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

September 28, 2024 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Uskudar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uskudar University

Investigators

  • Study Chair: Hilal ATASOY, Uskudar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

December 10, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 28, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uskudar53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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