Evaluation of Adherence of Women With Fibromyalgia to Walking Prescriptions

• ClinicalTrials.gov Identifier: NCT05996692
• Recruitment Status: Completed
• First Posted: August 18, 2023
• Last Update Posted: August 18, 2023
• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Information provided by (Responsible Party): Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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
Fibromyalgia	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: March 1, 2022
• Actual Primary Completion Date: June 1, 2023
• Actual Study Completion Date: June 1, 2023

Groups and Cohorts

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.	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) [ 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.
2. 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.
3. 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).
4. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Since most of the patients with fibromyalgia are women, only female patients were included in the study, since a more homogeneous population was targeted.
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

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

Criteria

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

Turkey

Ankara Gaziler Physical Medicine and Rehabilitation Hospital

Ankara, Turkey

Sponsors and Collaborators

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

More Information

• 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: August 18, 2023
• Last Update Posted: August 18, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• 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, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital:

Fibromyalgia; Walking; Adherence

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases