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

Completed
Conditions
Fibromyalgia
Registration Number
NCT06061016
Lead Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Brief Summary

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).

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
55
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Two-minute step testBaseline 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 Outcome Measures
NameTimeMethod
Six-minute walk testBaseline

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.

Two-minute walk testBaseline

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

Visual Analogue ScaleBaseline

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.

Fatigue Severity ScaleBaseline

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

Fibromyalgia Impact QuestionaireBaseline

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

Trial Locations

Locations (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

🇹🇷

Istanbul, Turkey

Istanbul Physical Medicine Rehabilitation Training and Research Hospital
🇹🇷Istanbul, Turkey
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