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Reducing Fall Risks for Adults With Obesity

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03558100
Acronym
ObesityFalls
Enrollment
100
Registered
2018-06-15
Start date
2014-09-01
Completion date
2019-07-15
Last updated
2019-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Gait, Unsteady, Obesity

Keywords

obesity, gait, bariatric surgery, walking, obstacles

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).

Interventions

BEHAVIORALObstacle crossing intervention for adults with obesity

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.

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
Boston University Charles River Campus
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Velocity (cm/s)The change from baseline velocity (cm/s) at 12 monthswalking speed

Secondary

MeasureTime frameDescription
Cadence (steps per minute)The change from baseline cadence (steps per minute) at 12 monthssteps per minute
Step width (cm)The change from baseline step width (cm) at 12 monthslateral distance between feet
single limb support time (msec)The change from baseline single limb support time (msec) at 12 monthstime spent balancing on one leg
double limb support time (msec)The change from baseline double limb support time (msec) at 12 monthstime spent balancing on both legs
step length (cm)The change from baseline step length (cm) at 12 monthsdistance between consecutive steps

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026