FibromyalgiaNCT05996692
Evaluation of Adherence of Women With Fibromyalgia to Walking Prescriptions
An observational study of Fibromyalgia, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Although there are many studies evaluating adherence to supervised walking programs in patients with fibromyalgia (FM), there are limited studies evaluating adherence to unsupervised walking programs. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Evaluation of adherence to walking prescriptions
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 1 Jun 2023
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with FM according to the criteria of the American College of Rheumatology (ACR) and recommended pharmacological therapy within the last 1 year
Who may be able to join
- be between 18-70 years old
- female gender
- Pharmacological therapy has been recommended in the last 1 year
Who cannot join
- neurological disease or orthopedic problem presence that may be the reason of functional impairment
- neurological deficit presence
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Gaziler Physical Medicine and Rehabilitation Hospital
Ankara
About this study
Official title: Evaluation of Adherence of Women With Fibromyalgia to Walking Prescriptions: a Cross-sectional Study
Although there are many studies evaluating adherence to supervised walking programs in patients with fibromyalgia (FM), there are limited studies evaluating adherence to unsupervised walking programs.
Read the detailed description
Although there are many studies evaluating adherence to supervised walking programs in patients with fibromyalgia (FM), there are limited studies evaluating adherence to unsupervised walking programs.
Purposes of this study were (1) to assess whether walking as exercise was prescribed by their physiatrist in Turkish women with FM who received pharmacological therapy, (2) to illustrate the frequency of patients who walk regularly as exercise, (3) to clinically compare patients who walk regularly as exercise and those who do not, and (4) to determine factors related to adherence to walking prescriptions.
- Conditions
- Fibromyalgia
- Being tested
- Evaluation of adherence to walking prescriptions
- Keywords
- Fibromyalgia, Walking, Adherence
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of adherence to walking prescriptionsOther
Adherence to walking prescriptions was evaluated according to a specific criterion (walking at least 30 min, in bouts of 15 min, with a small rest between bouts, twice a week, over a minimum of six consecutive weeks) based on previous recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Patients who walked regularly for exercise | Walking for exercise was explored according to a specific criterion (walking at least 30 min, in bouts of 15 min, with a small rest between bouts, twice a week, over a minimum of six consecutive weeks) based on previous recommendations.
According to this criterion, the patients were divided into 2 groups as those who walked regularly for exercise and those who did not walk regularly for exercise. Receives: Other: Evaluation of adherence to walking prescriptions | |
| Patients who did not walk regularly for exercise | Walking for exercise was explored according to a specific criterion (walking at least 30 min, in bouts of 15 min, with a small rest between bouts, twice a week, over a minimum of six consecutive weeks) based on previous recommendations.
According to this criterion, the patients were divided into 2 groups as those who walked regularly for exercise and those who did not walk regularly for exercise. Receives: Other: Evaluation of adherence to walking prescriptions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire (FIQ)
Fibromyalgia Impact Questionnaire is a survey developed to measure functional status in FM patients. This scale measures 10 separate aspects, namely physical impairment, feel good, work missed, do job, pain, fatigue, rested, stiffness, anxiety, and depression. The total score in the questionnaire is between 0 and 100. Higher scores demonstrate higher disease severity and lower functional status.
Measured: through study completion, an average of one month
The Tampa Scale for Kinesiophobia
The Tampa Scale for Kinesiophobia is a reliable survey on fear of movement. In the survey consisting of 17 questions, the total score is between 17 and 68, with higher scores indicating higher kinesiophobia.
Measured: through study completion, an average of one month
Visual Analogue Scale
Overall pain intensity over the last 7 days was assessed with a Visual Analogue Scale (0 = no pain and 10 = the worst pain you can imagine).
Measured: through study completion, an average of one month
Pain Catastrophizing Scale
Pain Catastrophizing Scale is made up of 13 items scored on a 5-point Likert scale from 0 (never) to 4 (always). The total score is obtained with the sum of the answers, being able to obtain a maximum score of 52. Higher scores in the scale represent a higher tendency to catastrophize.
