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Clinical Trials/NCT03558100
NCT03558100
Completed
Not Applicable

A Nonrandomized Controlled Trial of an Obstacle Crossing Intervention for Adults Before Bariatric Surgery

Boston University Charles River Campus0 sites100 target enrollmentSeptember 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Boston University Charles River Campus
Enrollment
100
Primary Endpoint
Velocity (cm/s)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The objective of the clinical study was to examine if practice could improve walking patterns associated with fall risks before patients with obesity underwent weight loss surgery. We hypothesized that patients would show improvements in their walking after completing the intervention. For the intervention, patients walked under five conditions: on flat ground at the beginning of the study, crossing three obstacle heights, and on flat ground at the end of the study for a total of 25 times.

Detailed Description

Obesity has a negative impact on aspects of walking associated with fall risks. After weight loss surgery, adults show improvements in walking. However, those who undergo surgery still show deficits in walking and an additional group of individuals do not undergo the procedure. Our objective was to examine if practice could improve gait patterns associated with fall risks before patients underwent weight loss surgery. Adults with obese body mass index between 30 to 60 years old who were eligible to undergo the Roux-en-Y weight loss surgery procedure walked under five conditions: initial baseline walking on flat ground, crossing three obstacle heights, and final baseline walking on flat ground for a total of 25 trials. Spatio-temporal gait parameters were collected using a gait carpet and body-worn sensors. The GAITRite mat was a 4.9 m long x 0.6 m wide pressure-sensitive mat with a temporal resolution of 120 Hz and a spatial resolution of 1.3 cm. LEGSysTM includes five wearable sensors containing triaxial gyroscopes, accelerometers, and magnetometers. Dependent variables selected included velocity (cm/s), cadence (steps/minute), step length (distance between consecutive steps), step width (lateral distance between feet), single limb support time (amount of time spent on one leg during the walking cycle), and double limb support time (amount of time spend on two legs during the walking cycle).

Registry
clinicaltrials.gov
Start Date
September 1, 2014
End Date
July 15, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Boston University Charles River Campus
Responsible Party
Principal Investigator
Principal Investigator

Simone V. Gill

Associate Professor

Boston University Charles River Campus

Eligibility Criteria

Inclusion Criteria

  • between 30 and 60 years old
  • eligible to undergo Roux-en-Y gastric bypass surgery
  • walk independently without assistive devices

Exclusion Criteria

  • scheduled to undergo knee surgery
  • receiving dialysis
  • being treated for cancer

Outcomes

Primary Outcomes

Velocity (cm/s)

Time Frame: The change from baseline velocity (cm/s) at 12 months

walking speed

Secondary Outcomes

  • Cadence (steps per minute)(The change from baseline cadence (steps per minute) at 12 months)
  • Step width (cm)(The change from baseline step width (cm) at 12 months)
  • double limb support time (msec)(The change from baseline double limb support time (msec) at 12 months)
  • single limb support time (msec)(The change from baseline single limb support time (msec) at 12 months)
  • step length (cm)(The change from baseline step length (cm) at 12 months)

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