Fibromyalgia SyndromeNCT06791954
The Efficacy of a Telerehabilitation Pilates Program in Fibromyalgia Syndrome Patients
A study testing Exercise in people with Fibromyalgia Syndrome, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
The study aims to evaluate the effects of a telerehabilitation-based clinical pilates program in patients with fibromyalgia syndrome. A randomized controlled trial was designed. An online clinical Pilates-based exercise program targeting stability and strength that was conducted for 8 weeks with 2 sessions per week… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2024to 20 Nov 2024
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of FMS at least one year before the study
- Stable general health condition for the past 6 months
Who cannot join
- Inability to cooperate with measurements
- Regular engagement in exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of a Telerehabilitation Pilates Program on Lumbopelvic Muscle Morphology in Patients With Fibromyalgia Syndrome
The study aims to evaluate the effects of a telerehabilitation-based clinical pilates program in patients with fibromyalgia syndrome. A randomized controlled trial was designed. An online clinical Pilates-based exercise program targeting stability and strength that was conducted for 8 weeks with 2 sessions per week was developed for the telerehabilitation group. The same exercise programs for the control group were provided in brochures.
- Conditions
- Fibromyalgia Syndrome
- Being tested
- Exercise
- Keywords
- Fibromyalgia, Pain, Telehealth, Telemedicine
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Clinical pilates program
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation group | Active comparator | Telerehabilitation group Receives: Other: Exercise |
| Control group | Other | Control group Receives: Other: Exercise |
| Healthy Control Group | No intervention | The first results were compared |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic assessment
A 9 MHz linear probe was utilized to determine the transversus abdominis, external oblique, and internal oblique muscles. For the ultrasonographic evaluation of the lumbar multifidus muscles, subjects were positioned in supine and prone positions. A 1.5-6 MHz convex probe was initially placed in a transverse orientation to cover the L4-L5-S1 anatomical region.
Measured: First day (at beginning) and last day (8. weeks)
McGill core endurance tests
The lumbopelvic stability was conducted using McGill core endurance tests, which included tests for trunk flexion, extension, and right and left lateral flexion endurance.
Measured: First day (at beginning) and last day (8. weeks)
Fibromyalgia Impact Questionnaire
The Fibromyalgia Impact Questionnaire (FIQ) is a measure consisting of 10 items that assess physical function, work status, productivity level, depression, anxiety, sleep, pain, stiffness, fatigue, and overall well-being. Higher scores indicate higher disease activity.
Measured: First day (at beginning) and last day (8. weeks)
Fatigue Severity Scale
Fatigue Severity Scale (FSS) consists of a total of nine items. Each item is scored on a scale from 1 to 7. An increase in the total score indicates a higher level of fatigue severity.
Measured: First day (at beginning) and last day (8. weeks)
Central Sensitization Inventory Short-Form
Central Sensitization Inventory Short Form (CSI-SF) is designed to assess the presence of central sensitization and associated symptoms. The total score ranges from 0 to 36, with higher scores indicating greater severity of central sensitization.
Measured: First day (at beginning) and last day (8. weeks)
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale comprises 14 items. Odd-numbered items assess anxiety, while even-numbered items evaluate depression. The lowest possible score for each subscale is 0, and the highest is 21.
Measured: First day (at beginning) and last day (8. weeks)
Numeric Rating Scale
The Pain Numeric Rating Scale is a numerical version of the visual analog scale, where patients are asked to indicate the number that best reflects their pain severity on a scale from 0 to 10.
Measured: First day (at beginning) and last day (8. weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start15 Jun 2024
- Primary completion15 Aug 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YASEMİN MİRZA, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791954
- Sponsor's protocol ID
- 2024/5012
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Telerehabilitation Pilates Program on Lumbopelvic Muscle Morphology in Patients With Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT06791954
- Acronym / sponsor ID
- 2024/5012
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Fibromyalgia, Pain, Telehealth, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 24 Jan 2025 (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 study aims to evaluate the effects of a telerehabilitation-based clinical pilates program in patients with fibromyalgia syndrome. A randomized controlled trial was designed. An online clinical Pilates-based exercise program targeting stability and strength that was conducted for 8 weeks with 2 sessions per week was developed for the telerehabilitation group. The same exercise programs for the control group were provided in brochures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation group | Active comparator | Other: ExerciseTelerehabilitation group |
| Control group | Other | Other: ExerciseControl group |
| Healthy Control Group | No intervention | –The first results were compared |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of FMS at least one year before the study
- Stable general health condition for the past 6 months
Key exclusion criteria (2 listed)
- Inability to cooperate with measurements
- Regular engagement in exercise
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 |
|---|---|---|
| ExerciseClinical pilates program | Other | Control group, Telerehabilitation group |
Primary outcome
Ultrasonographic assessment
Time frame: First day (at beginning) and last day (8. weeks)
A 9 MHz linear probe was utilized to determine the transversus abdominis, external oblique, and internal oblique muscles. For the ultrasonographic evaluation of the lumbar multifidus muscles, subjects were positioned in supine and prone positions. A 1.5-6 MHz convex probe was initially placed in a transverse orientation to cover the L4-L5-S1 anatomical region.
McGill core endurance tests
Time frame: First day (at beginning) and last day (8. weeks)
The lumbopelvic stability was conducted using McGill core endurance tests, which included tests for trunk flexion, extension, and right and left lateral flexion endurance.
Fibromyalgia Impact Questionnaire
Time frame: First day (at beginning) and last day (8. weeks)
The Fibromyalgia Impact Questionnaire (FIQ) is a measure consisting of 10 items that assess physical function, work status, productivity level, depression, anxiety, sleep, pain, stiffness, fatigue, and overall well-being. Higher scores indicate higher disease activity.
Fatigue Severity Scale
Time frame: First day (at beginning) and last day (8. weeks)
Fatigue Severity Scale (FSS) consists of a total of nine items. Each item is scored on a scale from 1 to 7. An increase in the total score indicates a higher level of fatigue severity.
Central Sensitization Inventory Short-Form
Time frame: First day (at beginning) and last day (8. weeks)
Central Sensitization Inventory Short Form (CSI-SF) is designed to assess the presence of central sensitization and associated symptoms. The total score ranges from 0 to 36, with higher scores indicating greater severity of central sensitization.
Hospital Anxiety and Depression Scale
Time frame: First day (at beginning) and last day (8. weeks)
The Hospital Anxiety and Depression Scale comprises 14 items. Odd-numbered items assess anxiety, while even-numbered items evaluate depression. The lowest possible score for each subscale is 0, and the highest is 21.
Numeric Rating Scale
Time frame: First day (at beginning) and last day (8. weeks)
The Pain Numeric Rating Scale is a numerical version of the visual analog scale, where patients are asked to indicate the number that best reflects their pain severity on a scale from 0 to 10.
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 24 Jan 2025.
- 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 Exercise in people with Fibromyalgia Syndrome, run by Necmettin Erbakan 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 2 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 24 Jan 2025. 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?
Ultrasonographic assessment (time frame: First day (at beginning) and last day (8. weeks)). The study lists 7 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 24 Jan 2025.