Measured: through study completion, an average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Mar 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
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-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996692
- Sponsor's protocol ID
- 39
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2023
- Last updated
- 18 Aug 2023
- 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 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adherence of Women With Fibromyalgia to Walking Prescriptions: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05996692
- Acronym / sponsor ID
- 39
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Walking, Adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 18 Aug 2023 (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.
Although there are many studies evaluating adherence to supervised walking programs in patients with fibromyalgia (FM), there are limited studies evaluating adherence to unsupervised walking programs.
Detailed description
Although there are many studies evaluating adherence to supervised walking programs in patients with fibromyalgia (FM), there are limited studies evaluating adherence to unsupervised walking programs.
Purposes of this study were (1) to assess whether walking as exercise was prescribed by their physiatrist in Turkish women with FM who received pharmacological therapy, (2) to illustrate the frequency of patients who walk regularly as exercise, (3) to clinically compare patients who walk regularly as exercise and those who do not, and (4) to determine factors related to adherence to walking prescriptions.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who walked regularly for exercise | – | Other: Evaluation of adherence to walking prescriptionsWalking for exercise was explored according to a specific criterion (walking at least 30 min, in bouts of 15 min, with a small rest between bouts, twice a week, over a minimum of six consecutive weeks) based on previous recommendations. According to this criterion, the patients were divided into 2 groups as those who walked regularly for exercise and those who did not walk regularly for exercise. |
| Patients who did not walk regularly for exercise | – | Other: Evaluation of adherence to walking prescriptionsWalking for exercise was explored according to a specific criterion (walking at least 30 min, in bouts of 15 min, with a small rest between bouts, twice a week, over a minimum of six consecutive weeks) based on previous recommendations. According to this criterion, the patients were divided into 2 groups as those who walked regularly for exercise and those who did not walk regularly for exercise. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with FM according to the criteria of the American College of Rheumatology (ACR) and recommended pharmacological therapy within the last 1 year
Key inclusion criteria (3 listed)
- be between 18-70 years old
- female gender
- Pharmacological therapy has been recommended in the last 1 year
Key exclusion criteria (2 listed)
- neurological disease or orthopedic problem presence that may be the reason of functional impairment
- neurological deficit presence
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 |
|---|---|---|
| Evaluation of adherence to walking prescriptionsAdherence to walking prescriptions was evaluated according to a specific criterion (walking at least 30 min, in bouts of 15 min, with a small rest between bouts, twice a week, over a minimum of six consecutive weeks) based on previous recommendations. | Other | Patients who did not walk regularly for exercise, Patients who walked regularly for exercise |
Primary outcome
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: through study completion, an average of one month
Fibromyalgia Impact Questionnaire is a survey developed to measure functional status in FM patients. This scale measures 10 separate aspects, namely physical impairment, feel good, work missed, do job, pain, fatigue, rested, stiffness, anxiety, and depression. The total score in the questionnaire is between 0 and 100. Higher scores demonstrate higher disease severity and lower functional status.
The Tampa Scale for Kinesiophobia
Time frame: through study completion, an average of one month
The Tampa Scale for Kinesiophobia is a reliable survey on fear of movement. In the survey consisting of 17 questions, the total score is between 17 and 68, with higher scores indicating higher kinesiophobia.
Visual Analogue Scale
Time frame: through study completion, an average of one month
Overall pain intensity over the last 7 days was assessed with a Visual Analogue Scale (0 = no pain and 10 = the worst pain you can imagine).
Pain Catastrophizing Scale
Time frame: through study completion, an average of one month
Pain Catastrophizing Scale is made up of 13 items scored on a 5-point Likert scale from 0 (never) to 4 (always). The total score is obtained with the sum of the answers, being able to obtain a maximum score of 52. Higher scores in the scale represent a higher tendency to catastrophize.
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 18 Aug 2023.
- 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?
An observational study of Fibromyalgia, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital 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 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 18 Aug 2023. 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?
Fibromyalgia Impact Questionnaire (FIQ) (time frame: through study completion, an average of one month). 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 18 Aug 2023.