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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05996692
Other study ID # 39
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date June 1, 2023

Study information

Verified date August 2023
Source Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Evaluation of adherence to walking prescriptions
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.

Locations

Country Name City State
Turkey Ankara Gaziler Physical Medicine and Rehabilitation Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. through study completion, an average of one month
Primary 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. through study completion, an average of one month
Primary 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). through study completion, an average of one month
Primary 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. through study completion, an average of one month
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