Fatigue Levels in Fibromyalgia Syndrome

July 11, 2022 updated by: Başak Çiğdem Karaçay, Yerkoy State Hospital

Fatigue Levels in Fibromyalgia Syndrome and the Relationship Between Disease Activity, Kinesiophobia and Physical Activity

Ninety (90) woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria and 90 healthy volunteers were included. The Fibromyalgia Impact Questionnaire (FIQ) is used to assess the patient's functionality and determine the severity of the disease. The Fatigue Severity Scale (FSS) assessed the level and severity of fatigue. The short form of the International Physical Activity Questionnaire (IPAQ-SF) used to asess physical activity levels.The kinesiophobia level was assessed by using the Tampa Scale for Kinesiophobia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Other: STUDY

Detailed Description

Our study consists of 180 female participants aged between 18 and 65 years who applied to the physical therapy and rehabilitation outpatient clinic between April 2021 and August 2021. This case-control study was conducted according to the Declaration of Helsinki. Participants gave written voluntary consent and enrolled in this case-control study.

Ninety (90) woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria and 90 healthy volunteers were included. Fibromyalgia Impact Questionnaire, Tampa Kinesiophobia Scale, Fatigue Severity Scale and The short form of İnternational Physical Activity Questionnaire (IPAQ-SF) were completed. All scales were filled in face to face for the participants. In addition, demographic data (age, gender, height, weight, marital status, education level) and duration of fibromyalgia diagnosis were recorded.

Exclusion criteria for both groups; The presence of health problems that affect the level of physical activity ( Cardiac or pulmonary insufficiency, limb amputation, recent surgery history) and cognitive impairment that prevents answer questions

Study Type

Observational

Enrollment (Actual)

203

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Turkey
- Yozgat
  - Yerköy, Yozgat, Turkey, 66900
    - Yerkoy State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Ninety woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria and 90 healthy volunteers were included

Description

Inclusion Criteria:

Ninety (90) woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria
Ninety (90) healthy volunteers

Exclusion Criteria:

The presence of health problems that affect the level of physical activity ( Cardiac or pulmonary insufficiency, limb amputation, recent surgery history)
Cognitive impairment that prevents answer questions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
STUDY GROUP diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria	Other: STUDY Fibromyalgia Patient
CONTROL GROUP 90 healthy volunteers	Other: STUDY Fibromyalgia Patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fatigue Time Frame: Baseline (0 day)	The Fibromyalgia Impact Questionnaire (FIQ) is used to assess the patient's functionality and determine the severity of the disease. The scale consists of 10 items and each item is 10 points. Therefore, the total maximum score is 100 points. Increasing scores indicate higher disease activity and lower functional status	Baseline (0 day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinesiophobia Time Frame: Baseline (0 day)	The kinesiophobia level was assessed by using the Tampa Scale for Kinesiophobia (TSK). The TSK includes 17 item and assesses the subjective rating of kinesiophobia..Each item is scored by using a 4-point Likert-type scale, (1 point is reporting complete disagreement and 4 points is reporting complete agreement).The total points ranges between 17 and 68. Higher scores refer higher severity of kinesiophobia. Scores higher than 37 points mean high levels of kinesiophobia and scores less than or equal to 37 mean low levels of kinesiophobia	Baseline (0 day)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Levels Time Frame: Baseline (0 day)	The short form of the International Physical Activity Questionnaire (IPAQ-SF) contains 7 questions that provide information about sitting, walking, and moderate to vigorous intensity activities. The total score includes the duration (minutes) and frequency (days) of intense activity. The sitting score (sedentary behavior level) is calculated separately. Each activity needs to be done for at least 10 minutes at a time	Baseline (0 day)
functionality Time Frame: Baseline (0 day)	The Fibromyalgia Impact Questionnaire (FIQ) is used to assess the patient's functionality and determine the severity of the disease	Baseline (0 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yerkoy State Hospital

Investigators

Principal Investigator: Basak CigdemKaracay, Spesialist, Yerkoy State Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2021

Primary Completion (ACTUAL)

May 1, 2021

Study Completion (ACTUAL)

September 1, 2021

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria

March 31, 2021

First Posted (ACTUAL)

April 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

2017-KAEK-189_2021.03.10_18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Fatigue Levels in Fibromyalgia Syndrome