FibromyalgiaNCT06604936
Investigation of Core Endurance in Fibromyalgia
An observational study of Fibromyalgia, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare core endurance and balance in patients with Fibromyalgia Syndrome (FMS) with healthy subjects and to evaluate the relationship between core endurance and balance.The study will include 44 FMS patients and 44 age- and sex-matched healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Fibromyalgia group and Healthy group
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Sep 2024to 20 Oct 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients aged 18-65 years, diagnosed with FMS by clinical and physical examination, who agreed to participate in the study were included in the study. Patients with a diagnosis of severe spinal stenosis, concomitant systemic inflammatory rheumatic disease, pregnancy, malignancy or infection, history of surgery in the last 3 months, and physical problems that would prevent the application of core endurance tests were excluded.
Who may be able to join
- Patients who were aged between 18-65 years,
- Patients who got diagnosed with Fibromyalgia Syndrome
Who cannot join
- Patients who had regular exercise habits, malignancy, pregnancy, incorporation
- Patients who had changes of medical treatment in last 3 months
- Patients who had dysfunction that can prevent physical activity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Songul Baglan Yentur
Elâzığ, 23100
Songul Baglan Yentur, 04242370000, songulbaglan23@hotmail.com
Songul Baglan Yentur, +904242370000, songulbaglan23@hotmail.com
About this study
Official title: Investigation of Balance and Core Endurance in Patients With Fibromyalgia Syndrome
The aim of this study is to compare core endurance and balance in patients with Fibromyalgia Syndrome (FMS) with healthy subjects and to evaluate the relationship between core endurance and balance.The study will include 44 FMS patients and 44 age- and sex-matched healthy controls. Demographic data of the participants will be recorded. Then, core endurance will be assessed with McGill core endurance tests, balance will be evaluated with HUR BTG4 Balance Master System and Berg Balance Scale (BBS), and function will be assessed with Fibromyalgia Impact Questionnaire (FIQ).
Read the detailed description
Fibromyalgia Syndrome (FMS) is defined as a chronic disease with an unclear etiology, which is characterized by widespread musculoskeletal pain, mainly non-inflammatory, in females between 40-60 years of age, accompanied by fatigue, weakness, sleep problems, depression, anxiety and various cognitive and somatic disorders. The etiology and pathophysiology are still unclear. Balance is a key component of activities of daily living such as walking, running and climbing stairs. Maintaining an upright posture is a complex process that involves perceiving and integrating sensory inputs, planning movements, and executing them effectively. It is also defined as the ability to control the center of gravity within the base of support. The aim of this study is to compare core endurance and balance in patients with Fibromyalgia Syndrome (FMS) with healthy subjects and to evaluate the relationship between core endurance and balance.The study will include 44 FMS patients and 44 age- and sex-matched healthy controls. Demographic data of the participants will be recorded. Then, core endurance will be assessed with McGill core endurance tests, balance will be evaluated with HUR BTG4 Balance Master System and Berg Balance Scale (BBS), and function will be assessed with Fibromyalgia Impact Questionnaire (FIQ).
- Conditions
- Fibromyalgia
- Being tested
- Fibromyalgia group, Healthy group
- Keywords
- Fibromyalgia, core endurance test, balance
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibromyalgia groupOther
Demographic information (age, height, weight, occupation, medication, smoking) of the individuals who agreed to participate in the study will be recorded. Then, static and dynamic core endurance tests will be performed to evaluate core endurance. Static core endurance tests will include side bridge test, trunk flexion test, trunk extension test and prone bridge test. Modified push-ups and sit-ups tests will be performed as dynamic core endurance tests. Functional status of the patients will be evaluated with the Fibromyalgia Impact Questionnaire. Static and dynamic balance assessment will be evaluated using the HUR BTG4 Balance Master System and Berg Balance Scale.
