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Completed

NCT Number: NCT04827550

Fatigue Levels in Fibromyalgia Syndrome

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Yerkoy State Hospital

Yerköy, Yozgat, 66900, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STUDY

Other

Fibromyalgia Patient

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Yerkoy State Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2021
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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