NCT06678932

Brief Summary

The aim of this study is to compare the upper extremity exercise capacity, muscle strength and activities of daily living of patients with fibromyalgia syndrome and healthy individuals.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

November 1, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 6, 2024

Last Update Submit

November 6, 2024

Conditions

Fibromyalgia Syndrome

Outcome Measures

Primary Outcomes (4)

  • Upper extremity exercise capacity

    This will be evaluated with arm ergometer test.

    1st day

  • Muscle strength

    Hand grip strength will be measured using a hand grip dynamometer.

    1st day

  • Muscle endurance

    30 second push-up test will be used, and total number will be recorded.

    1st day

  • Activities of daily living

    It will be evaluated with the Glittre Activities of Daily Living test, and total time will be recorded.

    1st day

Study Arms (2)

Fibromyalgia syndrome

Healthy controls

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with fibromyalgia syndrome and healthy individuals will be included in the study.

You may qualify if:

  • Being diagnosed with fibromyalgia syndrome
  • Being aged 18-65
  • Stable use of medication for at least 3 months or longer
  • Volunteering to participate in the study

You may not qualify if:

  • Having comorbidities that may affect physical functions
  • Failure to cooperate with tests to be performed
  • Presence of exercise test contraindication
  • Being aged 18-65
  • Volunteering to participate in the study
  • Having a chronic or systemic disease
  • Failure to cooperate with tests to be performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirsehir Ahi Evran University

Kırşehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Basak Kavalci Kol

    Kirsehir Ahi Evran University

    STUDY CHAIR

  • Figen Tuncay

    Kirsehir Ahi Evran University

    STUDY CHAIR

Central Study Contacts

Merve Firat

CONTACT

+90 850 441 02 44mervefirat@ahievran.edu.tr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 6, 2024

First Posted

November 7, 2024

Study Start

November 1, 2024

Primary Completion

May 1, 2025

Study Completion

December 1, 2025

Last Updated

November 7, 2024

Record last verified: 2024-11

Locations

TU(1)