Healthy groupOther
Demographic information (age, height, weight, occupation, medication, smoking) of the individuals who agreed to participate in the study will be recorded. Then, static and dynamic core endurance tests will be performed to evaluate core endurance. Static core endurance tests will include side bridge test, trunk flexion test, trunk extension test and prone bridge test. Modified push-ups and sit-ups tests will be performed as dynamic core endurance tests. Static and dynamic balance assessment will be evaluated using the HUR BTG4 Balance Master System and Berg Balance Scale.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia group | Demographic information (age, height, weight, occupation, medication, smoking) of the individuals who agreed to participate in the study will be recorded. Then, static and dynamic core endurance tests will be performed to evaluate core endurance. Static core endurance tests will include side bridge test, trunk flexion test, trunk extension test and prone bridge test. Modified push-ups and sit-ups tests will be performed as dynamic core endurance tests. Functional status of the patients will be evaluated with the Fibromyalgia Impact Questionnaire. Static and dynamic balance assessment will be evaluated using the HUR BTG4 Balance Master System and Berg Balance Scale. Receives: Other: Fibromyalgia group | |
| Healthy group | individuals who agreed to participate in the study will be recorded. Then, static and dynamic core endurance tests will be performed to evaluate core endurance. Static core endurance tests will include side bridge test, trunk flexion test, trunk extension test and prone bridge test. Modified push-ups and sit-ups tests will be performed as dynamic core endurance tests. Static and dynamic balance assessment will be evaluated using the HUR BTG4 Balance Master System and Berg Balance Scale. Receives: Other: Healthy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side bridge test
Participants will be asked to lift their hips off the floor in a side lying position with support from the elbow and forearm. After the patients will place their whole body in a straight line on their feet and elbows, the time was started to be kept with a stopwatch. The time will be maintained for the right and left side was recorded as a score.
Measured: up to 2 weeks
Trunk flexion test
Participants will be asked to position the upper trunk at 60⁰ flexion while the hips and knees will be in the 90⁰ flexion position. The time the patients could stand while maintaining this angle will be recorded.
Measured: up to 2 weeks
Trunk extension test
Participants will be asked to lie prone out of the bed from the upper part of the iliac crista with their hips and knees in full extension. The time will maintain the horizontal position with their arms in the inverted T position will be measured with a stopwatch and recorded
Measured: up to 2 weeks
Secondary outcomes (3)
Balance assessment
Balance will be evaluated with the HUR BTG4 Balance Master System® (HUR International, Finland) on stable and unstable platform.
Measured: up to 2 weeks
Functional assessment
Function will be assessed with the Fibromyalgia Impact Questionnaire (FIQ). The FIQ consists of 10 items. The first item includes daily activity questions scored on a Likert scale from 0 to 3 (always able to do - never able to do). The 10 items are added together to calculate the total score
Measured: up to 2 weeks
Demographic assessment
Age, height, weight, occupation, medication, smoking will be asked and recorded from the patients
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start17 Sep 2024 (estimated)
- Primary completion14 Oct 2024 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songül Bağlan Yentür, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604936
- Sponsor's protocol ID
- 2022/ 11- 24
- Status last verified
- Sep 2024
- First submitted
- 14 Aug 2024
- Last updated
- 20 Sep 2024
- Results posted
- 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 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Balance and Core Endurance in Patients With Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT06604936
- Acronym / sponsor ID
- 2022/ 11- 24
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, core endurance test, balance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 17 Sep 2024 (estimated)
- Primary completion
- 14 Oct 2024 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 20 Sep 2024 (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.
The aim of this study is to compare core endurance and balance in patients with Fibromyalgia Syndrome (FMS) with healthy subjects and to evaluate the relationship between core endurance and balance.The study will include 44 FMS patients and 44 age- and sex-matched healthy controls. Demographic data of the participants will be recorded. Then, core endurance will be assessed with McGill core endurance tests, balance will be evaluated with HUR BTG4 Balance Master System and Berg Balance Scale (BBS), and function will be assessed with Fibromyalgia Impact Questionnaire (FIQ).
