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

Sponsor

Ankara Yildirim Beyazıt University (Other)

Overall Status

Completed

CT.gov ID

NCT05358288

Collaborator

(none)

Enrollment

31.8

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Bariatric Surgery Gait

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Investigation of the Effect of Bariatric Surgery on Physical Activity Levels, Spatiotemporal Parameters of Gait, Flexibility and Quality of Life

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

May 30, 2017

Actual Study Completion Date :

May 27, 2019

Outcome Measures

Primary Outcome Measures

Gait speed [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.

Secondary Outcome Measures

Support times [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.
Step Length [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.
Levels of physical activity [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.
Sit-Reach Test [Change from baseline at 3 months]
Flexibility of the lumbar extensors, hamstrings and gastrosoleus muscle group was evaluated with the Sit-Reach Test. Individuals were asked to come to a long sitting position, sit with feet in 90 degrees dorsiflexion and to reach out to toes with hands without bending knees. The test was repeated three times and the maximum value between these values was recorded in centimeters. If this value is behind the toes, negative, if it reaches beyond, positive values were used. Higher positive values indicate better flexibility.
Modified Thomas Test [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.
Popliteal Angle [Change from baseline at 3 months]
Hamstring shortness was determined by popliteal angle measurement. While the participant was supine, the goniometer was zeroed on the anterior-lower half of the tibia and the hip was stabilized at 90 degrees of flexion. The popliteal angle was determined by measuring the maximum range of motion of the knee. The average of two measurements made five seconds apart was recorded. If the popliteal angle measurement was above 20 degrees, it was considered as hamstring shortness.
Quality of Life [Change from baseline at 3 months]
Participants' quality of life were evaluated The Impact of Weight on Quality of Life Questionnaire (IWQOL). The scale includes bodily functions (11 items), self-confidence (7 substance), sexual life (4 items), social pressure (5 items), and work (4 items). It consists of 5 subgroups and a total of 31 items. The minimum score that can be obtained from the scale is 0, and the maximum score is 100. According to the scoring obtained from the scale; As the score decreases, the quality of life decreases, and as the score increases, the quality of life increases.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ankara Yildirim Beyazıt University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ankara Yildirim Beyazıt University

ClinicalTrials.gov Identifier:

NCT05358288

Other Study ID Numbers:

2018-235/30

First Posted:

May 3, 2022

Last Update Posted:

May 3, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 3, 2022