NCT04932694

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

June 21, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2021

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

June 12, 2021

Last Update Submit

February 9, 2023

Conditions

Keywords

Bariatric surgeryCore trainingStabilization exercises

Outcome Measures

Primary Outcomes (2)

  • Core endurance tests

    These tests consisted of four positions and calculated the time spent during the test.

    2 months

  • Flexor extensor isokinetic torque

    These tests consist of flexor and extensor isokinetic torque assessment.

    2 months

Secondary Outcomes (4)

  • Balance assessment

    2 months

  • 6 min walking test

    2 months

  • Function Assessment

    2 months

  • Trunk sense of position

    2 months

Study Arms (2)

Study group

EXPERIMENTAL

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

Control group

NO INTERVENTION

No exercise will be given to the participants in the control group

Interventions

Exercise training will be given to the participants in the study group in the form of core training exercises for 8 weeks.

Also known as: Exercises
Study group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Olfat Ibrahim Ali

Giza, Dokki, 12611, Egypt

Location

Olfat Ibrahim Ali

Jeddah, 12611, Saudi Arabia

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Olfat I Ali, PhD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 12, 2021

First Posted

June 21, 2021

Study Start

June 21, 2021

Primary Completion

November 24, 2021

Study Completion

November 24, 2021

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Participants data will not be shared.

Locations