Detailed description
Fibromyalgia Syndrome (FMS) is defined as a chronic disease with an unclear etiology, which is characterized by widespread musculoskeletal pain, mainly non-inflammatory, in females between 40-60 years of age, accompanied by fatigue, weakness, sleep problems, depression, anxiety and various cognitive and somatic disorders. The etiology and pathophysiology are still unclear. Balance is a key component of activities of daily living such as walking, running and climbing stairs. Maintaining an upright posture is a complex process that involves perceiving and integrating sensory inputs, planning movements, and executing them effectively. It is also defined as the ability to control the center of gravity within the base of support. The aim of this study is to compare core endurance and balance in patients with Fibromyalgia Syndrome (FMS) with healthy subjects and to evaluate the relationship between core endurance and balance.The study will include 44 FMS patients and 44 age- and sex-matched healthy controls. Demographic data of the participants will be recorded. Then, core endurance will be assessed with McGill core endurance tests, balance will be evaluated with HUR BTG4 Balance Master System and Berg Balance Scale (BBS), and function will be assessed with Fibromyalgia Impact Questionnaire (FIQ).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia group | – | Other: Fibromyalgia groupDemographic information (age, height, weight, occupation, medication, smoking) of the individuals who agreed to participate in the study will be recorded. Then, static and dynamic core endurance tests will be performed to evaluate core endurance. Static core endurance tests will include side bridge test, trunk flexion test, trunk extension test and prone bridge test. Modified push-ups and sit-ups tests will be performed as dynamic core endurance tests. Functional status of the patients will be evaluated with the Fibromyalgia Impact Questionnaire. Static and dynamic balance assessment will be evaluated using the HUR BTG4 Balance Master System and Berg Balance Scale. |
| Healthy group | – | Other: Healthy groupindividuals who agreed to participate in the study will be recorded. Then, static and dynamic core endurance tests will be performed to evaluate core endurance. Static core endurance tests will include side bridge test, trunk flexion test, trunk extension test and prone bridge test. Modified push-ups and sit-ups tests will be performed as dynamic core endurance tests. Static and dynamic balance assessment will be evaluated using the HUR BTG4 Balance Master System and Berg Balance Scale. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-65 years, diagnosed with FMS by clinical and physical examination, who agreed to participate in the study were included in the study. Patients with a diagnosis of severe spinal stenosis, concomitant systemic inflammatory rheumatic disease, pregnancy, malignancy or infection, history of surgery in the last 3 months, and physical problems that would prevent the application of core endurance tests were excluded.
Key inclusion criteria (2 listed)
- Patients who were aged between 18-65 years,
- Patients who got diagnosed with Fibromyalgia Syndrome
Key exclusion criteria (3 listed)
- Patients who had regular exercise habits, malignancy, pregnancy, incorporation
- Patients who had changes of medical treatment in last 3 months
- Patients who had dysfunction that can prevent physical activity
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 |
|---|---|---|
| Fibromyalgia groupDemographic information (age, height, weight, occupation, medication, smoking) of the individuals who agreed to participate in the study will be recorded. Then, static and dynamic core endurance tests will be performed to evaluate core endurance. Static core endurance tests will include side bridge test, trunk flexion test, trunk extension test and prone bridge test. Modified push-ups and sit-ups tests will be performed as dynamic core endurance tests. Functional status of the patients will be evaluated with the Fibromyalgia Impact Questionnaire. Static and dynamic balance assessment will be evaluated using the HUR BTG4 Balance Master System and Berg Balance Scale. | Other | Fibromyalgia group |
| Healthy groupDemographic information (age, height, weight, occupation, medication, smoking) of the individuals who agreed to participate in the study will be recorded. Then, static and dynamic core endurance tests will be performed to evaluate core endurance. Static core endurance tests will include side bridge test, trunk flexion test, trunk extension test and prone bridge test. Modified push-ups and sit-ups tests will be performed as dynamic core endurance tests. Static and dynamic balance assessment will be evaluated using the HUR BTG4 Balance Master System and Berg Balance Scale. | Other | Healthy group |
Primary outcome
Side bridge test
Time frame: up to 2 weeks
Participants will be asked to lift their hips off the floor in a side lying position with support from the elbow and forearm. After the patients will place their whole body in a straight line on their feet and elbows, the time was started to be kept with a stopwatch. The time will be maintained for the right and left side was recorded as a score.
Trunk flexion test
Time frame: up to 2 weeks
Participants will be asked to position the upper trunk at 60⁰ flexion while the hips and knees will be in the 90⁰ flexion position. The time the patients could stand while maintaining this angle will be recorded.
Trunk extension test
Time frame: up to 2 weeks
Participants will be asked to lie prone out of the bed from the upper part of the iliac crista with their hips and knees in full extension. The time will maintain the horizontal position with their arms in the inverted T position will be measured with a stopwatch and recorded
3 secondary outcomes
Balance assessment
Time frame: up to 2 weeks
Functional assessment
Time frame: up to 2 weeks
Demographic assessment
Time frame: up to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Firat 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side bridge test (time frame: up to 2 weeks). The study lists 3 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 20 Sep 2024.