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

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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia Syndrome
• Intervention / Treatment: Other: therapeutic exercises

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • İstanbul Faculty of Medicine, Department of Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: balance-proprioception exercises group	Other: therapeutic exercises; Treatment that will continue 3 days a week for 6 weeks in female patients with fibromyalgia.
Active Comparator: aerobic exercises group	Other: therapeutic exercises; Treatment that will continue 3 days a week for 6 weeks in female patients with fibromyalgia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Muscle Strength Evaluation	The CSMI Humac Norm 2015 isokinetic dynamometer will be used to evaluate muscle strength.	6 weeks

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Study Director: Gökhan Metin, Professor, İstanbul Univesity, İstanbul Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2020
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 8, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Fibromyalgia, aerobic exercise, balance, proprioception, pain, strength
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 196481654

Drug and device information, study documents

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