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

Sponsor
Uskudar University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06006494
Collaborator
(none)
60
3
3.9

Study Details

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
  • Other: aerobic
  • Other: resistant
  • Other: yoga
N/A

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
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Aerobic exercises, resistant exercises and yogaAerobic 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
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 10, 2023
Anticipated Study Completion Date :
Dec 30, 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 [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 [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

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

No locations specified.

Sponsors and Collaborators

  • Uskudar University

Investigators

  • Study Chair: Hilal ATASOY, Uskudar University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. Öğr. Üyesi Ömer Şevgin, Asst.Prof.Dr., Uskudar University
ClinicalTrials.gov Identifier:
NCT06006494
Other Study ID Numbers:
  • Uskudar53
First Posted:
Aug 23, 2023
Last Update Posted:
Aug 23, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
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, Asst.Prof.Dr., Uskudar University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2023