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NCT Number: NCT01447316

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

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.

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Key information

Conditions

Obesity, Morbid Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subject outcomes following bariatric surgery

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Oct 6, 2011
Registry last updated
Jan 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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