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Completed

NCT Number: NCT06061016

Validity and Reliability of the 2-minute Step Test in Patients With Fibromyalgia

The objective of this study was twofold: first, to assess the validity and reliability of the 2 Minute Step Test (2MST) in patients with fibromyalgia; and second, to explore its relationship with objective assessment methods, specifically the 2 Minute Walk Test (2MWT) and the 6 Minute Walk Test (6MWT). Additionally, the study aimed to investigate the correlation between the 2MST and quality of life as well as chronic fatigue levels using the Fibromyalgia Impact Questionnaire (FIQ) and the Fatigue Severity Scale (FSS).

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

This cross-sectional study will include 55 female patients aged 18-65 who will be diagnosed with fibromyalgia according to the American College of Rheumatology 2010 Diagnostic Criteria. Demographic characteristics of the patients will be documented. The extent of impact on patients' quality of life will be evaluated using the Fibromyalgia Impact Questionnaire (FIQ), while the severity of chronic fatigue will be measured using the Fatigue Severity Scale (FSS). The intensity of chronic pain experienced by patients will be expressed using the Visual Analogue Scale (VAS). All patients will undergo an initial assessment using the 2-Minute Step Test (2MST), 2-Minute Walk Test (2MWT), and 6-Minute Walk Test (6MWT). To assess test-retest reliability, the 2MST will be repeated with a 7-day interval between assessments.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Having been diagnosed with fibromyalgia according to the American College of Rheumatology 2010 Diagnostic Criteria
  • Female patients aged 18-65
  • The absence of any pathological condition that would hinder walking

Exclusion criteria

  • Uncontrolled hypertension
  • Decompensated heart failure
  • Presence of systemic diseases affecting lower extremity functions
  • Presence of degenerative diseases affecting lower extremity functions
  • Peripheral artery disease causing vascular claudication
  • Psychiatric illness
  • Neuromuscular disease
  • Pregnancy
  • Cognitive impairment

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Two-minute step test

    Time frame: Baseline and Day 7

    The patient was instructed to lift their knees to the minimum marked level and take as many steps as possible in place for a duration of two minutes.

Secondary outcomes

  1. Six-minute walk test

    Time frame: Baseline

    The distance the patient walked for six minutes was measured. An increase in the distance walked indicates improvement in basic mobility. The result is expressed in meters.

  2. Two-minute walk test

    Time frame: Baseline

    The distance the patient walked for two minutes was measured. The result is expressed in meters.

  3. Fibromyalgia Impact Questionaire

    Time frame: Baseline

    impact of life quality. The total score can be between 0-80 points. A score of 80 indicates maximum impact.

  4. Fatigue Severity Scale

    Time frame: Baseline

    description fatigue level. The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue on you. If 2.8<, no fatigue; If >6.1, chronic fatigue syndrome

  5. Visual Analogue Scale

    Time frame: Baseline

    The pain VAS is a unidimensional measure of pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

Construct Validity and Reliability of the 2-minute Step Test in Patients With Fibromyalgia

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 29, 2023
Registry last updated
Feb 20, 2024

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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