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ObesityFalls: Reducing Fall Risks for Adults With Obesity

Sponsor
Boston University Charles River Campus (Other)
Overall Status
Completed
CT.gov ID
NCT03558100
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
100
Enrollment
1
Arm
58.4
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Obstacle crossing intervention for adults with obesity
 N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Nonrandomized Controlled Trial of an Obstacle Crossing Intervention for Adults Before Bariatric Surgery
Actual Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Jul 15, 2019
Actual Study Completion Date :
Jul 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Reducing Fall Risks in Obesity

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
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.

Outcome Measures

Primary Outcome Measures

  1. Velocity (cm/s) [The change from baseline velocity (cm/s) at 12 months]

    walking speed

Secondary Outcome Measures

  1. Cadence (steps per minute) [The change from baseline cadence (steps per minute) at 12 months]

    steps per minute

  2. Step width (cm) [The change from baseline step width (cm) at 12 months]

    lateral distance between feet

  3. single limb support time (msec) [The change from baseline single limb support time (msec) at 12 months]

    time spent balancing on one leg

  4. double limb support time (msec) [The change from baseline double limb support time (msec) at 12 months]

    time spent balancing on both legs

  5. step length (cm) [The change from baseline step length (cm) at 12 months]

    distance between consecutive steps

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 60 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Simone V Gill, Boston University Charles River Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Simone V. Gill, Associate Professor, Boston University Charles River Campus
ClinicalTrials.gov Identifier:
NCT03558100
Other Study ID Numbers:
  • 3820E
  • R03AR066344-01A1
First Posted:
Jun 15, 2018
Last Update Posted:
Jul 18, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Simone V. Gill, Associate Professor, Boston University Charles River Campus
obesity
gait
bariatric surgery
walking
obstacles
Additional relevant MeSH terms:
Gait Disorders, Neurologic
Obesity

Study Results

No Results Posted as of Jul 18, 2019