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CompletedNCT06061016Updated Feb 20, 2024

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

An observational study in Fibromyalgia, sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
55
Ages
18 Years to 65 Years
Sex
Female
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Study 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).

Read the 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.

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Conditions studied

  • Fibromyalgia

Keywords

  • Fibromyalgia
  • Exercise test
  • Physical fitness
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In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

This study's enrollment of 55 is below the median of 100 across 270 observational studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital is the lead sponsor of 119 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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

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

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
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
55 participants (actual)
Target follow-up
1 Week
Patient registry
Yes

Interventions

  • OtherNo intervention

    No intervention

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and Day 7

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. Two-minute walk test

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

    Time frame: Baseline

  3. Fibromyalgia Impact Questionaire

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

    Time frame: Baseline

  4. 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

    Time frame: Baseline

  5. 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.

    Time frame: Baseline

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Study locations

1 site
  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital
    Istanbul, Turkey
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References and documents

Publications

  • 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. PubMed 37354737 ↗
  • 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. PubMed 35177048 ↗
  • 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. PubMed 36471309 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06061016
Lead sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Responsible party
Sponsor
First posted
Sep 29, 2023
Start date
Oct 1, 2023
Primary completion
Nov 1, 2023
Completion
Nov 2, 2023
Last update
Feb 20, 2024

Study contacts

Nur Kesiktas, MD
study chair · İstanbul Physical Therapy Rehabilitation Training & Research Hosptial

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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