NCT05996692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

August 10, 2023

Last Update Submit

August 10, 2023

Conditions

Fibromyalgia

Keywords

FibromyalgiaWalkingAdherence

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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

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

Interventions

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.

Patients who did not walk regularly for exercisePatients who walked regularly for exercise

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince most of the patients with fibromyalgia are women, only female patients were included in the study, since a more homogeneous population was targeted.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • be between 18-70 years old
  • female gender
  • Pharmacological therapy has been recommended in the last 1 year

You may not qualify if:

  • neurological disease or orthopedic problem presence that may be the reason of functional impairment
  • neurological deficit presence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Gaziler Physical Medicine and Rehabilitation Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 18, 2023

Study Start

March 1, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)