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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05358288
Other study ID # 2018-235/30
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2016
Est. completion date May 27, 2019

Study information

Verified date June 2023
Source Ankara Yildirim Beyazit University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 27, 2019
Est. primary completion date May 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ankara Yildirim Beyazit University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from baseline at 3 months
Secondary 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. Change from baseline at 3 months
Secondary 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. Change from baseline at 3 months
Secondary 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. Change from baseline at 3 months
Secondary 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. Change from baseline at 3 months
Secondary 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. Change from baseline at 3 months
Secondary 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. Change from baseline at 3 months
Secondary 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. Change from baseline at 3 months
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