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出境医 / 临床实验 / Reducing Fall Risks for Adults With Obesity (ObesityFalls)

Reducing Fall Risks for Adults With Obesity (ObesityFalls)

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
Obesity Bariatric Surgery Candidate Gait, Unsteady Behavioral: Obstacle crossing intervention for adults with obesity Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : September 1, 2014
Actual Primary Completion Date : July 15, 2019
Actual Study Completion Date : July 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) [ Time Frame: The change from baseline velocity (cm/s) at 12 months ]
    walking speed


Secondary Outcome Measures :
  1. Cadence (steps per minute) [ Time Frame: The change from baseline cadence (steps per minute) at 12 months ]
    steps per minute

  2. Step width (cm) [ Time Frame: The change from baseline step width (cm) at 12 months ]
    lateral distance between feet

  3. single limb support time (msec) [ Time Frame: The change from baseline single limb support time (msec) at 12 months ]
    time spent balancing on one leg

  4. double limb support time (msec) [ Time Frame: The change from baseline double limb support time (msec) at 12 months ]
    time spent balancing on both legs

  5. step length (cm) [ Time Frame: The change from baseline step length (cm) at 12 months ]
    distance between consecutive steps


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Sponsors and Collaborators
Boston University Charles River Campus
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Layout table for investigator information
Principal Investigator: Simone V Gill Boston University Charles River Campus
Tracking Information
First Submitted Date  ICMJE May 25, 2018
First Posted Date  ICMJE June 15, 2018
Last Update Posted Date July 18, 2019
Actual Study Start Date  ICMJE September 1, 2014
Actual Primary Completion Date July 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2018)
Velocity (cm/s) [ Time Frame: The change from baseline velocity (cm/s) at 12 months ]
walking speed
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2018)
  • Cadence (steps per minute) [ Time Frame: The change from baseline cadence (steps per minute) at 12 months ]
    steps per minute
  • Step width (cm) [ Time Frame: The change from baseline step width (cm) at 12 months ]
    lateral distance between feet
  • single limb support time (msec) [ Time Frame: The change from baseline single limb support time (msec) at 12 months ]
    time spent balancing on one leg
  • double limb support time (msec) [ Time Frame: The change from baseline double limb support time (msec) at 12 months ]
    time spent balancing on both legs
  • step length (cm) [ Time Frame: The change from baseline step length (cm) at 12 months ]
    distance between consecutive steps
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Fall Risks for Adults With Obesity
Official Title  ICMJE A Nonrandomized Controlled Trial of an Obstacle Crossing Intervention for Adults Before Bariatric Surgery
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Bariatric Surgery Candidate
  • Gait, Unsteady
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: Obstacle crossing intervention for adults with obesity
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 15, 2019
Actual Primary Completion Date July 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03558100
Other Study ID Numbers  ICMJE 3820E
R03AR066344-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Simone V. Gill, Boston University Charles River Campus
Study Sponsor  ICMJE Boston University Charles River Campus
Collaborators  ICMJE National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators  ICMJE
Principal Investigator: Simone V Gill Boston University Charles River Campus
PRS Account Boston University Charles River Campus
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP