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

Primary Purpose

Fibromyalgia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
aerobic
resistant
yoga
Sponsored by
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring women, sleep, tiredness

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Uskudar universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

aerobic group

resistant group

yoga group

Arm Description

only a separate aerobic exercise will be given

aerobic and resistance exercises will be given

aerobic exercises will be given and yoga will be done

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 17, 2023
Last Updated
September 1, 2023
Sponsor
Uskudar University
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1. Study Identification

Unique Protocol Identification Number
NCT06006494
Brief Title
Comparison of the Effectiveness of Yoga and Exercise in Female Patients With Fibromyalgia Syndrome
Official Title
Comparison of the Effectiveness of Yoga and Exercise in Female Patients With Fibromyalgia Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
December 10, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar 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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
women, sleep, tiredness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Aerobic exercises, resistant exercises and yoga
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aerobic group
Arm Type
Active Comparator
Arm Description
only a separate aerobic exercise will be given
Arm Title
resistant group
Arm Type
Experimental
Arm Description
aerobic and resistance exercises will be given
Arm Title
yoga group
Arm Type
Experimental
Arm Description
aerobic exercises will be given and yoga will be done
Intervention Type
Other
Intervention Name(s)
aerobic
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
resistant
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
yoga
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire
Description
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.
Time Frame
14 weeks
Title
Chalder Fatigue Scale
Description
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.
Time Frame
14 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ömer şevgin
Phone
+90506 978 75 35
Email
omer.sevgin@uskudar.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilal ATASOY
Organizational Affiliation
Uskudar University
Official's Role
Study Chair
Facility Information:
Facility Name
Uskudar university
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ömer Şevgin
Email
omer.sevgin@uskudar.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29291206
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.
Results Reference
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PubMed Identifier
21725900
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.
Results Reference
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PubMed Identifier
28636204
Citation
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.
Results Reference
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PubMed Identifier
24362925
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.
Results Reference
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PubMed Identifier
32110633
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.
Results Reference
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Comparison of the Effectiveness of Yoga and Exercise in Female Patients With Fibromyalgia Syndrome

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