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

NCT ID: NCT06061016

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2023-11-02

Brief Summary

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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

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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.

Conditions

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Fibromyalgia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Physical Medicine Rehabilitation Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nur Kesiktas, MD

Role: STUDY_CHAIR

İstanbul Physical Therapy Rehabilitation Training & Research Hosptial

Locations

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Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 37354737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35177048 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36471309 (View on PubMed)

Other Identifiers

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IstPRMTRH2

Identifier Type: -

Identifier Source: org_study_id

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