NCT06061016

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

September 24, 2023

Last Update Submit

February 18, 2024

Conditions

Fibromyalgia

Keywords

FibromyalgiaExercise testPhysical fitness

Outcome Measures

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.

    Baseline and Day 7

Secondary Outcomes (5)

  • Six-minute walk test

    Baseline

  • Two-minute walk test

    Baseline

  • Fibromyalgia Impact Questionaire

    Baseline

  • Fatigue Severity Scale

    Baseline

  • Visual Analogue Scale

    Baseline

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 37354737BACKGROUND

  • 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.

    PMID: 35177048BACKGROUND

  • 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.

    PMID: 36471309BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Nur Kesiktas, MD

    İstanbul Physical Therapy Rehabilitation Training & Research Hosptial

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Week
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2023

First Posted

September 29, 2023

Study Start

October 1, 2023

Primary Completion

November 1, 2023

Study Completion

November 2, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)