AzTrials
AzTrials

FibromyalgiaNCT05210751

Dual Task in Female Patients With Fibromyalgia

An observational study of Fibromyalgia and Dual Task, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of our study is to examine the relationship between dual task and physical and psychosocial factors in female patients with fibromyalgia. We will perform Dual Task Test, 6 min Walking Test, the Baecke Habitual Physical Activity Questionnaire, Multidimensional Fatigue Inventory-20, Tracking Test, General… Read more about this study

Who is it for?
Ages 30 to 75 years, women only
Conditions the study is for
Fibromyalgia, Dual Task, Physical Function
What is being tested?
Physical and psychosocial assessments
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2021to 1 Dec 2022
How long will I take part?
1 Day
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 30 to 75 years
  • Women only
  • Adult, Older adult

Study population: - Women Women Patients aged 30-75 years diagnosed with fibromyalgia by a rheumatologist according to criteria set by the American College of Rheumatology and healthy control group

Who may be able to join

  • Women aged 30-75 years
  • Patients diagnosed with fibromyalgia by a rheumatologist according to criteria set by the American College of Rheumatology
  • Patients who can communicate effectively with study staff.
  • Patients who have read, understood and signed the informed consent form

Who cannot join

  • Those who are pregnant
  • Participants who could not sit and stand in a chair even once, or climb stairs unaided
  • Other rheumatic diseases and other severe somatic or psychiatric disorders such as cancer, severe coronary disease, or other serious somatic or psychiatric disorders such as schizophrenia

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • İlknur Naz Gürşan

    Izmir, 35620

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Relationship Between Dual Task With Physical and Psychosocial Factors in Female Patients With Fibromyalgia

The aim of our study is to examine the relationship between dual task and physical and psychosocial factors in female patients with fibromyalgia.

We will perform Dual Task Test, 6 min Walking Test, the Baecke Habitual Physical Activity Questionnaire, Multidimensional Fatigue Inventory-20, Tracking Test, General Self-Efficacy Scale the Toronto Alexithymia Scale, the Revised FM Impact Questionnaire, the Social Support Scale.

Read the detailed description

Dual-tasking is a procedure that requires an individual to perform two tasks simultaneously to compare performance with single-task conditions, and the characteristics associated with dual-task performance in patients with fibromyalgia are unclear. Therefore, in our study, we focused on examining the relationship between dual task and physical and psychosocial factors.

Patients with a diagnosis of fibromyalgia will be included in our study.

Dual-task assessment of women with FM is with the "Dual Task Test", aerobic capacity with the "6 min Walking Test", physical activity level with the "Baecke Habitual Physical Activity Questionnaire", fatigue levels with the "Multidimensional Fatigue Inventory-20", cognitive levels With the "Tracking Test", self-efficacy levels with the "General Self-Efficacy Scale", alexithymia levels with the "Toronto Alexithymia Scale", quality of life with the "Revised FM Impact Questionnaire", motivation levels with the "Social Support Scale" will be evaluated .

Being tested
Physical and psychosocial assessments
Keywords
Fibromyalgia, dual task, physical function, Psychosocial Problem
Medical subject headings
Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical and psychosocial assessmentsOther

    Dual Task Test, 6 min Walking Test, the Baecke Habitual Physical Activity Questionnaire, Multidimensional Fatigue Inventory-20, Tracking Test, General Self-Efficacy Scale the Toronto Alexithymia Scale, the Revised FM Impact Questionnaire, the Social Support Scale.

Study groups in NCT05210751
Study groupRoleWhat they receive
Women patients with fibromyalgiawomen with fibromyalgia beween age 30-75
Receives: Other: Physical and psychosocial assessments
Control groupHealthy female volunteers aged 30-75 years
Receives: Other: Physical and psychosocial assessments

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dual Task Assessment

    Timed Up and Go Test: Participants are required to get up from the chair without assistance from their arms, walk 3 meters as fast as possible without running, turn their backs, walk back to the chair, and sit without assistance from their arms. The dual-task condition is performed by counting aloud backwards by twos, starting with a random number greater than 100 while performing the tests. Test result is saved in seconds

    Measured: 5 minutes

Secondary outcomes (8)
  1. Functional capacity

    Six minute walk tests: Patients are asked to walk as fast as possible at their own walking pace for 6 minutes on a 30-meter straight corridor. At the end of the test, the walking distance is recorded.

