NCT05210751

Brief 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 Self-Efficacy Scale the Toronto Alexithymia Scale, the Revised FM Impact Questionnaire, the Social Support Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

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

November 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

January 13, 2022

Last Update Submit

September 27, 2023

Conditions

Keywords

Fibromyalgiadual taskphysical functionPsychosocial Problem

Outcome Measures

Primary Outcomes (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

    5 minutes

Secondary Outcomes (8)

  • Functional capacity

    15 minutes

  • Physical Activity Assessment

    15 minutes

  • Fatigue Assessment

    10 minutes

  • Self-Efficacy Assessment

    10 minutes

  • Alexithymia Assessment

    15 minutes

  • +3 more secondary outcomes

Study Arms (2)

Women patients with fibromyalgia

women with fibromyalgia beween age 30-75

Other: Physical and psychosocial assessments

Control group

Healthy female volunteers aged 30-75 years

Other: Physical and psychosocial assessments

Interventions

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.

Control groupWomen patients with fibromyalgia

Eligibility Criteria

Age30 Years - 75 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İlknur Naz Gürşan

Izmir, 35620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

January 13, 2022

First Posted

January 27, 2022

Study Start

November 1, 2021

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations