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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01447316
First received: October 4, 2011
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Obesity, Morbid
Other: Subject outcomes following bariatric surgery

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of Bariatric Surgery on Short Term Weight Loss- Related Changes in Gait and Quality of Life

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 36
Study Start Date: August 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447316

Locations
United States, Florida
UF&Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States, 32607
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Heather K Vincent, Ph.D. University of Florida Department of Orthopaedics and Rehabilitation
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01447316     History of Changes
Other Study ID Numbers: 332-2009
Study First Received: October 4, 2011
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
body composition
gait
quality of life
Patients
undergoing
bariatric surgery.

Additional relevant MeSH terms:
Obesity, Morbid
Weight Loss
Body Weight
Body Weight Changes
Nutrition Disorders
Obesity
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014