- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05996692
Evaluation of Adherence of Women With Fibromyalgia to Walking Prescriptions
Evaluation of Adherence of Women With Fibromyalgia to Walking Prescriptions: a Cross-sectional Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey
- Ankara Gaziler Physical Medicine and Rehabilitation Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- be between 18-70 years old
- female gender
- Pharmacological therapy has been recommended in the last 1 year
Exclusion Criteria:
- neurological disease or orthopedic problem presence that may be the reason of functional impairment
- neurological deficit presence
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
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.
|
|
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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through study completion, an average of one month
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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.
|
through study completion, an average of one month
|
|
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).
|
through study completion, an average of one month
|
|
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.
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through study completion, an average of one month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 39
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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