FibromyalgiaNCT06741488
Fibromyalgia, Exercise Adherence and Barriers
An observational study of Fibromyalgia, run by Konya Beyhekim Training and Research Hospital.
Trial summary
We aimed to investigate adherence to exercise and perceived barriers to exercise in patients with fibromyalgia who were advised to exercise. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jul 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
- Women only
- Adult, Older adult
Study population: physical medicine and rehabilitation outpatient clinic
Who may be able to join
- Being diagnosed with fibromyalgia according to ACR 2016 criteria
- Female
- To be informed about the benefits of exercise, the importance of exercise compliance and to be shown the exercise program in practice and to be given a printed form
Who cannot join
- Having a systemic or mental disease that may prevent exercise
About this study
Official title: Adherence of Women With Fibromyalgia to Home Exercise Programme and Perceived Barriers to Exercise
We aimed to investigate adherence to exercise and perceived barriers to exercise in patients with fibromyalgia who were advised to exercise.
- Conditions
- Fibromyalgia
- Being tested
- no intervention
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
Exercise Adaptation Rating Scale
| Study group | Role | What they receive |
|---|---|---|
| fibromyalgia | No intervention will be made. The questionnaire will assess adherence to exercise and perceived barriers. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise adherence
Exercise Adaptation Rating Scale, Total score ranges from 0-64, with higher scores indicating greater adherence
Measured: one month after the exercise is recommended
perceived barriers to exercise
Benefits/barriers to exercise scale, The score range of the barrier scale is 14-56 and the score range of the benefit scale is 29-116. The sum of all items in the scale gives the total score of the scale and a high total scale score indicates that the individual finds exercise useful.
Measured: one month after the exercise is recommended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Savaş Karpuz, Konya Beyhekim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741488
- Sponsor's protocol ID
- 2024-10-05
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 19 Dec 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 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence of Women With Fibromyalgia to Home Exercise Programme and Perceived Barriers to Exercise
- ClinicalTrials.gov ID
- NCT06741488
- Acronym / sponsor ID
- 2024-10-05
- Conditions
- Fibromyalgia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 19 Dec 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.
We aimed to investigate adherence to exercise and perceived barriers to exercise in patients with fibromyalgia who were advised to exercise.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fibromyalgia | – | Other: no interventionNo intervention will be made. The questionnaire will assess adherence to exercise and perceived barriers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- physical medicine and rehabilitation outpatient clinic
Key inclusion criteria (3 listed)
- Being diagnosed with fibromyalgia according to ACR 2016 criteria
- Female
- To be informed about the benefits of exercise, the importance of exercise compliance and to be shown the exercise program in practice and to be given a printed form
Key exclusion criteria (1 listed)
- Having a systemic or mental disease that may prevent 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 |
|---|---|---|
| no interventionExercise Adaptation Rating Scale | Other | fibromyalgia |
Primary outcome
exercise adherence
Time frame: one month after the exercise is recommended
Exercise Adaptation Rating Scale, Total score ranges from 0-64, with higher scores indicating greater adherence
perceived barriers to exercise
Time frame: one month after the exercise is recommended
Benefits/barriers to exercise scale, The score range of the barrier scale is 14-56 and the score range of the benefit scale is 29-116. The sum of all items in the scale gives the total score of the scale and a high total scale score indicates that the individual finds exercise useful.
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 19 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Konya Beyhekim Training and Research Hospital.
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 1 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 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
exercise adherence (time frame: one month after the exercise is recommended). 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 19 Dec 2024.