Clinical trial NCT06061016: Validity and Reliability of the 2-minute Step Test in Patients With Fibromyalgia
Official title: Construct Validity and Reliability of the 2-minute Step Test in Patients With Fibromyalgia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Exercise test
Physical fitness
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-09-29
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: * 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Two-minute step test
timeFrame: Baseline and Day 7
Secondary outcomes:
measure: Six-minute walk test
timeFrame: Baseline
measure: Two-minute walk test
timeFrame: Baseline
measure: Fibromyalgia Impact Questionaire
timeFrame: Baseline
measure: Fatigue Severity Scale
timeFrame: Baseline
measure: Visual Analogue Scale
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study officials:
affiliation: İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
name: Nur Kesiktas, MD
role: STUDY_CHAIR
References:
citation: McCain A, McGibbon C, Carroll M, MacKenzie E, Senechal M, Bouchard DR. Validity of common physical function tests performed online for older adults. Arch Gerontol Geriatr. 2023 Nov;114:105104. doi: 10.1016/j.archger.2023.105104. Epub 2023 Jun 15.
citation: de Morais Almeida TF, Dibai-Filho AV, de Freitas Thomaz F, Lima EAA, Cabido CET. Construct validity and reliability of the 2-minute step test in patients with knee osteoarthritis. BMC Musculoskelet Disord. 2022 Feb 17;23(1):159. doi: 10.1186/s12891-022-05114-1.
citation: de Jesus SFC, Bassi-Dibai D, Pontes-Silva A, da Silva de Araujo A, de Freitas Faria Silva S, Veneroso CE, de Paula Gomes CAF, Dibai-Filho AV. Construct validity and reliability of the 2-Minute Step Test (2MST) in individuals with low back pain. BMC Musculoskelet Disord. 2022 Dec 5;23(1):1062. doi: 10.1186/s12891-022-06050-w.