The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery

Not Applicable

Completed

• Conditions: Bariatric Surgery Candidate; Obese; Exercise
• Interventions: Other: Core-Stabilization Exercise; Other: Counseling of physical activity

• Registration Number: NCT04099654
• Lead Sponsor: Istanbul University

Brief Summary

In this study, our primary aim is to investigate the effects of structured core stabilization exercise program on functional capacity, body composition, muscle strength, endurance, balance, quality of life in adult obese individuals expecting bariatric surgery. Our secondary aim is to provide the individual with exercise habits and increase the level of physical activity in daily life with the exercise program planned according to the needs of the individual.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-23
• Study Start: 2019-09-30
• Primary Completion: 2019-11-30
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Individuals aged between 18-65
• BMI ≥30 kg/m2, individuals waiting bariatric surgery
• No surgical operation in the last 6 months

Exclusion Criteria

• Musculoskeletal disorders or systemic diseases that may prevent exercise
• The presence of psychiatric or neurological disease affecting cooperation and cognitive functions
• Presence of acute pain
• Heart pain
• Presence of previous myocardial infarction, subjective heart failure, uncontrolled diabetes and hypertension
• Regular exercise for 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Core-Stabilization Exercise	Core-Stabilization Exercise	-
Counseling of physical activity	Counseling of physical activity	-

Primary Outcome Measures

Name	Time	Method
Assessment of Core Stabilization	Change from baseline to 8 weeks, follow up at two months	Core stabilization evaluation will be done with Anterior and Side Abdominal Strength Tests, Trunk Flexor Test and Modified Push Up Test. These tests will be performed using a 2 kilogram medicine ball. Test positions are supine and sitting position.
Six Minute Walk Test	Change from baseline to 8 weeks, follow up at two months	The Six Minute Walk Test was conducted according to a standardized protocol, using an internal hallway with the 30-meter distance marked by colored tape on the floor. Participants will be told that "the purpose of this test is to see how far you can walk in six minutes." Then, they will be instructed to "walk from end to end of the hallway at your own pace, in order to cover as much ground as possible." Participants will be allowed to stop and rest during the test, but will be instructed to resume walking as soon as they were able to do so. Before the walk started and at the end of the 6-min walk, participants will be shown a modified Borg dyspnea scale printed on a card and asked to "indicate your current degree of shortness of breath" on a scale of "0 = nothing at all" to "10 = very, very severe." At the end of the walk, they will be asked if they had experienced any of the following specific symptoms: dyspnea, chest pain, light-headedness, or leg pain, or any other symptoms.

Secondary Outcome Measures

Name	Time	Method
Bioelectrical Impedance Analysis-obesity score	Change from baseline to 8 weeks, follow up at two months	Body components such as body fat percentage, body fat amount, lean body percentage, lean body mass, body water percentage, body water quantity, body mass index are calculated with bioelectrical impedance analysis. The muscle, fat and water ratio of the cases will be evaluated with Tanita Bioelectric Impedance Device. When the device assess the body fat percentage, body fat amount, lean body percentage, lean body mass, body water percentage, body water quantity and body mass index, it offers to us a score as called obesity score.
Biodex Balance System-Fall Risk Test	Change from baseline to 8 weeks, follow up at two months	Biodex Balance System is a system that offers the possibility of evaluating the balance statically and dynamically. It is a system that measures the displacements in the center of gravity of a patient standing on an outpatient balance platform and the reactions of the support surface when the surface changes. For the static balance will be assessed with "Fall Risk Test " by using Biodex Balance system. Fall risk test offers to us a total score.
Obesity Specific Quality of Life Scale	Change from baseline to 8 weeks, follow up at two months	Quality of life (QoL) will be measured using the Obesity Specific Quality Of Life (OSQOL) questionnaire. This disease-specific questionnaire includes 11 questions grouped into four dimensions: 1- "Physical state" (7 questions), 2- "Vitality, desire to do things" (2 questions), 3- "Relations with other people" (1 question), 4- "Psychological state" (1 question). Each question offered five possible answers ('absolutely false', 'fairly false', 'neither true nor false', 'fairly true' and 'absolutely true'), classified according to reduced QoL. For dimensions 1 and 2, a quantitative score is calculated (0% minimal QoL, 100% maximal QoL).

Trial Locations

Locations (1)

Istanbul University-Cerrahpasa; 🇹🇷 Istanbul, Turkey