Comparison of the Effects of Balance-proprioception and Aerobic Exercises on Functional Status and Strength Parameters in Patients With Fibromyalgia.

Fibromyalgia Syndrome Clinical Trial

— FMS  

Official title:

Comparison of the Effects of Balance-proprioception and Aerobic Exercises on Functional Status, Pain and Strength Parameters in Patients With Fibromyalgia Syndrome (FMS).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04437524
• Other study ID #: 196481654
• Status: Completed
• Phase: N/A
• Start date: August 24, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: December 2020
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, it was aimed to examine the effects of aerobic exercise and balance-proprioception exercises on pain, functionality and strength parameters of fibromyalgia patients and to compare the two exercise types.

Description:

In the study planned to evaluate the effect of aerobic and balance-proprioception exercises on the symptoms of the disease and the superiority of the two exercise models in patients with fibromyalgia syndrom (FMS), 62 women who meet the inclusion criteria will be randomly divided into two groups. Aerobic exercise group (n = 26) and balance-proprioception exercise group (n = 26) will be applied for 3 weeks a week, 6 days a week under the supervision of a physiotherapist in the exercise laboratory of the Istanbul Medical Faculty Sports Medicine Department. Pain (VAS), functional status (FİQ) and knee extension muscle strength (Cybex isokinetic dynamometer) will be evaluated before and after the program. Cognitive status will be evaluated with standardized Mini Mental Test only before the program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Being between the ages of 18 and 60,
• Symptoms lasting longer than 3 months,
• According to the 2013 ACR criteria, the Pain Settlement Score (PLI) is =17,
• According to the 2013 ACR criteria, the Symptomatic Impact Scoring (SIQR) is =21,
• Acceptance of treatment that will continue 3 days a week for 6 weeks,
• The possibility of any change in medical treatment due to FMS during the study is not foreseen.

Exclusion Criteria:

• Known central or peripheral nervous system disease, progressive neurological damage,
• Any serious cardiovascular pathology,
• Sense, loss of sense of position, unhealed fracture or a surgical wound,
• Presence of uncontrolled hypertension,
• Failure to understand or perform simple commands.

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia Syndrome
• Myofascial Pain Syndromes
• Syndrome

Intervention

Other:
• therapeutic exercises
Treatment that will continue 3 days a week for 6 weeks in female patients with fibromyalgia.

Locations

Country	Name	City	State
Turkey	Istanbul Faculty of Medicine, Department of Sports Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia Impact Questionnaire (FIQ)	In order to evaluate the functional status in patients with FMS, FIQ Burchardt et al. It is a specific scale developed by. FIQ consists of 10 items. Calculation is made so that the upper limit of each item is 10 points. The maximum score that can be reached is 100. A high total score indicates that the person is more affected by the disease.	6 weeks
Primary	Pain (Visual Analogue Scale)	Visual Analaog Scale is used to measure the severity of pain in patients. The patient is told that there is no "0" pain on the 10 cm ruler drawn on paper, "10" is the most experienced pain, and the patient is asked to mark on the ruler according to the severity of the pain he/she feels. The distance of the marked point from zero is recorded as the Visual Analogue Scale score in cm.	6 weeks
Primary	Muscle Strength Evaluation	The CSMI Humac Norm 2015 isokinetic dynamometer will be used to evaluate muscle strength.	6 weeks