Clinical trial NCT04835077: Aerobic Exercises and Postural Stabilization Exercises in Fibromyalgia Syndrome
Official title: Comparison of the Effectiveness of Structured Aerobic Exercises and Postural Stabilization Exercises in Patients With Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia Syndrome
Physiotherapy
Rehabilitation
Keywords: Aerobic Exercise
Postural Control
Fibromyalgia
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Study
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Being in the age range of 25-60 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

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: change from baseline at 8 weeks
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: change from baseline at 8 weeks
Other outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: change from baseline at 8 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: change from baseline at 8 weeks
measure: Fatigue Severity Scale (FSS)
timeFrame: change from baseline at 8 weeks
measure: 2 Minute Walking Test
timeFrame: change from baseline at 8 weeks
measure: Short Form Health Survey (SF-36)
timeFrame: change from baseline at 8 weeks
measure: International Physical Activity Questionnaire Short Form (IPAQ Short Form)
timeFrame: change from baseline at 8 weeks
measure: PostureZone Mobile Application
timeFrame: change from baseline at 8 weeks
measure: Plank position time
timeFrame: change from baseline at 8 weeks
Locations:
city: Istanbul
country: Turkey
facility: Mustafa Yilmaz
state: Büyükçekmece
Study officials:
affiliation: MSc Physiotherapist
name: MUSTAFA YILMAZ
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Walker J. Fibromyalgia: clinical features, diagnosis and management. Nurs Stand. 2016 Sep 28;31(5):51-63. doi: 10.7748/ns.2016.e10550.
citation: 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.
citation: Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266.