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High-intensity Interval Training in Patients With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
High-intensity interval training
Moderate-intensity continuous training
Control
Sponsored by
Hitit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, functional capacity, aerobic exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Tuğba Atan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

High-intensity interval training

Moderate-intensity continuous training

Control

Arm 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.

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.

Usual care control group

Outcomes

Primary Outcome Measures

Fibromyalgia impact questionnaire
The FIQ was designed to measure the health status of patients with fibromyalgia.

Secondary Outcome Measures

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.
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).
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).

Full Information

First Posted
April 22, 2019
Last Updated
March 15, 2020
Sponsor
Hitit University
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1. Study Identification

Unique Protocol Identification Number
NCT03924960
Brief Title
High-intensity Interval Training in Patients With Fibromyalgia
Official Title
Effectiveness of High-intensity Interval Training Combined With Resistance Training in Patients With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 22, 2019 (Actual)
Primary Completion Date
February 17, 2020 (Actual)
Study Completion Date
February 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hitit University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, functional capacity, aerobic exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-intensity interval training
Arm Type
Experimental
Arm 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 Title
Moderate-intensity continuous training
Arm Type
Active Comparator
Arm 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 Title
Control
Arm Type
Other
Arm Description
Usual care control group
Intervention Type
Behavioral
Intervention Name(s)
High-intensity interval training
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Moderate-intensity continuous training
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Usual care control group
Primary Outcome Measure Information:
Title
Fibromyalgia impact questionnaire
Description
The FIQ was designed to measure the health status of patients with fibromyalgia.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Visual analogue scale
Description
Pain intensity was measured with visual analogue scale (0-10mm) which is used to measure musculoskeletal pain with very good reliability and validity.
Time Frame
6 weeks
Title
Short- form health survey 36
Description
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).
Time Frame
6 weeks
Title
Cardiorespiratory fitness
Description
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).
Time Frame
6 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female sex
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Tuğba Atan
City
Corum
ZIP/Postal Code
19100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27377815
Citation
Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Hauser 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.
Results Reference
background
PubMed Identifier
15179103
Citation
Rognmo O, Hetland E, Helgerud J, Hoff J, Slordahl 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. doi: 10.1097/01.hjr.0000131677.96762.0c.
Results Reference
background
PubMed Identifier
32585169
Citation
Atan T, Karavelioglu Y. Effectiveness of High-Intensity Interval Training vs Moderate-Intensity Continuous Training in Patients With Fibromyalgia: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Nov;101(11):1865-1876. doi: 10.1016/j.apmr.2020.05.022. Epub 2020 Jun 22.
Results Reference
derived

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High-intensity Interval Training in Patients With Fibromyalgia

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