NCT03924960

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

April 22, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

April 22, 2019

Last Update Submit

March 15, 2020

Conditions

Fibromyalgia

Keywords

fibromyalgiafunctional capacityaerobic exercise

Outcome Measures

Primary Outcomes (1)

  • Fibromyalgia impact questionnaire

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

    6 weeks

Secondary Outcomes (3)

  • Visual analogue scale

    6 weeks

  • Short- form health survey 36

    6 weeks

  • Cardiorespiratory fitness

    6 weeks

Study Arms (3)

High-intensity interval training

EXPERIMENTAL

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

Moderate-intensity continuous training

ACTIVE COMPARATOR

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

Control

OTHER

Usual care control group

Behavioral: Control

Interventions

High-intensity interval trainingBEHAVIORAL

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.

High-intensity interval training
Moderate-intensity continuous trainingBEHAVIORAL

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.

Moderate-intensity continuous training
ControlBEHAVIORAL

Usual care control group

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale sex
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects diagnosed according to the American College of Rheumatology 2016 diagnostic criteria for fibromyalgia.

You may not qualify if:

  • History of comorbid inflammatory rheumatic/ connective tissue diseases
  • History of cardiovascular or musculoskeletal problems that could prevent them to participate in an exercise program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuğba Atan

Çorum, 19100, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 27377815BACKGROUND

  • 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.

    PMID: 15179103BACKGROUND

  • 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.

    PMID: 32585169DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

April 22, 2019

First Posted

April 23, 2019

Study Start

April 22, 2019

Primary Completion

February 17, 2020

Study Completion

February 17, 2020

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)