NCT05926986

Brief Summary

Accumulating research with human adults suggests that a single session of physical exercise ameliorates different aspects of cognitive function immediately after the end of the exercise period, regardless of fitness level. It has now been more clearly demonstrated that the effect of physical exercise on cognitive performance depends both on the intensity and the duration of the exercise. Fibromyalgia (FM) is a complex clinical syndrome characterized by chronic widespread musculoskeletal pain, sleep disturbances, morning stiffness, fatigue, anxiety, and depressive symptoms. The aim of the study is to investigate the effects of exercise on cognitive functions in patients with FM.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 23, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

June 23, 2023

Last Update Submit

June 23, 2023

Conditions

Fibromyalgia

Keywords

Fibromyalgiacognitive functionsexercise

Outcome Measures

Primary Outcomes (1)

  • The Stroop Color and Word Test

    The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used for both experimental and clinical purposes. It assesses the ability to inhibit cognitive interference, which occurs when the processing of a stimulus feature affects the simultaneous processing of another attribute of the same stimulus

    2 minutes

Secondary Outcomes (2)

  • Beck Depression Inventory

    1 minute

  • Verbal Fluency test

    2 minutes

Study Arms (2)

Study group

EXPERIMENTAL

Aerobic exercise will be performed to all participants for a single session. Maximum heart rate was calculated for each subject (220 - age) and a heart rate monitor (Polar FT 100, China) will be used to follow subjects' heart rate during aerobic exercise. Additionally, pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.

Other: Exercise

Control group

EXPERIMENTAL

No additional treatment will be practiced to the control group.

Other: control

Interventions

ExerciseOTHER

Aerobic exercise will be performed to all participants for a single session. Maximum heart rate was calculated for each subject (220 - age) and a heart rate monitor (Polar FT 100, China) will be used to follow subjects' heart rate during aerobic exercise. Additionally, pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.

Study group
controlOTHER

No additional treatment will be practiced to the control group.

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who were aged between 18-65 years,
  • Patients who got diagnosed with Fibromyalgia Syndrome

You may not qualify if:

  • Patients who had regular exercise habits, malignancy, pregnancy, incorporation,
  • Patients who had changes of medical treatment in last 3 months
  • Patients who diagnosed with Osteoarthritis for lower extremity
  • Patients who had cardiac symptoms according to New York Heart Association
  • Patients who had dysfunction that can prevent physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Songül Bağlan Yentür

Elâzığ, 23100, Turkey (Türkiye)

RECRUITING

Related Links

MeSH Terms

Conditions

FibromyalgiaMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Songül Bağlan Yentür

    Firat University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Songül Bağlan Yentür

CONTACT

+90 424 2370000sbyentur@firat.edu.tr

Şahin Elbastı

CONTACT

+90 424 2370000msahin23@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Firat University

Study Record Dates

First Submitted

June 23, 2023

First Posted

July 3, 2023

Study Start

July 20, 2023

Primary Completion

September 20, 2023

Study Completion

October 20, 2023

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)