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

Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06061016
Collaborator
(none)
55
1
1.1
52.3

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
55 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Construct Validity and Reliability of the 2-minute Step Test in Patients With Fibromyalgia
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 2, 2023

Outcome Measures

Primary Outcome Measures

  1. Two-minute step test [Baseline 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

  1. Six-minute walk test [Baseline]

    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.

  2. Two-minute walk test [Baseline]

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

  3. Fibromyalgia Impact Questionaire [Baseline]

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

  4. Fatigue Severity Scale [Baseline]

    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

  5. Visual Analogue Scale [Baseline]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul Turkey

Sponsors and Collaborators

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

  • Study Chair: Nur Kesiktas, MD, İstanbul Physical Therapy Rehabilitation Training & Research Hosptial

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT06061016
Other Study ID Numbers:
  • IstPRMTRH2
First Posted:
Sep 29, 2023
Last Update Posted:
Sep 29, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2023