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CompletedNCT06969716Updated Mar 20, 2026

Frequency of Fibromyalgia Syndrome in Elderly Patients Aged 80 and Above and Its Relationship With Geriatric Parameters

An observational study in Fibromyalgia and Old Age; Debility, sponsored by Sultan 1. Murat State Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 80 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-20.

Sponsored by Sultan 1. Murat State Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
420
Ages
80 Years and older
Sex
All
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Study summary

The aim of this study was to determine the prevalence of fibromyalgia syndrome in patients aged 80 years and over and to examine the relationship between detailed geriatric assessment parameters and fibromyalgia syndrome.

02

Conditions studied

  • Fibromyalgia
  • Old Age; Debility
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In context

Fibromyalgia

1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.

This study's enrollment of 420 is above the median of 100 across 279 observational studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Sultan 1. Murat State Hospital is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
80 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients aged 80 and over who are followed up from the healthy aging outpatient clinic of Edirne Sultan 1. Murat State Hospital geriatric clinic will be included in the study

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 80 and above
  • Patients with complete detailed geriatric assessment parameters

Exclusion criteria

Exclusion Criteria:

  • Presence of neurodegenerative disease (dementia, parkinsonism)
  • Immobilized patient
  • Those who have had an acute illness (infection, fracture, cerebrovascular disease) in the last month
  • Having psychotic disorders
  • Having severe hearing loss
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
420 participants (actual)
Patient registry
No

Groups and cohorts

  • Elderly Patients

    Age 80 and above

    Other: Detailed geriatric assessment

Interventions

  • OtherDetailed geriatric assessment

    The demographic characteristics of the patients, comorbid diseases, history and number of falls in the last 6 months will be questioned, and the thyroid stimulating hormone, calciferol, cobalamin, glycosylated hemoglobin, folic acid and glomerular filtration rate levels routinely requested from each patient in the last 3 months will be recorded. During the outpatient clinic application, the patients will undergo neurocognitive assessment, mood assessment, daily living activities assessment, balance and walking assessment, nutritional assessment and frailty assessment. The patients' handgrip strength from their dominant hand will be assessed with a hand dynamometer. The walking speed of the patients will be measured as the number of seconds it takes to walk 4 meters and recorded in seconds. All patients will be questioned about the presence of body pain with the numerical pain scale score and all patients will be evaluated for the presence of fibromyalgia syndrome.

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What researchers measure

Primary outcomes

  1. Presence of fibromyalgia syndrome

    The presence of fibromyalgia will be evaluated using the 2016 American College of Rheumatology diagnostic criteria.

    Time frame: Baseline

Secondary outcomes

  1. Neurocognitive assessment

    Neurocognitive assessment will be done with Mini Mental State Examination (MMSE). MMSE test is a short screening test with 11 questions and 30 points. MMSE is completed in approximately 10 minutes and evaluates orientation, memory, attention, calculation, recall, language, motor function and perception, visual-spatial abilities. 24-30 points is normal, 18-23 points is mild dementia, 17 and below is compatible with severe dementia.

    Time frame: Baseline

  2. Mood assessment

    Mood assessment will be assessed with the Geriatric Depression Scale-short form (GDS-SF). GDS-SF consists of 15 questions that patients answer yes or no. Scoring is done as the number of yes answers, and the total depression score is calculated from the sum of the scores. Scores between 0-9 are considered "normal", scores between 10-19 are considered "mild depression", and scores between 20-30 are considered "severe depression".

    Time frame: Baseline

  3. Daily living activities

    The assessment of daily living activities will be assessed with the Lawton-Brody Instrumental Activities of Daily Living Scale (IADLS). IADLS consists of 8 questions that include information on using the telephone, preparing meals, shopping, doing daily housework, doing laundry, being able to get on a vehicle, being able to use medications, and managing money. 0-8 points are evaluated as "dependent," 9-16 points as "semi-dependent," and 17-24 points as "independent."

    Time frame: Baseline

  4. Balance and walking assessment

    Balance and walking assessment will be assessed with the Tinetti Performance-Oriented Mobility Assessment (POMA). POMA assesses balance ability and walking under 2 main headings. The first 9 questions are about balance, the next 7 questions are about walking. Calculation of the survey score; the total score of the first 9 items gives the balance score, the total score of the next 7 items gives the walking score, and the sum of the balance and walking scores gives the total POMA score. Individuals with a score of 18 and below are considered to have poor balance and walking.

    Time frame: Baseline

  5. Nutritional assessment

    Nutritional assessment will be evaluated with the Mini Nutritional Assessment questionnaire-short form (MNA-SF). MNA-SF consists of 5 subheadings; those with 12-14 points are considered "no risk of malnutrition", those with 8-11 points are considered "at risk of malnutrition" and those with 0-7 points are considered "malnourished".

    Time frame: Baseline

  6. Frailty

    Frailty will be assessed using the Clinical Frailty Scale (CFS). CFS is graded from 1 to 9. The higher the score, the greater the frailty.

    Time frame: Baseline

  7. Activities of daily living

    The assessment of daily living activities will be assessed with the the Barthel Index (BI) scale. BI consists of 10 questions that evaluate feeding, washing, self-care, dressing, defecation control, urinary control, going to the toilet, the ability to get from bed to a wheelchair, mobility status such as walking or being wheelchair dependent, and climbing stairs. 0-20 points are considered as completely dependent, 21-61 points as severely dependent, 62-90 points as moderately dependent, 91-99 points as slightly dependent, and 100 points as completely independent.

    Time frame: Baseline

07

Study locations

1 site
  • Sultan 1. Murat State Hospital
    Edirne, 22030, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: Yes — If requested, the data of the study will be shared by the researchers.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2025 to primary completion in Mar 2026, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 3, 2025
First posted
May 14, 2025
StartActual
May 1, 2025
Primary completionActual
Mar 3, 2026
CompletionActual
Mar 3, 2026
Last update
Mar 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06969716
Lead sponsor
Sultan 1. Murat State Hospital
Responsible party
Alper Mengi (Associate Professor, Sultan 1. Murat State Hospital) — Principal investigator
First posted
May 14, 2025
Start date
May 1, 2025
Primary completion
Mar 3, 2026
Completion
Mar 3, 2026
Last update
Mar 20, 2026

Study contacts

Kübra Altunkalem Seydi, MD
principal investigator · Sultan 1. Murat State Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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