Investigation of Core Endurance in Fibromyalgia

Investigation of Balance and Core Endurance in Patients With Fibromyalgia Syndrome

The aim of this study is to compare core endurance and balance in patients with Fibromyalgia Syndrome (FMS) with healthy subjects and to evaluate the relationship between core endurance and balance.The study will include 44 FMS patients and 44 age- and sex-matched healthy controls. Demographic data of the participants will be recorded. Then, core endurance will be assessed with McGill core endurance tests, balance will be evaluated with HUR BTG4 Balance Master System and Berg Balance Scale (BBS), and function will be assessed with Fibromyalgia Impact Questionnaire (FIQ).

Study Overview

• Status: Recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Fibromyalgia group; Other: Healthy group

Detailed Description

Fibromyalgia Syndrome (FMS) is defined as a chronic disease with an unclear etiology, which is characterized by widespread musculoskeletal pain, mainly non-inflammatory, in females between 40-60 years of age, accompanied by fatigue, weakness, sleep problems, depression, anxiety and various cognitive and somatic disorders. The etiology and pathophysiology are still unclear. Balance is a key component of activities of daily living such as walking, running and climbing stairs. Maintaining an upright posture is a complex process that involves perceiving and integrating sensory inputs, planning movements, and executing them effectively. It is also defined as the ability to control the center of gravity within the base of support. The aim of this study is to compare core endurance and balance in patients with Fibromyalgia Syndrome (FMS) with healthy subjects and to evaluate the relationship between core endurance and balance.The study will include 44 FMS patients and 44 age- and sex-matched healthy controls. Demographic data of the participants will be recorded. Then, core endurance will be assessed with McGill core endurance tests, balance will be evaluated with HUR BTG4 Balance Master System and Berg Balance Scale (BBS), and function will be assessed with Fibromyalgia Impact Questionnaire (FIQ).

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• Turkey
  • Elazığ, Turkey, 23100
    • Recruiting
    • Songul Baglan Yentur
    • Contact: Songul Baglan Yentur; Phone Number: 04242370000; Email: songulbaglan23@hotmail.com
    • Contact: Songul Baglan Yentur; Phone Number: +904242370000; Email: songulbaglan23@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients aged 18-65 years, diagnosed with FMS by clinical and physical examination, who agreed to participate in the study were included in the study. Patients with a diagnosis of severe spinal stenosis, concomitant systemic inflammatory rheumatic disease, pregnancy, malignancy or infection, history of surgery in the last 3 months, and physical problems that would prevent the application of core endurance tests were excluded.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients who had regular exercise habits, malignancy, pregnancy, incorporation
• Patients who had changes of medical treatment in last 3 months
• Patients who had dysfunction that can prevent physical activity

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fibromyalgia group; Demographic information (age, height, weight, occupation, medication, smoking) of the individuals who agreed to participate in the study will be recorded. Then, static and dynamic core endurance tests will be performed to evaluate core endurance. Static core endurance tests will include side bridge test, trunk flexion test, trunk extension test and prone bridge test. Modified push-ups and sit-ups tests will be performed as dynamic core endurance tests. Functional status of the patients will be evaluated with the Fibromyalgia Impact Questionnaire. Static and dynamic balance assessment will be evaluated using the HUR BTG4 Balance Master System and Berg Balance Scale.	Other: Fibromyalgia group; Demographic information (age, height, weight, occupation, medication, smoking) of the individuals who agreed to participate in the study will be recorded. Then, static and dynamic core endurance tests will be performed to evaluate core endurance. Static core endurance tests will include side bridge test, trunk flexion test, trunk extension test and prone bridge test. Modified push-ups and sit-ups tests will be performed as dynamic core endurance tests. Functional status of the patients will be evaluated with the Fibromyalgia Impact Questionnaire. Static and dynamic balance assessment will be evaluated using the HUR BTG4 Balance Master System and Berg Balance Scale.
Healthy group; individuals who agreed to participate in the study will be recorded. Then, static and dynamic core endurance tests will be performed to evaluate core endurance. Static core endurance tests will include side bridge test, trunk flexion test, trunk extension test and prone bridge test. Modified push-ups and sit-ups tests will be performed as dynamic core endurance tests. Static and dynamic balance assessment will be evaluated using the HUR BTG4 Balance Master System and Berg Balance Scale.	Other: Healthy group; Demographic information (age, height, weight, occupation, medication, smoking) of the individuals who agreed to participate in the study will be recorded. Then, static and dynamic core endurance tests will be performed to evaluate core endurance. Static core endurance tests will include side bridge test, trunk flexion test, trunk extension test and prone bridge test. Modified push-ups and sit-ups tests will be performed as dynamic core endurance tests. Static and dynamic balance assessment will be evaluated using the HUR BTG4 Balance Master System and Berg Balance Scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side bridge test	Participants will be asked to lift their hips off the floor in a side lying position with support from the elbow and forearm. After the patients will place their whole body in a straight line on their feet and elbows, the time was started to be kept with a stopwatch. The time will be maintained for the right and left side was recorded as a score.	up to 2 weeks
Trunk flexion test	Participants will be asked to position the upper trunk at 60⁰ flexion while the hips and knees will be in the 90⁰ flexion position. The time the patients could stand while maintaining this angle will be recorded.	up to 2 weeks
Trunk extension test	Participants will be asked to lie prone out of the bed from the upper part of the iliac crista with their hips and knees in full extension. The time will maintain the horizontal position with their arms in the inverted T position will be measured with a stopwatch and recorded	up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance assessment	Balance will be evaluated with the HUR BTG4 Balance Master System® (HUR International, Finland) on stable and unstable platform.	up to 2 weeks
Functional assessment	Function will be assessed with the Fibromyalgia Impact Questionnaire (FIQ). The FIQ consists of 10 items. The first item includes daily activity questions scored on a Likert scale from 0 to 3 (always able to do - never able to do). The 10 items are added together to calculate the total score	up to 2 weeks
Demographic assessment	Age, height, weight, occupation, medication, smoking will be asked and recorded from the patients	up to 2 weeks

Collaborators and Investigators

• Sponsor: Firat University

Study record dates

Study Major Dates

• Study Start (Estimated): September 17, 2024
• Primary Completion (Estimated): October 14, 2024
• Study Completion (Estimated): October 20, 2024

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Fibromyalgia; balance; core endurance test
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 2022/ 11- 24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No