Bariatric SurgeryNCT04932694
Optimizing Function Outcomes After Bariatric Surgery With Core Stabilization Training: A Randomized Controlled Study
A study testing Core stabilization training in people with Bariatric Surgery and Surgery, run by Cairo University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Bariatric Surgery, Surgery
- What is being tested?
- Core stabilization training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Jun 2021to 24 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both male and female
- age ranged from 18-25 years old,
- at least 6 months after BS
Who cannot join
- Patients with nerve root compression
- spine disorders
- spinal fracture
- previous spinal surgery
- pregnancy
- lower limb injury
- Any contraindication to the exercise therapy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read the detailed description
This study will investigate the effect of core stabilization exercise on patients who underwent bariatric suergery.
- Conditions
- Bariatric Surgery, Surgery
- Being tested
- Core stabilization training
- Keywords
- Bariatric surgery, Core training, Stabilization exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stabilization trainingOther
Also called Exercises
Exercise training will be given to the participants in the study group in the form of core training exercises for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Core stabilization exercises will be conducted for 8 weeks, 3 sessions per day at home, and exercises will be supervised remotly. Receives: Other: Core stabilization training |
| Control group | No intervention | No exercise will be given to the participants in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core endurance tests
These tests consisted of four positions and calculated the time spent during the test.
Measured: 2 months
Flexor extensor isokinetic torque
These tests consist of flexor and extensor isokinetic torque assessment.
Measured: 2 months
Secondary outcomes (4)
Balance assessment
assess the body balance using balance biodex system
Measured: 2 months
6 min walking test
Assess aerobic capacity and endurance by measuring the distance covered in 6 minutes
Measured: 2 months
Function Assessment
Assess function disability using Oswestry disability index questionnaire.
Measured: 2 months
Trunk sense of position
Assess position sense of the trunk
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start21 Jun 2021
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Batterjee Medical College, Taif University
- Responsible party
- Principal investigator, Olfat Ibrahim Ali, Cairo University
- Investigators
- Olfat I Ali, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932694
- Sponsor's protocol ID
- Bariatric Surgery
- Status last verified
- Feb 2023
- First submitted
- 12 Jun 2021
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Function Outcomes After Bariatric Surgery With Core Stabilization Training: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04932694
- Acronym / sponsor ID
- Bariatric Surgery
- Conditions
- Bariatric Surgery, Surgery
- Keywords
- Bariatric surgery, Core training, Stabilization exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Batterjee Medical College, Taif University
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will investigate the effect of core stabilization exercise on patients who underwent bariatric suergery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Core stabilization trainingCore stabilization exercises will be conducted for 8 weeks, 3 sessions per day at home, and exercises will be supervised remotly. |
| Control group | No intervention | –No exercise will be given to the participants in the control group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both male and female
- age ranged from 18-25 years old,
- at least 6 months after BS
Key exclusion criteria (7 listed)
- Patients with nerve root compression
- spine disorders
- spinal fracture
- previous spinal surgery
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core stabilization trainingAlso: ExercisesExercise training will be given to the participants in the study group in the form of core training exercises for 8 weeks. | Other | Study group |
Primary outcome
Core endurance tests
Time frame: 2 months
These tests consisted of four positions and calculated the time spent during the test.
Flexor extensor isokinetic torque
Time frame: 2 months
These tests consist of flexor and extensor isokinetic torque assessment.
4 secondary outcomes
Balance assessment
Time frame: 2 months
6 min walking test
Time frame: 2 months
Function Assessment
Time frame: 2 months
Trunk sense of position
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: No. Participants data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olfat I Ali, PhD principal investigator
Cairo University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stabilization training in people with Bariatric Surgery and Surgery, run by Cairo University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core endurance tests (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.