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

• ClinicalTrials.gov Identifier: NCT06006494
• Recruitment Status: Completed
• First Posted: August 23, 2023
• Last Update Posted: December 22, 2023
• Sponsor: Uskudar University
• Information provided by (Responsible Party): Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Other: aerobic; Other: resistant; Other: yoga	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Aerobic exercises, resistant exercises and yoga
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of the Effectiveness of Yoga and Exercise in Female Patients With Fibromyalgia Syndrome
• Actual Study Start Date: September 1, 2023
• Actual Primary Completion Date: December 10, 2023
• Actual Study Completion Date: December 15, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: aerobic group; only a separate aerobic exercise will be given	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.
Experimental: resistant group; aerobic and resistance exercises will be given	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.; Other: 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.
Experimental: yoga group; aerobic exercises will be given and yoga will be done	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.; Other: 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.

Outcome Measures

Primary Outcome Measures :

1. Fibromyalgia Impact Questionnaire [ Time Frame: 14 weeks ]

   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.

2. Chalder Fatigue Scale [ Time Frame: 14 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Turkey

Uskudar university

Istanbul, Turkey

Sponsors and Collaborators

Uskudar University

Investigators

• Study Chair: Hilal ATASOY; Uskudar University

More Information

Publications:

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.

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.

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.

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.

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.

• Responsible Party: Dr. Öğr. Üyesi Ömer Şevgin, Asst.Prof.Dr., Uskudar University
• ClinicalTrials.gov Identifier: NCT06006494
• Other Study ID Numbers: Uskudar53
• First Posted: August 23, 2023
• Last Update Posted: December 22, 2023
• Last Verified: December 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University:

women; sleep; tiredness

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases