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

The Effect of Structured Core Stabilization Exercise Program on Functional Capacity, Physical Fitness and Quality of Life in Obese Subjects Awaiting Bariatric Surgery: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Exercise; Bariatric Surgery Candidate; Obese
• Intervention / Treatment: Other: Core-Stabilization Exercise; Other: Counseling of physical activity

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34740
    • Istanbul University-Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Core-Stabilization Exercise	Other: Core-Stabilization Exercise; A program consisting of core stabilization exercises and physical activity counseling accompanied by physiotherapists will be applied to the study group.
EXPERIMENTAL: Counseling of physical activity	Other: Counseling of physical activity; Only physical activity counseling will be given to the subjects in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six Minute Walk Test	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.	Change from baseline to 8 weeks, follow up at two months
Assessment of Core Stabilization	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.	Change from baseline to 8 weeks, follow up at two months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioelectrical Impedance Analysis-obesity score	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.	Change from baseline to 8 weeks, follow up at two months
Biodex Balance System-Fall Risk Test	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.	Change from baseline to 8 weeks, follow up at two months
Obesity Specific Quality of Life Scale	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).	Change from baseline to 8 weeks, follow up at two months

Collaborators and Investigators

• Sponsor: Istanbul University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2019
• Primary Completion (ACTUAL): November 30, 2019
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (ACTUAL): September 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: exercise; bariatric surgery; obese; core stabilization
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 04/07/2019-101631

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No