Reducing Fall Risks for Adults With Obesity

Obesity Clinical Trial

— ObesityFalls  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558100
• Other study ID #: 3820E
• Secondary ID: R03AR066344-01A1
• Status: Completed
• Phase: N/A
• Start date: September 1, 2014
• Est. completion date: July 15, 2019

Study information

• Verified date: July 2019
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Gait Disorders, Neurologic
• Gait, Unsteady
• Obesity

Intervention

Behavioral:
• Obstacle 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Velocity (cm/s)	walking speed	The change from baseline velocity (cm/s) at 12 months
Secondary	Cadence (steps per minute)	steps per minute	The change from baseline cadence (steps per minute) at 12 months
Secondary	Step width (cm)	lateral distance between feet	The change from baseline step width (cm) at 12 months
Secondary	single limb support time (msec)	time spent balancing on one leg	The change from baseline single limb support time (msec) at 12 months
Secondary	double limb support time (msec)	time spent balancing on both legs	The change from baseline double limb support time (msec) at 12 months
Secondary	step length (cm)	distance between consecutive steps	The change from baseline step length (cm) at 12 months