Fibromyalgia Clinical Trial
Official title:
Effectiveness of High-intensity Interval Training Combined With Resistance Training in Patients With Fibromyalgia
Verified date | March 2020 |
Source | Hitit University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Fibromyalgia is a common rheumatic disease characterized by widespread musculoskeletal pain, tenderness, fatigue, sleep disorders, cognitive and somatic complaints. Patients often suffer many somatic and psychological symptoms which contributes negative effect on the health- related quality of life, physical performance and physical activity. Recently, the European League Against Rheumatism presented evidence based recommendations for the management of the fibromyalgia. Accordingly, prompt diagnosis and patient education is required for optimal management. A graduated approach with the aim of improving health-related quality of life should be followed. It should focus first on non-pharmacological modalities and the only "strong for" evidence-based recommendation was the use of aerobic and strengthening exercise. Aerobic exercise with moderate intensity (60 to 70% of age-adjusted predicted maximum heart rate (maxHR)) with a frequency of two or three times per week for at least 4 to 6 weeks for a reduction of symptoms is recommended in the management of fibromyalgia. Low-intensity aerobic exercise (<50 % maxHR) is founded ineffective. In recent years, high intensity interval training (HIIT) is used as popular instead of moderate intensity continuous exercise training (MICT) in cardiac rehabilitation units. It is found superior to moderate intensity exercise in improving cardiovascular fitness as increases maximal oxygen consumption (VO2max). The investigators hypothesis is that 6 weeks of five weekly sessions of HIIT will show superior effect reducing the impact of fibromyalgia and improving pain degree, functional capacity and health-related quality of life in women with fibromyalgia compared to MICT.
Status | Completed |
Enrollment | 55 |
Est. completion date | February 17, 2020 |
Est. primary completion date | February 17, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Subjects diagnosed according to the American College of Rheumatology 2016 diagnostic criteria for fibromyalgia. Exclusion Criteria: - History of comorbid inflammatory rheumatic/ connective tissue diseases - History of cardiovascular or musculoskeletal problems that could prevent them to participate in an exercise program. |
Country | Name | City | State |
---|---|---|---|
Turkey | Tugba Atan | Corum |
Lead Sponsor | Collaborator |
---|---|
Hitit University |
Turkey,
Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Häuser W, Fluß E, Choy E, Kosek E, Amris K, Branco J, Dincer F, Leino-Arjas P, Longley K, McCarthy GM, Makri S, Perrot S, Sarzi-Puttini P, Taylor A, Jones GT. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2017 Feb;76(2):318-328. doi: 10.1136/annrheumdis-2016-209724. Epub 2016 Jul 4. Review. — View Citation
Rognmo Ø, Hetland E, Helgerud J, Hoff J, Slørdahl SA. High intensity aerobic interval exercise is superior to moderate intensity exercise for increasing aerobic capacity in patients with coronary artery disease. Eur J Cardiovasc Prev Rehabil. 2004 Jun;11(3):216-22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fibromyalgia impact questionnaire | The FIQ was designed to measure the health status of patients with fibromyalgia. | 6 weeks | |
Secondary | Visual analogue scale | Pain intensity was measured with visual analogue scale (0-10mm) which is used to measure musculoskeletal pain with very good reliability and validity. | 6 weeks | |
Secondary | Short- form health survey 36 | Short- form health survey 36 contains 36 items which are used to evaluate the quality of life of patients with chronic pain. It measures eight different domains that address physical functioning, physical role limitation, pain, general health, vitality, social functioning, emotional role limitation and mental health. The score of each domain ranges from 0 (worse quality of life) to 100 (best quality of life). | 6 weeks | |
Secondary | Cardiorespiratory fitness | A symptom-limited maximal cardiopulmonary exercise test performed on a cycle ergometer at baseline and following six-week exercise intervention to measure maximal oxygen consumption (VO2maximum) (ml/ kg/min). | 6 weeks |
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