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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099654
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Saime Nilay Arman, 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.

Condition or disease Intervention/treatment Phase
Obese Exercise Bariatric Surgery Candidate Other: Core-Stabilization Exercise Other: Counseling of physical activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : September 30, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Six Minute Walk Test [ Time Frame: 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.

  2. Assessment of Core Stabilization [ Time Frame: 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.


Secondary Outcome Measures :
  1. Bioelectrical Impedance Analysis-obesity score [ Time Frame: 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.

  2. Biodex Balance System-Fall Risk Test [ Time Frame: 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.

  3. Obesity Specific Quality of Life Scale [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099654


Contacts
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Contact: Nilay Arman, Assist.Prof.Dr. 905534558707 saimenilayarman@istanbul.edu.tr
Contact: Gulfidan Tokgoz 905415013570 gul.tokgozbrk@hotmail.com

Sponsors and Collaborators
Istanbul University
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Responsible Party: Saime Nilay Arman, Assist.Prof.Dr., Istanbul University
ClinicalTrials.gov Identifier: NCT04099654    
Other Study ID Numbers: 04/07/2019-101631
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Saime Nilay Arman, Istanbul University:
obese
core stabilization
bariatric surgery
exercise
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms