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

Not Applicable

Completed

• Conditions: Fibromyalgia Syndrome
• Interventions: Other: therapeutic exercises

• Registration Number: NCT04437524
• Lead Sponsor: Istanbul University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-18
• Study Start: 2020-08-24
• Primary Completion: 2020-10-30
• Study Completion: 2020-11-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-08
• Last Update Posted: 2020-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
balance-proprioception exercises group	therapeutic exercises	balance-proprioception exercises group
aerobic exercises group	therapeutic exercises	aerobic exercises group

Primary Outcome Measures

Name	Time	Method
Fibromyalgia Impact Questionnaire (FIQ)	6 weeks	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.
Pain (Visual Analogue Scale)	6 weeks	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.
Muscle Strength Evaluation	6 weeks	The CSMI Humac Norm 2015 isokinetic dynamometer will be used to evaluate muscle strength.

Trial Locations

Locations (1)

İstanbul Faculty of Medicine, Department of Sports Medicine; 🇹🇷 Istanbul, Turkey