FibromyalgiaNCT06006494
Comparison of the Effectiveness of Yoga and Exercise in Female Patients With Fibromyalgia Syndrome
A study testing aerobic, resistant and yoga in people with Fibromyalgia, run by Uskudar University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- aerobic, resistant and yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Between the ages of 18-45
- Be woman
- Being diagnosed with fibromyalgia
Who cannot join
- Receiving pharmacological treatment
- Having had a surgical operation in the last 6 months
- Being pregnant
- Having a musculoskeletal injury
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- aerobic, resistant, yoga
- Keywords
- women, sleep, tiredness
- Medical subject headings
- Fibromyalgia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobicOther
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.
resistantOther
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.
yogaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| aerobic group | Active comparator | only a separate aerobic exercise will be given Receives: Other: aerobic |
| resistant group | Experimental | aerobic and resistance exercises will be given Receives: Other: aerobic; Other: resistant |
| yoga group | Experimental | aerobic exercises will be given and yoga will be done Receives: Other: aerobic; Other: yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Sep 2023
- Primary completion10 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Aerobic exercises, resistant exercises and yoga
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
- Investigators
- Hilal ATASOY, Study chair, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006494
- Sponsor's protocol ID
- Uskudar53
- Status last verified
- Sep 2024
- First submitted
- 17 Aug 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29291206Busch 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.
PubMed 21725900Bidonde 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.
PubMed 28636204Busch 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.
PubMed 24362925Verma 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.
PubMed 32110633Sevgin O, Bugday B, Aydogan Baykara R, Gunendi G, Akkurt B, Atasoy H, Dikmen Hosbas B, Akkurt MF, Karamancioglu B. Efficacy of different exercises in women with fibromyalgia syndrome: a randomised controlled trial. Clin Exp Rheumatol. 2025 Jun;43(6):1010-1018. doi: 10.55563/clinexprheumatol/uol8so. Epub 2025 Feb 12.
PubMed 39946182
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Yoga and Exercise in Female Patients With Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT06006494
- Acronym / sponsor ID
- Uskudar53
- Conditions
- Fibromyalgia
- Keywords
- women, sleep, tiredness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Aerobic exercises, resistant exercises and yoga
| Arm | Type | Receives |
|---|---|---|
| aerobic group | Active comparator | Other: aerobiconly a separate aerobic exercise will be given |
| resistant group | Experimental | Other: aerobic, Other: resistantaerobic and resistance exercises will be given |
| yoga group | Experimental | Other: aerobic, Other: yogaaerobic exercises will be given and yoga will be done |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between the ages of 18-45
- Be woman
- Being diagnosed with fibromyalgia
Key exclusion criteria (4 listed)
- Receiving pharmacological treatment
- Having had a surgical operation in the last 6 months
- Being pregnant
- Having a musculoskeletal injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobicWe 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 | aerobic group, resistant group, yoga group |
| resistantResistance 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. | Other | resistant group |
| yogaYoga 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. | Other | yoga group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 29291206Sosa-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.
- Background: PubMed 21725900Busch 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.
- Background: PubMed 28636204Bidonde 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.
- Background: PubMed 24362925Busch 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.
- Background: PubMed 32110633Verma 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.
- Derived from this study: PubMed 39946182Sevgin O, Bugday B, Aydogan Baykara R, Gunendi G, Akkurt B, Atasoy H, Dikmen Hosbas B, Akkurt MF, Karamancioglu B. Efficacy of different exercises in women with fibromyalgia syndrome: a randomised controlled trial. Clin Exp Rheumatol. 2025 Jun;43(6):1010-1018. doi: 10.55563/clinexprheumatol/uol8so. Epub 2025 Feb 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilal ATASOY study chair
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic, resistant and yoga in people with Fibromyalgia, run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06006494, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.