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

High-intensity Interval Training in Patients With Fibromyalgia

Sponsors

Lead sponsor: Hitit University

Source Hitit University
Brief Summary

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

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.

Overall Status Completed
Start Date April 22, 2019
Completion Date February 17, 2020
Primary Completion Date February 17, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Fibromyalgia impact questionnaire 6 weeks
Secondary Outcome
Measure Time Frame
Visual analogue scale 6 weeks
Short- form health survey 36 6 weeks
Cardiorespiratory fitness 6 weeks
Enrollment 55
Condition
Intervention

Intervention type: Behavioral

Intervention name: High-intensity interval training

Description: 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.

Arm group label: High-intensity interval training

Intervention type: Behavioral

Intervention name: Moderate-intensity continuous training

Description: 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.

Arm group label: Moderate-intensity continuous training

Intervention type: Behavioral

Intervention name: Control

Description: Usual care control group

Arm group label: Control

Eligibility

Criteria:

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.

Gender: Female

Gender based: Yes

Gender description: female sex

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Location
facility Tuğba Atan
Location Countries

Turkey

Verification Date

March 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Hitit University

Investigator full name: Tuğba Atan

Investigator title: Assoc. Prof.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: High-intensity interval training

Arm group type: Experimental

Description: 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.

Arm group label: Moderate-intensity continuous training

Arm group type: Active Comparator

Description: 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.

Arm group label: Control

Arm group type: Other

Description: Usual care control group

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Investigator)

Source: ClinicalTrials.gov