High-intensity Interval Training in Patients With Fibromyalgia

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Pharmacotherapy is only recommended for severe pain and sleep disturbances. 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). While the moderate intensity continuous aerobic exercise program lasts 30 to 60 minutes, HIIT contains 4-6 cycles of 1-4 minutes with a maximum effort and lasts approximately 20 minutes in total. Therefore, another advantage of HIIT is the need for a shorter time to achieve similar or greater effects compared to MICT. The investigatorshypothesis 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. Therefore, the aim of this study is to assess the effects of HIIT versus MICT on pain, functional capacity and quality of life in women with fibromyalgia.

Official Title
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Effectiveness of High-intensity Interval Training Combined With Resistance Training in Patients With Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: High-intensity interval training
* Behavioral: Moderate-intensity continuous training
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-intensity interval training<br>Participants in this group will perform a 20-25 minutes of aerobic exercise with a maximum capacity of 3-4 minutes (HRmax 80-95%) and active recovery for 3-4 minutes (HRmax 30-50%), five exercise sessions per week for 6 weeks. | Behavioral: High-intensity interval training<br>* Participants in this group will perform a 20-25 minutes of aerobic exercise with a maximum capacity of 3-4 minutes (HRmax 80-95%) and active recovery for 3-4 minutes (HRmax 30-50%), five exercise sessions per week for 6 weeks.<br>|
| Active Comparator: Moderate-intensity continuous training<br>Participants in this group will perform a 30-45 minute ergometric cycling exercise at 65-70% of the measured maximum heart rate (HRmax), five exercise sessions per week for 6 weeks. | Behavioral: Moderate-intensity continuous training<br>* Participants in this group will perform a 30-45 minute ergometric cycling exercise at 65-70% of the measured maximum heart rate (HRmax), five exercise sessions per week for 6 weeks.<br>|
| Other: Control<br>Usual care control group | Behavioral: Control<br>* Usual care control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia impact questionnaire | The FIQ was designed to measure the health status of patients with fibromyalgia. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibromyalgia, functional capacity, aerobic exercise