    Measured: 15 minutes

  2. Physical Activity Assessment

    Baecke Habitual Physical Activity Questionnaire (BPAQ): The BPAQ is a self-report questionnaire to assess routine physical activity. The Baecke questionnaire is a tool that evaluates individual's habitual physical activities over the previous 12 months. This questionnaire consists of 16 questions within three main domains of individual physical activities (occupational, sport, and recreational), in the previous 12 months. Measurement of individual physical activities is achieved by calculating the sum of the scores obtained from occupational, sport, and recreational categories

    Measured: 15 minutes

  3. Fatigue Assessment

    Multidimensional Fatigue Inventory-20 (MPI): Evaluates 5 dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, motivation and activity. MPI consists of 20 questions in total, with 4 questions in each subscale. Questions score between 1 and 5. The score of each subscale ranges from 4 (best) to 20 (worst).

    Measured: 10 minutes

  4. Self-Efficacy Assessment

    General Self-Efficacy Scale: The scale is a 10-item Likert-type four-point scale (1= not suitable for me at all, 2= somewhat suitable for me, 3= mostly suitable for me, 4= completely suitable for me). All items in the scale included positive statements, and those who participated in the scale were asked to answer each item using ratings ranging from "totally suitable for me" to "not at all suitable for me".

    Measured: 10 minutes

  5. Alexithymia Assessment

    Toronto Alexithymia Scale: Toronto Alexithymia Scale (TAS-20), a 20-item Likert-type self-rating scale, scored between 1-5 as "1=never" and "5=always", "Difficulty Recognizing Emotions", "Speaking Emotions" It consists of three subscales: Difficulty in Pouring and Expressive Thinking. The Difficulty Recognizing Emotions subscale consisted of seven items (items 1, 3, 6, 7, 9, 13, 14); The Difficulty in Expressing Emotions subscale includes five items (items 2, 4, 11, 12, 17) and the Expressive Thinking subscale includes eight items (items 5, 8, 10, 15, 16, 18, 19, 20). Items 4, 5, 10, 18 and 19 are scored in reverse order. High scores from the scale indicate a high level of alexithymia.

    Measured: 15 minutes

  6. Fibromyalgia Impact Assessment

    Revised Fibromyalgia Impact Questionnaire: The revised Fibromyalgia Impact Questionnaire is a questionnaire that evaluates the limitations and functional disability of patients with fibromyalgia with a total of 21 questions in three sections: function, general and symptoms. All questions are evaluated on a numerical scale between 0-10. A score of 70 and above indicates severe disability in this patient group. The higher the score obtained from the questionnaire, the higher the disability due to fibromyalgia.

    Measured: 20 minutes

  7. Assessment of Social Support

    Medical Outcome Study Social Support Scale (MOS-SSS): The first item assesses the number of close relatives and friends (structural social support). The remaining 19 items of the test are answered on a 5-point Likert-type scale ranging from 1 (never) to 5 (always). The test consists of four sub-dimensions: emotional-informational support (8 items), positive interaction (3 items), love support (4 items), and concrete support (3 items).

    Measured: 20 minutes

  8. Cognitive Assessment

    Trail Making Test: This test evaluates attention speed, mental flexibility, visual scanning and motor-speed. In part A, points 1-25 are combined with a single continuous line, in part B, a letter is combined with a number alternately. Part B has also been reported to be an indicator of executive functions. In the evaluation of the test, time and error numbers were used in the literature, but it was also reported that only the time could be used with the effect of the error on the time score by returning the last item without error to the last point reached without error. In our study, this method will be followed and only time scores will be evaluated.

    Measured: 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2022
  2. Study start1 Nov 2021
  3. Primary completion1 Nov 2022
  4. Study completion1 Dec 2022

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
80 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT05210751
Sponsor's protocol ID
FM111
Status last verified
Sep 2023
First submitted
13 Jan 2022
Last updated
29 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Fibromyalgia and Dual Task, run by Izmir Katip Celebi University 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 4 inclusion and 3 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 29 Sep 2023. 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?

Dual Task Assessment (time frame: 5 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Sep 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in