NCT06969716

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
420

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2025

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

Study Start

First participant enrolled

May 1, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2026

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

May 3, 2025

Last Update Submit

March 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence of fibromyalgia syndrome

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

    Baseline

Secondary Outcomes (7)

  • Neurocognitive assessment

    Baseline

  • Mood assessment

    Baseline

  • Daily living activities

    Baseline

  • Balance and walking assessment

    Baseline

  • Nutritional assessment

    Baseline

  • +2 more secondary outcomes

Study Arms (1)

Elderly Patients

Age 80 and above

Other: Detailed geriatric assessment

Interventions

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.

Elderly Patients

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan 1. Murat State Hospital

Edirne, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FibromyalgiaFrailty

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kübra Altunkalem Seydi, MD

    Sultan 1. Murat State Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 3, 2025

First Posted

May 14, 2025

Study Start

May 1, 2025

Primary Completion

March 3, 2026

Study Completion

March 3, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

If requested, the data of the study will be shared by the researchers.

Locations