ObeseNCT04099654
The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery
A study testing Core-Stabilization Exercise and Counseling of physical activity in people with Obese and Exercise, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obese, Exercise, Bariatric Surgery Candidate
- What is being tested?
- Core-Stabilization Exercise and Counseling of physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2019to 30 Jun 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged between 18-65
- BMI ≥30 kg/m2, individuals waiting bariatric surgery
- No surgical operation in the last 6 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34740
About this study
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
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
- Being tested
- Core-Stabilization Exercise, Counseling of physical activity
- Keywords
- obese, core stabilization, bariatric surgery, exercise
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core-Stabilization ExerciseOther
A program consisting of core stabilization exercises and physical activity counseling accompanied by physiotherapists will be applied to the study group.
Counseling of physical activityOther
Only physical activity counseling will be given to the subjects in this group.
| Study group | Role | What they receive |
|---|---|---|
| Core-Stabilization Exercise | Experimental | Not described Receives: Other: Core-Stabilization Exercise |
| Counseling of physical activity | Experimental | Not described Receives: Other: Counseling of physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline to 8 weeks, follow up at two months
Secondary outcomes (3)
Bioelectrical Impedance Analysis-obesity score
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.
Measured: Change from baseline to 8 weeks, follow up at two months
Biodex Balance System-Fall Risk Test
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.
Measured: Change from baseline to 8 weeks, follow up at two months
Obesity Specific Quality of Life Scale
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).
Measured: Change from baseline to 8 weeks, follow up at two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start30 Sep 2019
- Primary completion30 Nov 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saime Nilay Arman, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099654
- Sponsor's protocol ID
- 04/07/2019-101631
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2019
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04099654
- Acronym / sponsor ID
- 04/07/2019-101631
- Conditions
- Obese, Exercise, Bariatric Surgery Candidate
- Keywords
- obese, core stabilization, bariatric surgery, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 23 Sep 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core-Stabilization Exercise | Experimental | Other: Core-Stabilization Exercise |
| Counseling of physical activity | Experimental | Other: Counseling of physical activity |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals aged between 18-65
- BMI ≥30 kg/m2, individuals waiting bariatric surgery
- No surgical operation in the last 6 months
Key exclusion criteria (6 listed)
- 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
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 ExerciseA program consisting of core stabilization exercises and physical activity counseling accompanied by physiotherapists will be applied to the study group. | Other | Core-Stabilization Exercise |
| Counseling of physical activityOnly physical activity counseling will be given to the subjects in this group. | Other | Counseling of physical activity |
Primary outcome
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.
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.
3 secondary outcomes
Bioelectrical Impedance Analysis-obesity score
Time frame: Change from baseline to 8 weeks, follow up at two months
Biodex Balance System-Fall Risk Test
Time frame: Change from baseline to 8 weeks, follow up at two months
Obesity Specific Quality of Life Scale
Time frame: Change from baseline to 8 weeks, follow up at two 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 29 Jul 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core-Stabilization Exercise and Counseling of physical activity in people with Obese and Exercise, run by Istanbul University at 1 site in Turkey (Türkiye).
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 6 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 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Six Minute Walk Test (time frame: Change from baseline to 8 weeks, follow up at two 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 29 Jul 2020.