Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05519436
Other study ID # 2022/242
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date July 31, 2023

Study information

Verified date March 2024
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The fact that changes in plantar pressure during walking and in a fixed position in morbidly obese individuals and the relationship between postural oscillations and balance have not been fully elucidated creates a need in this area. In this study, primary aim is to investigate the change in plantar foot pressure, balance parameters and the relationship between them in morbidly obese individuals compared to healthy individuals.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 31, 2023
Est. primary completion date October 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Individuals between the ages of 18-60 - BMI = 40 kg/m2, morbidly obese individual - No surgical operation in the last 6 months - Non-obese healthy adult individuals will be included in the study as the control group. Exclusion Criteria: - Having a musculoskeletal disorder or systemic disease that will interfere with physical activity - Presence of balance problems that will prevent physical activity - Presence of psychiatric or neurological disease affecting cooperation and cognitive functions - Presence of acute pain - Presence of uncontrolled diabetes and hypertension - Having any communication problems

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Assessment
Bioelectrical impedance analysis method was used to evaluate the body composition of the cases. Muscle, fat, water ratio was made with Inbody Bioelectrical Impedance Device. Static and dynamic plantar pressure analyzes were evaluated with Sensor Medica pedobarographic measuring device, and postural sway was evaluated with "bilateral comparison tests", one of the dynamic balance tests of Biodex Balance System.

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Elrazek AE, Elbanna AE, Bilasy SE. Medical management of patients after bariatric surgery: Principles and guidelines. World J Gastrointest Surg. 2014 Nov 27;6(11):220-8. doi: 10.4240/wjgs.v6.i11.220. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Static and dynamic plantar pressure analyzes To evaluate the plantar pressure, a computerized pedobarographic measuring device with a pressure sensor platform, which can measure the load on the sole of the foot statically and dynamically, and detect the displacement of the pressure center while standing, was used. 2019-2020
Secondary Bioelectrical Impedance Analysis (BIA) Measurement The muscle, fat, and water ratio of the cases were evaluated with the Inbody Bioelectrical Impedance Device. 2019-2020
Secondary Biodex Balance System Biodex Balance System is a system that provides the opportunity to evaluate the balance statically and dynamically. It allows to measure the displacements in the center of gravity of the patient standing on a standing balance platform and the reactions when the support surface changes. "Bilateral comparison tests", one of the dynamic balance tests of the Biodex balance System, were used to evaluate the postural sway of the cases. 2019-2020
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04517591 - Reducing Sedentary Time in Bariatric: The Take a STAND for Health Study N/A
Active, not recruiting NCT04583683 - Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities N/A
Completed NCT01550601 - Impact of the Preservation of the Gastric Antrum in the Technique of Sleeve Gastrectomy for the Treatment of the Morbid Obesity N/A
Completed NCT03638843 - Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2 N/A
Recruiting NCT05917795 - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates N/A
Completed NCT03339791 - Sleeve Versus Bypass in Older Patients: a Randomized Controlled Trial N/A
Recruiting NCT05711758 - Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure
Not yet recruiting NCT04209842 - Effectiveness Gastric Balloon in Obese Adolescents N/A
Recruiting NCT03100292 - Korean OBEsity Surgical Treatment Study N/A
Active, not recruiting NCT04357119 - Common Limb Length in One-anastomosis Gastric Bypass N/A
Completed NCT03210207 - Gastric Plication in Mexican Patients N/A
Completed NCT02590406 - EPO2-A: Evaluation of Pre-Oxygenation in Morbid Obesity: Effect of Position and Positive Pressure Ventilation N/A
Completed NCT01840020 - BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery
Completed NCT01183975 - Swedish Adjustable Gastric Banding Observational Cohort Study N/A
Completed NCT03872024 - Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients N/A
Terminated NCT05993169 - Body Composition Optimization Intervention RCT N/A
Not yet recruiting NCT05974995 - Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer N/A
Recruiting NCT05554016 - The UFO (Ultra Processed Foods in Obesity) Project
Completed NCT05519423 - Investigation of the Effectiveness of Whatsapp-Based Physical Activity Incentive Program in Morbidly Obese Individuals N/A
Not yet recruiting NCT05499949 - The Franciscus Obesity NASH Study