ObesityObesityFallsNCT03558100
Reducing Fall Risks for Adults With Obesity
A study testing Obstacle crossing intervention for adults with obesity in people with Obesity and Bariatric Surgery Candidate, run by Boston University Charles River Campus.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate, Gait, Unsteady
- What is being tested?
- Obstacle crossing intervention for adults with obesity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 15 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- between 30 and 60 years old
- eligible to undergo Roux-en-Y gastric bypass surgery
- walk independently without assistive devices
Who cannot join
- scheduled to undergo knee surgery
- receiving dialysis
- being treated for cancer
About this study
Official title: A Nonrandomized Controlled Trial of an Obstacle Crossing Intervention for Adults Before Bariatric Surgery
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.
Read the 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).
- Conditions
- Obesity, Bariatric Surgery Candidate, Gait, Unsteady
- Being tested
- Obstacle crossing intervention for adults with obesity
- Keywords
- obesity, gait, bariatric surgery, walking, obstacles
- Medical subject headings
- Obesity, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstacle crossing intervention for adults with obesityBehavioural
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 group | Role | What they receive |
|---|---|---|
| Reducing Fall Risks in Obesity | Experimental | 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. Receives: Behavioral: Obstacle crossing intervention for adults with obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Velocity (cm/s)
walking speed
Measured: The change from baseline velocity (cm/s) at 12 months
Secondary outcomes (5)
Cadence (steps per minute)
steps per minute
Measured: The change from baseline cadence (steps per minute) at 12 months
Step width (cm)
lateral distance between feet
Measured: The change from baseline step width (cm) at 12 months
single limb support time (msec)
time spent balancing on one leg
Measured: The change from baseline single limb support time (msec) at 12 months
double limb support time (msec)
time spent balancing on both legs
Measured: The change from baseline double limb support time (msec) at 12 months
step length (cm)
distance between consecutive steps
Measured: The change from baseline step length (cm) at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 Sep 2014
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Simone V. Gill, Boston University Charles River Campus
- Investigators
- Simone V Gill, Principal investigator, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558100
- Sponsor's protocol ID
- 3820E
- Other IDs
- R03AR066344-01A1
- Acronym
- ObesityFalls
- Status last verified
- Jul 2019
- First submitted
- 25 May 2018
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 27320220
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nonrandomized Controlled Trial of an Obstacle Crossing Intervention for Adults Before Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03558100
- Acronym / sponsor ID
- ObesityFalls / 3820E
- Conditions
- Obesity, Bariatric Surgery Candidate, Gait, Unsteady
- Keywords
- obesity, gait, bariatric surgery, walking, obstacles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reducing Fall Risks in Obesity | Experimental | Behavioral: Obstacle crossing intervention for adults with obesityAdults 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- between 30 and 60 years old
- eligible to undergo Roux-en-Y gastric bypass surgery
- walk independently without assistive devices
Key exclusion criteria (3 listed)
- scheduled to undergo knee surgery
- receiving dialysis
- being treated for cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obstacle crossing intervention for adults with obesityThe 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. | Behavioural | Reducing Fall Risks in Obesity |
Primary outcome
Velocity (cm/s)
Time frame: The change from baseline velocity (cm/s) at 12 months
walking speed
5 secondary outcomes
Cadence (steps per minute)
Time frame: The change from baseline cadence (steps per minute) at 12 months
Step width (cm)
Time frame: The change from baseline step width (cm) at 12 months
single limb support time (msec)
Time frame: The change from baseline single limb support time (msec) at 12 months
double limb support time (msec)
Time frame: The change from baseline double limb support time (msec) at 12 months
step length (cm)
Time frame: The change from baseline step length (cm) at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Results publication: PubMed 27320220Gill 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone V Gill principal investigator
Boston University Charles River Campus
Questions about this trial
What is this clinical trial studying?
A study testing Obstacle crossing intervention for adults with obesity in people with Obesity and Bariatric Surgery Candidate, run by Boston University Charles River Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Velocity (cm/s) (time frame: The change from baseline velocity (cm/s) at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03558100, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.