Investigation of Core Endurance in Fibromyalgia

NCT06604936 | Recruiting

• 1 other identifier: 2022/ 11- 24
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Fibromyalgia

Keywords

Fibromyalgia; core endurance test; balance

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Balance assessment

  up to 2 weeks

• Functional assessment

  up to 2 weeks

• Demographic assessment

  up to 2 weeks

Study Arms (2)

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

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

Interventions

Fibromyalgia group OTHER

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.

Fibromyalgia group

Healthy group OTHER

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.

Healthy group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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 had dysfunction that can prevent physical activity

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Songul Baglan Yentur

Elâzığ, 23100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Physiotherapy and Rehabilitation Department

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: September 20, 2024
• Study Start: September 17, 2024
• Primary Completion: October 14, 2024
• Study Completion: October 20, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)