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

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: Completed
• Conditions: Obesity; Gait; Bariatric Surgery

• Study Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): May 30, 2017
• Study Completion (Actual): May 27, 2019

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID 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