FibromyalgiaNCT06061016
Validity and Reliability of the 2-minute Step Test in Patients With Fibromyalgia
An observational study of Fibromyalgia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 2 Nov 2023
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Neuromuscular disease
- Pregnancy
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul
About this study
Official title: Construct Validity and Reliability of the 2-minute Step Test in Patients With Fibromyalgia
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.
- Conditions
- Fibromyalgia
- Being tested
- No intervention
- Keywords
- Fibromyalgia, Exercise test, Physical fitness
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 7
Secondary outcomes (5)
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.
Measured: Baseline
Two-minute walk test
The distance the patient walked for two minutes was measured. The result is expressed in meters.
Measured: Baseline
Fibromyalgia Impact Questionaire
impact of life quality. The total score can be between 0-80 points. A score of 80 indicates maximum impact.
Measured: Baseline
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
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Oct 2023
- Primary completion1 Nov 2023
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nur Kesiktas, MD, Study chair, İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061016
- Sponsor's protocol ID
- IstPRMTRH2
- Status last verified
- Feb 2024
- First submitted
- 24 Sep 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 37354737de 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 35177048de 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construct Validity and Reliability of the 2-minute Step Test in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT06061016
- Acronym / sponsor ID
- IstPRMTRH2
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Exercise test, Physical fitness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Two-minute step test
Time frame: 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.
5 secondary outcomes
Six-minute walk test
Time frame: Baseline
Two-minute walk test
Time frame: Baseline
Fibromyalgia Impact Questionaire
Time frame: Baseline
Fatigue Severity Scale
Time frame: Baseline
Visual Analogue Scale
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 37354737McCain 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.
- Background: PubMed 35177048de 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.
- Background: PubMed 36471309de 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nur Kesiktas, MD study chair
İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-minute step test (time frame: Baseline and Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06061016, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.