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High-intensity Interval Training in Patients With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT03924960
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Tuğba Atan, 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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: High-intensity interval training Behavioral: Moderate-intensity continuous training Behavioral: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of High-intensity Interval Training Combined With Resistance Training in Patients With Fibromyalgia
Actual Study Start Date : April 22, 2019
Estimated Primary Completion Date : October 22, 2019
Estimated Study Completion Date : November 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: High-intensity interval training
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
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.

Active Comparator: Moderate-intensity continuous training
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
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.

Control
Usual care control group
Behavioral: Control
Usual care control group




Primary Outcome Measures :
  1. Fibromyalgia impact questionnaire [ Time Frame: 6 weeks ]
    The FIQ was designed to measure the health status of patients with fibromyalgia.


Secondary Outcome Measures :
  1. Visual analogue scale [ Time Frame: 6 weeks ]
    Pain intensity was measured with visual analogue scale (0-10mm) which is used to measure musculoskeletal pain with very good reliability and validity.

  2. Short- form health survey 36 [ Time Frame: 6 weeks ]
    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).

  3. Cardiorespiratory fitness [ Time Frame: 6 weeks ]
    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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female sex
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924960


Locations
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Turkey
Tuğba Atan Recruiting
Corum, Turkey, 19100
Contact: Tuğba Atan, Assoc. Prof.    +905556679857    tubaatan@gmail.com   
Sponsors and Collaborators
Hitit University

Publications:
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Responsible Party: Tuğba Atan, Assoc. Prof., Hitit University
ClinicalTrials.gov Identifier: NCT03924960     History of Changes
Other Study ID Numbers: 19-KAEK-023
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tuğba Atan, Hitit University:
fibromyalgia
functional capacity
aerobic exercise

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases