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

NCT04099654 | Completed

• 1 other identifier: 04/07/2019-101631
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obese; Exercise; Bariatric Surgery Candidate

Keywords

obese; core stabilization; bariatric surgery; exercise

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Bioelectrical Impedance Analysis-obesity score

  Change from baseline to 8 weeks, follow up at two months

• Biodex Balance System-Fall Risk Test

  Change from baseline to 8 weeks, follow up at two months

• Obesity Specific Quality of Life Scale

  Change from baseline to 8 weeks, follow up at two months

Study Arms (2)

Core-Stabilization Exercise

EXPERIMENTAL

Other: Core-Stabilization Exercise

Counseling of physical activity

EXPERIMENTAL

Other: Counseling of physical activity

Interventions

Core-Stabilization Exercise OTHER

A program consisting of core stabilization exercises and physical activity counseling accompanied by physiotherapists will be applied to the study group.

Core-Stabilization Exercise

Counseling of physical activity OTHER

Only physical activity counseling will be given to the subjects in this group.

Counseling of physical activity

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34740, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist.Prof.Dr.

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: September 23, 2019
• Study Start: September 30, 2019
• Primary Completion: November 30, 2019
• Study Completion: June 30, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)