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NCT Number: NCT04437524

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

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.

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Key information

Conditions

Fibromyalgia Syndrome Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

İstanbul Faculty of Medicine, Department of Sports Medicine

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

therapeutic exercises

Other

Treatment that will continue 3 days a week for 6 weeks in female patients with fibromyalgia.

Primary outcomes

  1. Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: 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.

  2. Pain (Visual Analogue Scale)

    Time frame: 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.

  3. Muscle Strength Evaluation

    Time frame: 6 weeks

    The CSMI Humac Norm 2015 isokinetic dynamometer will be used to evaluate muscle strength.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Acronym: FMS

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 18, 2020
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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