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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06061016
• Other study ID #: IstPRMTRH2
• Status: Completed
• Start date: October 1, 2023
• Est. completion date: November 2, 2023

Study information

• Verified date: February 2024
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 2, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine Rehabilitation Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two-minute step test	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.	Baseline and Day 7
Secondary	Six-minute walk test	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.	Baseline
Secondary	Two-minute walk test	The distance the patient walked for two minutes was measured. The result is expressed in meters.	Baseline
Secondary	Fibromyalgia Impact Questionaire	impact of life quality. The total score can be between 0-80 points. A score of 80 indicates maximum impact.	Baseline
Secondary	Fatigue Severity Scale	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	Baseline
Secondary	Visual Analogue Scale	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.	Baseline