Reducing Fall Risks for Adults With Obesity

Study 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).

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

Conditions
-----------------
Obesity, Bariatric Surgery Candidate, Gait, Unsteady

Intervention / Treatment
-----------------
* Behavioral: Obstacle crossing intervention for adults with obesity


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reducing Fall Risks in Obesity<br>Adults with obesity will be asked to perform the obstacle crossing intervention for adults with obesity for reducing falls risk. This will involve crossing obstacles of different heights 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 will be collected using a gait carpet and body-worn sensors. | Behavioral: Obstacle crossing intervention for adults with obesity<br>* The obstacle crossing intervention will be done for reducing falls risks in obesity. The intervention will provide gait practice to individuals with obesity who are eligible for and prior to weight loss surgery.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Velocity (cm/s) | walking speed | The change from baseline velocity (cm/s) at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cadence (steps per minute) | steps per minute | The change from baseline cadence (steps per minute) at 12 months | 
| Step width (cm) | lateral distance between feet | The change from baseline step width (cm) at 12 months | 
| single limb support time (msec) | time spent balancing on one leg | The change from baseline single limb support time (msec) at 12 months | 
| double limb support time (msec) | time spent balancing on both legs | The change from baseline double limb support time (msec) at 12 months | 
| step length (cm) | distance between consecutive steps | The change from baseline step length (cm) at 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, gait, bariatric surgery, walking, obstacles