Effect of Bariatric Surgery on Physical Activity, Gait, Flexibility and Quality of Life

June 9, 2023 updated by: Ankara Yildirim Beyazıt University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

-Having obestity with BMI>35 (indication for bariatric surgery)

Description

Inclusion Criteria:

  • Diagnosis of obesity
  • Body mass index > 35
  • Speak and understand Turkish
  • Ability of read and write

Exclusion Criteria:

  • History of lower extremity surgery
  • Musculoskeletal/systemic/neurological/psychiatric problems
  • Urinary syndromes
  • Limited gait due to cardio-pulmonary insufficiency
  • Unwillingness to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from baseline at 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Support times
Time Frame: Change from baseline at 3 months
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.
Change from baseline at 3 months
Step Length
Time Frame: Change from baseline at 3 months
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.
Change from baseline at 3 months
Levels of physical activity
Time Frame: Change from baseline at 3 months
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.
Change from baseline at 3 months
Modified Thomas Test
Time Frame: Change from baseline at 3 months
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.
Change from baseline at 3 months
Sit-Reach Test
Time Frame: Change from baseline at 3 months
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.
Change from baseline at 3 months
Popliteal Angle
Time Frame: Change from baseline at 3 months
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.
Change from baseline at 3 months
Quality of Life
Time Frame: Change from baseline at 3 months
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.
Change from baseline at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Yildirim Beyazıt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 27, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-235/30

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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