ObesityNCT05358288
Effect of Bariatric Surgery on Physical Activity, Gait, Flexibility and Quality of Life
An observational study of Obesity and Bariatric Surgery, run by Ankara Yildirim Beyazıt University.
Trial summary
This study aimed to analyze spatio-temporal characteristics of gait, physical activity level and changes in quality of life in patients by measuring conditions before bariatric surgery and third-month after the surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Bariatric Surgery, Gait
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 27 May 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: -Having obestity with BMI>35 (indication for bariatric surgery)
Who may be able to join
- Diagnosis of obesity
- Body mass index > 35
- Speak and understand Turkish
- Ability of read and write
Who cannot join
- History of lower extremity surgery
- Musculoskeletal/systemic/neurological/psychiatric problems
- Urinary syndromes
- Limited gait due to cardio-pulmonary insufficiency
- Unwillingness to participate
About this study
Official title: Investigation of the Effect of Bariatric Surgery on Physical Activity Levels, Spatiotemporal Parameters of Gait, Flexibility and Quality of Life
This study aimed to analyze spatio-temporal characteristics of gait, physical activity level and changes in quality of life in patients by measuring conditions before bariatric surgery and third-month after the surgery.
- Conditions
- Obesity, Bariatric Surgery, Gait
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
Participants's gait speed were evaluated by a wearable sensor. This wearable sensor is named BTS G-Walk sensor (BTS Bioengineering S.p.A., Italy) and was attached L4-5 region by a belt. The data were transferred by Bluetooth connection to software while participants' walking.
Measured: Change from baseline at 3 months
Secondary outcomes (7)
Support times
Participants's support times of gait were evaluated by a wearable sensor. The wearable sensor is named BTS G-Walk sensor (BTS Bioengineering S.p.A.,Italy) and was attached L4-5 region by a belt. The data were transferred by Bluetooth connection to software while participants' walking.
Measured: Change from baseline at 3 months
Step Length
Participants's step lengths of gait were evaluated by a wearable sensor. The wearable sensor is named BTS G-Walk sensor (BTS Bioengineering S.p.A.,Italy) and was attached L4-5 region by a belt. The data were transferred by Bluetooth connection to software while participants' walking.
Measured: Change from baseline at 3 months
Levels of physical activity
Physical activity levels were evaluated by the International Physical Activity Questionnaire- Short Form. This form include seven questions. With these questions, it is possible to obtain information about the time individuals spend in walking, moderate and vigorous activities and also time spent sitting. As a result of the calculations, the level of physical activity is divided into three groups. These groups are as follows: Less than 600 metabolic equivalent-minute inactive; between 600-3000 metabolic equivalent-minute are minimum active; more than 3000 metabolic equivalent-minute are very active.
Measured: Change from baseline at 3 months
Sit-Reach Test
The flexibility of the lumbar extensors, hamstrings and gastrocsoleus muscle group was evaluated with the Sit-to-Sit Test. Individuals were asked to sit in a long sitting position, hold their feet in 90 degrees dorsiflexion and reach for their toes with their hands without bending their knees. The test was repeated three times and the mean value was recorded. Positive values were used if this value reached beyond the toes. Higher positive values indicate better flexibility.
Measured: Change from baseline at 3 months
Modified Thomas Test
Flexibility in the Rectus Femoris and Iliopsoas muscles evaluated with "Modified Thomas Test". While bringing her hip to maximum flexion with her hands, she was asked to lower the extremity to be tested towards the ground. Measurements were repeated 3 times for each extremity and these values were average was taken. Measurements were made with a goniometer. Higher values indicate better flexibility.
Measured: Change from baseline at 3 months
Popliteal Angle
Popliteal angle measurement was used for hamstring shortness. The measurement was performed with the participants in supine position with the goniometer zeroed to the anterolateral half of the tibia and the hip stabilized at 90 degrees of flexion. The average of two measurements taken five seconds apart was taken. Values above 20 degrees were considered as hamstring shortness.
Measured: Change from baseline at 3 months
Quality of Life
The Impact of Weight on Quality of Life Questionnaire (IWQOL) was used to assess the participants' quality of life. The scale includes questions on bodily functions, self-esteem, sexual life, social pressure and work. The minimum score that can be obtained from the scale consisting of 31 items in total is 0 and the maximum score is 100. A lower score indicates a lower quality of life.
Measured: Change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 Oct 2016
- Primary completion30 May 2017
- Study completion27 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358288
- Sponsor's protocol ID
- 2018-235/30
- Status last verified
- Jun 2023
- First submitted
- 22 Apr 2022
- Last updated
- 12 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Bariatric Surgery on Physical Activity Levels, Spatiotemporal Parameters of Gait, Flexibility and Quality of Life
- ClinicalTrials.gov ID
- NCT05358288
- Acronym / sponsor ID
- 2018-235/30
- Conditions
- Obesity, Bariatric Surgery, Gait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 27 May 2019 (actual)
- First posted
- 3 May 2022 (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.
This study aimed to analyze spatio-temporal characteristics of gait, physical activity level and changes in quality of life in patients by measuring conditions before bariatric surgery and third-month after the surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- -Having obestity with BMI>35 (indication for bariatric surgery)
Key inclusion criteria (4 listed)
- Diagnosis of obesity
- Body mass index > 35
- Speak and understand Turkish
- Ability of read and write
Key exclusion criteria (5 listed)
- History of lower extremity surgery
- Musculoskeletal/systemic/neurological/psychiatric problems
- Urinary syndromes
- Limited gait due to cardio-pulmonary insufficiency
- Unwillingness to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gait speed
Time frame: Change from baseline at 3 months
Participants's gait speed were evaluated by a wearable sensor. This wearable sensor is named BTS G-Walk sensor (BTS Bioengineering S.p.A., Italy) and was attached L4-5 region by a belt. The data were transferred by Bluetooth connection to software while participants' walking.
7 secondary outcomes
Support times
Time frame: Change from baseline at 3 months
Step Length
Time frame: Change from baseline at 3 months
Levels of physical activity
Time frame: Change from baseline at 3 months
Sit-Reach Test
Time frame: Change from baseline at 3 months
Modified Thomas Test
Time frame: Change from baseline at 3 months
Popliteal Angle
Time frame: Change from baseline at 3 months
Quality of Life
Time frame: Change from baseline at 3 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 12 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Bariatric Surgery, run by Ankara Yildirim Beyazıt University.
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 4 inclusion and 5 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 12 Jun 2023. 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?
Gait speed (time frame: Change from baseline at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2023.