Evaluation of Adherence of Women With Fibromyalgia to Walking Prescriptions

Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05996692
Collaborator
(none)
100
1
15
6.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Evaluation of adherence to walking prescriptions

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

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Adherence of Women With Fibromyalgia to Walking Prescriptions: a Cross-sectional Study
Actual Study Start Date :
Mar 1, 2022
Actual Primary Completion Date :
Jun 1, 2023
Actual Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm 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.

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.

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Fibromyalgia Impact Questionnaire (FIQ) [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.

  2. The Tampa Scale for Kinesiophobia [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.

  3. Visual Analogue Scale [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).

  4. Pain Catastrophizing Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara Gaziler Physical Medicine and Rehabilitation Hospital Ankara Turkey

Sponsors and Collaborators

  • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yasin Demir, Associate professor, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT05996692
Other Study ID Numbers:
  • 39
First Posted:
Aug 18, 2023
Last Update Posted:
Aug 18, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yasin Demir, Associate professor, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2023