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).
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.
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 .
- Conditions
- Fibromyalgia, Dual Task, Physical Function, Psychosocial Problem
- 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 group | Role | What they receive |
|---|---|---|
| Women patients with fibromyalgia | women with fibromyalgia beween age 30-75 Receives: Other: Physical and psychosocial assessments | |
| Control group | Healthy 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.
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)
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
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
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
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
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
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
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
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.
- First posted27 Jan 2022
- Study start1 Nov 2021
- Primary completion1 Nov 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Naz, Izmir Katip Celebi University
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Dual Task With Physical and Psychosocial Factors in Female Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT05210751
- Acronym / sponsor ID
- FM111
- Conditions
- Fibromyalgia, Dual Task, Physical Function, Psychosocial Problem
- Keywords
- Fibromyalgia, dual task, physical function, Psychosocial Problem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 27 Jan 2022 (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 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.
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 .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women patients with fibromyalgia | – | Other: Physical and psychosocial assessmentswomen with fibromyalgia beween age 30-75 |
| Control group | – | Other: Physical and psychosocial assessmentsHealthy female volunteers aged 30-75 years |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Age groups
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Physical and psychosocial assessmentsDual 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. | Other | Control group, Women patients with fibromyalgia |
Primary outcome
Dual Task Assessment
Time frame: 5 minutes
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
8 secondary outcomes
Functional capacity
Time frame: 15 minutes
Physical Activity Assessment
Time frame: 15 minutes
Fatigue Assessment
Time frame: 10 minutes
Self-Efficacy Assessment
Time frame: 10 minutes
Alexithymia Assessment
Time frame: 15 minutes
Fibromyalgia Impact Assessment
Time frame: 20 minutes
Assessment of Social Support
Time frame: 20 minutes
Cognitive Assessment
Time frame: 20 minutes
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 29 Sep 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 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.