Comparison of the Effectiveness of Yoga and Exercise in Female Patients With Fibromyalgia Syndrome

Fibromyalgia Clinical Trial

Official title:

Comparison of the Effectiveness of Yoga and Exercise in Female Patients With Fibromyalgia Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06006494
• Other study ID #: Uskudar53
• Status: Completed
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: December 2023
• Source: Uskudar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, yoga, aerobic exercise, resistance exercise training in female individuals with fibromyalgia syndrome; It was aimed to compare their effectiveness on fatigue, quality of life and pain.

Description:

The study was planned as a randomized controlled study. Participants will be divided into 3 groups by simple randomization method. groups will be named as aerobic, yoga and resistance exercise groups. 12-week exercise protocols will be applied to all participants. Participants before and after treatment; The Fibromyalgia Impact Questionnaire, the McGill Pain Questionnaire for pain assessment, the Chalder Fatigue Scale to assess their fatigue level, will be filled in by the participants before and after the study. The data obtained will be statistically analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 15, 2023
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Between the ages of 18-45
• Be woman
• Being diagnosed with fibromyalgia

Exclusion Criteria:

• Receiving pharmacological treatment
• Having had a surgical operation in the last 6 months
• Being pregnant
• Having a musculoskeletal injury

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• aerobic
We can think of aerobic exercise as a low-intensity long-term activity using large muscle groups (between 60-80% of maximal heart rate). For example; includes activities such as walking, cycling, jogging, aerobic dancing, swimming. An average of 50 minutes of exercise per day will be required, 3 days a week.
• resistant
Resistance exercises are the whole of the exercises in which effort is made against the weight and the weight is lifted. Exercises with therabands, dumbbells or body weight will be given. The exercises will be done 2 days a week for an average of 30-40 minutes.
• yoga
Yoga is basically breathing exercises, warm-up exercises, relaxation, It is a session consisting of movements and relaxation exercises.movements are performed by standing in a fixed posture for 15 seconds to 2 minutes in a certain posture, they are postures for both strengthening, stretching and balance. Yoga practice will be done 2 days a week for an average of 40 minutes.

Locations

Country	Name	City	State
Turkey	Uskudar university	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Uskudar University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Bidonde J, Busch AJ, Schachter CL, Overend TJ, Kim SY, Goes SM, Boden C, Foulds HJ. Aerobic exercise training for adults with fibromyalgia. Cochrane Database Syst Rev. 2017 Jun 21;6(6):CD012700. doi: 10.1002/14651858.CD012700. — View Citation

Busch AJ, Webber SC, Brachaniec M, Bidonde J, Bello-Haas VD, Danyliw AD, Overend TJ, Richards RS, Sawant A, Schachter CL. Exercise therapy for fibromyalgia. Curr Pain Headache Rep. 2011 Oct;15(5):358-67. doi: 10.1007/s11916-011-0214-2. — View Citation

Busch AJ, Webber SC, Richards RS, Bidonde J, Schachter CL, Schafer LA, Danyliw A, Sawant A, Dal Bello-Haas V, Rader T, Overend TJ. Resistance exercise training for fibromyalgia. Cochrane Database Syst Rev. 2013 Dec 20;2013(12):CD010884. doi: 10.1002/14651858.CD010884. — View Citation

Sosa-Reina MD, Nunez-Nagy S, Gallego-Izquierdo T, Pecos-Martin D, Monserrat J, Alvarez-Mon M. Effectiveness of Therapeutic Exercise in Fibromyalgia Syndrome: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Biomed Res Int. 2017;2017:2356346. doi: 10.1155/2017/2356346. Epub 2017 Sep 20. — View Citation

Verma A, Shete SU, Doddoli G. Yoga therapy for fibromyalgia syndrome: A case report. J Family Med Prim Care. 2020 Jan 28;9(1):435-438. doi: 10.4103/jfmpc.jfmpc_816_19. eCollection 2020 Jan. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia Impact Questionnaire	It assesses the impact of fibromyalgia on the patient's health and functional abilities.; High scores indicate that the disease affects the person more. The total score can be between 0-80. A score of 80 indicates high influence.	14 weeks
Primary	Chalder Fatigue Scale	It is an easy, fast and useful scale that evaluates the fatigue felt by the individual during the last 1 month by self-report. High scores indicate that the severity of fatigue is high.	14 weeks