Aerobic Exercises and Postural Stabilization Exercises in Fibromyalgia Syndrome

Overview

Fibromyalgia Syndrome (FMS) is a chronic rheumatic disease characterized by a wide range of symptoms such as widespread muscle pain, fatigue, sleep disturbances, anxiety-depression, impaired balance, falling risk, poor physical condition, cognitive dysfunction, and irritable bowel syndrome. The aim of the study; It is a comparison of the effectiveness of aerobic exercises and postural stabilization exercises that are structured to reduce the pain severity, fatigue, sleep problems and anxiety-depression levels of patients who are being followed up with a diagnosis of FMS, and to increase the duration of physical activity and quality of life.

Full Title of Study: “Comparison of the Effectiveness of Structured Aerobic Exercises and Postural Stabilization Exercises in Patients With Fibromyalgia Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 1, 2022

Interventions

  • Other: aerobic exercise
    • Structured aerobic exercises (Each session will consist of 50 minutes and will be divided into three parts: 5 minutes of warm-up exercises, 40 minutes of aerobic exercises, 5 minutes of cool down exercises) will be taught in the first session.
  • Other: postural stabilization exercises
    • Structured postural stabilization exercises (strengthening exercises, balance-coordination exercises, flexibility exercises) will be taught in the first session.

Arms, Groups and Cohorts

  • Experimental: Structured Aerobic Exercises
    • Following the training on aerobic exercise content and effectiveness; First Week; participants 5 minutes warm-up, 20 minutes of aerobic exercise with 60-70% of maximum heart rate, and 5 minutes of cool down. In the following weeks, the aerobic exercise duration of all participants will be increased by 5 minutes compared to the previous week. The duration of the sessions in the 7th and 8th weeks will progressively progress to 40 minutes and the intensity to 75-80% of the maximum heart rate.
  • Experimental: Postural Stabilization Exercises
    • Exercises; It will consist of postural exercises to be done in prone, supine, side lying, crawling, sitting and standing positions. All exercises will be done in 2 sets per day, the number of repetitions will be determined individually and progressed. Breathing exercises Four-way stretching and strengthening of the neck muscles Shoulder girdle stretching and strengthening exercises Hip flexors, hamstring, itb, lumbar extensor stretching and strengthening Lying down exercises in the crawling position Shuttle movement Plank movement Toe taps Bridging Straight leg lift Straight leg raises in side-lying Prone knee flexion
  • No Intervention: Control
    • The individuals without any treatment will continue their normal lives and will be included in the study as a control group. Exercise will be given after 8 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Fibromyalgia Impact Questionnaire (FIQ)
    • Time Frame: change from baseline at 8 weeks
    • This scale; It measures 10 different characteristics: physical function, feeling unwell, not going to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. Except for the sense of well-being, lower scores indicate improvement or less affected by the disease. FIQ is filled by the patient. The maximum possible score for each subtitle is 10. Thus, the total maximum score is 100. While the average FM patient gets 50 points, more severely affected FM patients usually score above 70.

Secondary Measures

  • Visual Analogue Scale (VAS)
    • Time Frame: change from baseline at 8 weeks
    • VAS; It is a scale that provides a one-dimensional measurement of pain intensity in different adult populations. It usually consists of a 10 cm long horizontal (HVAS) or vertical (VVAS) line. In measuring the severity of pain; A score of 0 is defined as no pain, a score of 10 as worst pain possible or worst imaginable pain. Although the period of time when pain is questioned varies, the most common time for the patient’s pain is the current pain or the pain experienced in the last 24 hours.

Participating in This Clinical Trial

Inclusion Criteria

  • Being in the age range of 18-60 According to the 2013 American College of Rheumatology (ACR) diagnostic criteria, the Pain Placement Score (AES) is 17 and the Symptomatic Effect Score (SES) is ≥21. – FMS symptoms persist for more than 3 months – Ability to adapt to exercise – Having the ability to use the necessary devices for web-based training Exclusion Criteria:

  • Any disease that may hinder exercise – Finding cardiological problems for aerobic exercises – Presence of loss of sense and sense of position – Presence of an unhealed fracture or surgical wound Patients with mental / psychotic disorders

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Istanbul University-Cerrahpasa
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mustafa Yilmaz, MSc Physiotherapsit – Istanbul University-Cerrahpasa
  • Overall Official(s)
    • MUSTAFA YILMAZ, Principal Investigator, MSc Physiotherapist
  • Overall Contact(s)
    • MUSTAFA YILMAZ, +905445455424, fzt.mustafayilmaz@gmail.com

References

Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

Walker J. Fibromyalgia: clinical features, diagnosis and management. Nurs Stand. 2016 Sep 28;31(5):51-63. doi: 10.7748/ns.2016.e10550.

Vincent A, Lahr BD, Wolfe F, Clauw DJ, Whipple MO, Oh TH, Barton DL, St Sauver J. Prevalence of fibromyalgia: a population-based study in Olmsted County, Minnesota, utilizing the Rochester Epidemiology Project. Arthritis Care Res (Hoboken). 2013 May;65(5):786-92. doi: 10.1002/acr.21896.

Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266. Review.

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