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Completed

NCT Number: NCT03558100

Reducing Fall Risks for Adults With Obesity

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Obstacle crossing intervention for adults with obesity

Behavioral

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 outcomes

  1. Velocity (cm/s)

    Time frame: The change from baseline velocity (cm/s) at 12 months

    walking speed

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

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

Acronym: ObesityFalls

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jun 15, 2018
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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