Optimizing Function Outcomes After Bariatric Surgery With Core Stabilization Training: A Randomized Controlled Study

February 9, 2023 updated by: Olfat Ibrahim Ali, Cairo University
Bariatric surgery has been reported to be the most effective treatment option for losing and maintaining body weight and improving comorbidities and mortality associated with morbid obesity. Nevertheless, even though physical activity is recommended to optimize bariatric surgery results. Very little is known, about whether engaging in an exercise program after surgery can provide additional improvement in health outcomes. While to date there are relatively few researches studied the effect of exercise in patients who have undergone bariatric surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will investigate the effect of core stabilization exercise on patients who underwent bariatric suergery.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dokki
      • Giza, Dokki, Egypt, 12611
        • Olfat Ibrahim Ali
  • Saudi Arabia
      • Jeddah, Saudi Arabia, 12611
        • Olfat Ibrahim Ali

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both male and female
  • age ranged from 18-25 years old,
  • at least 6 months after BS

Exclusion Criteria:

  • Patients with nerve root compression
  • spine disorders
  • spinal fracture
  • previous spinal surgery
  • pregnancy
  • lower limb injury
  • Any contraindication to the exercise therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study group
Core stabilization exercises will be conducted for 8 weeks, 3 sessions per day at home, and exercises will be supervised remotly.
Other: Core stabilization training
Exercise training will be given to the participants in the study group in the form of core training exercises for 8 weeks.
Other Names:
  • Exercises
NO_INTERVENTION: Control group
No exercise will be given to the participants in the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Core endurance tests
Time Frame: 2 months
These tests consisted of four positions and calculated the time spent during the test.
2 months
Flexor extensor isokinetic torque
Time Frame: 2 months
These tests consist of flexor and extensor isokinetic torque assessment.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance assessment
Time Frame: 2 months
assess the body balance using balance biodex system
2 months
6 min walking test
Time Frame: 2 months
Assess aerobic capacity and endurance by measuring the distance covered in 6 minutes
2 months
Function Assessment
Time Frame: 2 months
Assess function disability using Oswestry disability index questionnaire.
2 months
Trunk sense of position
Time Frame: 2 months
Assess position sense of the trunk
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Collaborators

Batterjee Medical College
Taif University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 21, 2021

Primary Completion (ACTUAL)

November 24, 2021

Study Completion (ACTUAL)

November 24, 2021

Study Registration Dates

First Submitted

June 12, 2021

First Submitted That Met QC Criteria

June 18, 2021

First Posted (ACTUAL)

June 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Bariatric Surgery

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participants data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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