Reducing Fall Risks for Adults With Obesity (ObesityFalls)
Primary Purpose
Obesity, Bariatric Surgery Candidate, Gait, Unsteady
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Obstacle crossing intervention for adults with obesity
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity, gait, bariatric surgery, walking, obstacles
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Reducing Fall Risks in Obesity
Arm Description
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.
Outcomes
Primary Outcome Measures
Velocity (cm/s)
walking speed
Secondary Outcome Measures
Cadence (steps per minute)
steps per minute
Step width (cm)
lateral distance between feet
single limb support time (msec)
time spent balancing on one leg
double limb support time (msec)
time spent balancing on both legs
step length (cm)
distance between consecutive steps
Full Information
NCT ID
NCT03558100
First Posted
May 25, 2018
Last Updated
July 17, 2019
Sponsor
Boston University Charles River Campus
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT03558100
Brief Title
Reducing Fall Risks for Adults With Obesity
Acronym
ObesityFalls
Official Title
A Nonrandomized Controlled Trial of an Obstacle Crossing Intervention for Adults Before Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2014 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
July 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University Charles River Campus
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Bariatric Surgery Candidate, Gait, Unsteady
Keywords
obesity, gait, bariatric surgery, walking, obstacles
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reducing Fall Risks in Obesity
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Obstacle crossing intervention for adults with obesity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Velocity (cm/s)
Description
walking speed
Time Frame
The change from baseline velocity (cm/s) at 12 months
Secondary Outcome Measure Information:
Title
Cadence (steps per minute)
Description
steps per minute
Time Frame
The change from baseline cadence (steps per minute) at 12 months
Title
Step width (cm)
Description
lateral distance between feet
Time Frame
The change from baseline step width (cm) at 12 months
Title
single limb support time (msec)
Description
time spent balancing on one leg
Time Frame
The change from baseline single limb support time (msec) at 12 months
Title
double limb support time (msec)
Description
time spent balancing on both legs
Time Frame
The change from baseline double limb support time (msec) at 12 months
Title
step length (cm)
Description
distance between consecutive steps
Time Frame
The change from baseline step length (cm) at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simone V Gill
Organizational Affiliation
Boston University Charles River Campus
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27320220
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.
Results Reference
result
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Reducing Fall Risks for Adults With Obesity
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