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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
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, gait, bariatric surgery, walking, obstacles

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

    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)
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    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

    Learn more about this trial

    Reducing Fall Risks for Adults With Obesity

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