Fibromyalgia SyndromeNCT06678932
Arm Exercise Capacity, Muscle Strength and Activities of Daily Living in Patients with Fibromyalgia Syndrome
An observational study of Fibromyalgia Syndrome, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the upper extremity exercise capacity, muscle strength and activities of daily living of patients with fibromyalgia syndrome and healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia Syndrome
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2024to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with fibromyalgia syndrome and healthy individuals will be included in the study.
Who may be able to join
- Being diagnosed with fibromyalgia syndrome
- Being aged 18-65
- Stable use of medication for at least 3 months or longer
- Volunteering to participate in the study
- Being aged 18-65
- Volunteering to participate in the study
Who cannot join
- Having comorbidities that may affect physical functions
- Failure to cooperate with tests to be performed
- Presence of exercise test contraindication
- Having a chronic or systemic disease
- Failure to cooperate with tests to be performed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kirsehir Ahi Evran University
Kırşehir
Merve Firat, +90 850 441 02 44, mervefirat@ahievran.edu.tr
About this study
Official title: Comparison of Arm Exercise Capacity, Muscle Strength and Daily Living Activities of Patients with Fibromyalgia Syndrome and Healthy Controls
The aim of this study is to compare the upper extremity exercise capacity, muscle strength and activities of daily living of patients with fibromyalgia syndrome and healthy individuals.
- Conditions
- Fibromyalgia Syndrome
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia syndrome | Not described | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity exercise capacity
This will be evaluated with arm ergometer test.
Measured: 1st day
Muscle strength
Hand grip strength will be measured using a hand grip dynamometer.
Measured: 1st day
Muscle endurance
30 second push-up test will be used, and total number will be recorded.
Measured: 1st day
Activities of daily living
It will be evaluated with the Glittre Activities of Daily Living test, and total time will be recorded.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (estimated)
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 Kirsehir Ahi Evran UniversitesiThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Firat, Kirsehir Ahi Evran Universitesi
- Investigators
- Basak Kavalci Kol, Study chair, Kirsehir Ahi Evran UniversitesiFigen Tuncay, Study chair, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678932
- Sponsor's protocol ID
- 2024-13/115
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Arm Exercise Capacity, Muscle Strength and Daily Living Activities of Patients with Fibromyalgia Syndrome and Healthy Controls
- ClinicalTrials.gov ID
- NCT06678932
- Acronym / sponsor ID
- 2024-13/115
- Conditions
- Fibromyalgia Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Nov 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 the upper extremity exercise capacity, muscle strength and activities of daily living of patients with fibromyalgia syndrome and healthy individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia syndrome | – | – |
| Healthy controls | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with fibromyalgia syndrome and healthy individuals will be included in the study.
Key inclusion criteria (6 listed)
- Being diagnosed with fibromyalgia syndrome
- Being aged 18-65
- Stable use of medication for at least 3 months or longer
- Volunteering to participate in the study
- Being aged 18-65
Key exclusion criteria (5 listed)
- Having comorbidities that may affect physical functions
- Failure to cooperate with tests to be performed
- Presence of exercise test contraindication
- Having a chronic or systemic disease
- Failure to cooperate with tests to be performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Upper extremity exercise capacity
Time frame: 1st day
This will be evaluated with arm ergometer test.
Muscle strength
Time frame: 1st day
Hand grip strength will be measured using a hand grip dynamometer.
Muscle endurance
Time frame: 1st day
30 second push-up test will be used, and total number will be recorded.
Activities of daily living
Time frame: 1st day
It will be evaluated with the Glittre Activities of Daily Living test, and total time will be recorded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
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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.
Basak Kavalci Kol study chair
Kirsehir Ahi Evran Universitesi
Figen Tuncay study chair
Kirsehir Ahi Evran Universitesi
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 Syndrome, run by Kirsehir Ahi Evran Universitesi 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 7 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merve Firat (+90 850 441 02 44, mervefirat@ahievran.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper extremity exercise capacity (time frame: 1st day). The study lists 4 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 7 Nov 2024.