Clinical trial NCT03558100: Reducing Fall Risks for Adults With Obesity
Official title: A Nonrandomized Controlled Trial of an Obstacle Crossing Intervention for Adults Before Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Bariatric Surgery Candidate
Gait, Unsteady
Keywords: obesity
gait
bariatric surgery
walking
obstacles
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2018-06-15
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Velocity (cm/s)
timeFrame: The change from baseline velocity (cm/s) at 12 months
Secondary outcomes:
measure: Cadence (steps per minute)
timeFrame: The change from baseline cadence (steps per minute) at 12 months
measure: Step width (cm)
timeFrame: The change from baseline step width (cm) at 12 months
measure: single limb support time (msec)
timeFrame: The change from baseline single limb support time (msec) at 12 months
measure: double limb support time (msec)
timeFrame: The change from baseline double limb support time (msec) at 12 months
measure: step length (cm)
timeFrame: The change from baseline step length (cm) at 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Boston University Charles River Campus
name: Simone V Gill
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gill SV, Walsh MK, Pratt JA, Toosizadeh N, Najafi B, Travison TG. Changes in spatiotemporal gait patterns during flat ground walking and obstacle crossing 1 year after bariatric surgery. Surg Obes Relat Dis. 2016 Jun;12(5):1080-1085. doi: 10.1016/j.soard.2016.03.029. Epub 2016 Mar 30.