
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 |
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.
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | UF&Shands Orthopaedics and Sports Medicine Institute | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
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 PODĀ®) 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 (GaitRiteĀ®). 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 |
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