Fibromyalgia SyndromeFMSNCT04437524
Comparison of the Effects of Balance-proprioception and Aerobic Exercises on Functional Status and Strength Parameters in Patients With Fibromyalgia.
A study testing therapeutic exercises in people with Fibromyalgia Syndrome, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to examine the effects of aerobic exercise and balance-proprioception exercises on pain, functionality and strength parameters of fibromyalgia patients and to compare the two exercise types. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- therapeutic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Aug 2020to 30 Nov 2020
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being between the ages of 18 and 60,
- Symptoms lasting longer than 3 months,
- According to the 2013 ACR criteria, the Pain Settlement Score (PLI) is ≥17,
- According to the 2013 ACR criteria, the Symptomatic Impact Scoring (SIQR) is ≥21,
- Acceptance of treatment that will continue 3 days a week for 6 weeks,
- The possibility of any change in medical treatment due to FMS during the study is not foreseen.
Who cannot join
- Known central or peripheral nervous system disease, progressive neurological damage,
- Any serious cardiovascular pathology,
- Sense, loss of sense of position, unhealed fracture or a surgical wound,
- Presence of uncontrolled hypertension,
- Failure to understand or perform simple commands.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Faculty of Medicine, Department of Sports Medicine
Istanbul
About this study
Official title: Comparison of the Effects of Balance-proprioception and Aerobic Exercises on Functional Status, Pain and Strength Parameters in Patients With Fibromyalgia Syndrome (FMS).
In this study, it was aimed to examine the effects of aerobic exercise and balance-proprioception exercises on pain, functionality and strength parameters of fibromyalgia patients and to compare the two exercise types.
Read the detailed description
In the study planned to evaluate the effect of aerobic and balance-proprioception exercises on the symptoms of the disease and the superiority of the two exercise models in patients with fibromyalgia syndrom (FMS), 62 women who meet the inclusion criteria will be randomly divided into two groups. Aerobic exercise group (n = 26) and balance-proprioception exercise group (n = 26) will be applied for 3 weeks a week, 6 days a week under the supervision of a physiotherapist in the exercise laboratory of the Istanbul Medical Faculty Sports Medicine Department. Pain (VAS), functional status (FİQ) and knee extension muscle strength (Cybex isokinetic dynamometer) will be evaluated before and after the program. Cognitive status will be evaluated with standardized Mini Mental Test only before the program.
- Conditions
- Fibromyalgia Syndrome
- Being tested
- therapeutic exercises
- Keywords
- Fibromyalgia, aerobic exercise, balance, proprioception, pain, strength
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic exercisesOther
Treatment that will continue 3 days a week for 6 weeks in female patients with fibromyalgia.
| Study group | Role | What they receive |
|---|---|---|
| balance-proprioception exercises group | Active comparator | balance-proprioception exercises group Receives: Other: therapeutic exercises |
| aerobic exercises group | Active comparator | aerobic exercises group Receives: Other: therapeutic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire (FIQ)
In order to evaluate the functional status in patients with FMS, FIQ Burchardt et al. It is a specific scale developed by. FIQ consists of 10 items. Calculation is made so that the upper limit of each item is 10 points. The maximum score that can be reached is 100. A high total score indicates that the person is more affected by the disease.
Measured: 6 weeks
Pain (Visual Analogue Scale)
Visual Analaog Scale is used to measure the severity of pain in patients. The patient is told that there is no "0" pain on the 10 cm ruler drawn on paper, "10" is the most experienced pain, and the patient is asked to mark on the ruler according to the severity of the pain he/she feels. The distance of the marked point from zero is recorded as the Visual Analogue Scale score in cm.
Measured: 6 weeks
Muscle Strength Evaluation
The CSMI Humac Norm 2015 isokinetic dynamometer will be used to evaluate muscle strength.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start24 Aug 2020
- Primary completion30 Oct 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadi Yavuz, Istanbul University
- Investigators
- Gökhan Metin, Professor, Study director, İstanbul Univesity, İstanbul Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437524
- Sponsor's protocol ID
- 196481654
- Acronym
- FMS
- Status last verified
- Dec 2020
- First submitted
- 17 Jun 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Balance-proprioception and Aerobic Exercises on Functional Status, Pain and Strength Parameters in Patients With Fibromyalgia Syndrome (FMS).
- ClinicalTrials.gov ID
- NCT04437524
- Acronym / sponsor ID
- FMS / 196481654
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Fibromyalgia, aerobic exercise, balance, proprioception, pain, strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 18 Jun 2020 (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, it was aimed to examine the effects of aerobic exercise and balance-proprioception exercises on pain, functionality and strength parameters of fibromyalgia patients and to compare the two exercise types.
Detailed description
In the study planned to evaluate the effect of aerobic and balance-proprioception exercises on the symptoms of the disease and the superiority of the two exercise models in patients with fibromyalgia syndrom (FMS), 62 women who meet the inclusion criteria will be randomly divided into two groups. Aerobic exercise group (n = 26) and balance-proprioception exercise group (n = 26) will be applied for 3 weeks a week, 6 days a week under the supervision of a physiotherapist in the exercise laboratory of the Istanbul Medical Faculty Sports Medicine Department. Pain (VAS), functional status (FİQ) and knee extension muscle strength (Cybex isokinetic dynamometer) will be evaluated before and after the program. Cognitive status will be evaluated with standardized Mini Mental Test only before the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| balance-proprioception exercises group | Active comparator | Other: therapeutic exercisesbalance-proprioception exercises group |
| aerobic exercises group | Active comparator | Other: therapeutic exercisesaerobic exercises group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being between the ages of 18 and 60,
- Symptoms lasting longer than 3 months,
- According to the 2013 ACR criteria, the Pain Settlement Score (PLI) is ≥17,
- According to the 2013 ACR criteria, the Symptomatic Impact Scoring (SIQR) is ≥21,
- Acceptance of treatment that will continue 3 days a week for 6 weeks,
Key exclusion criteria (5 listed)
- Known central or peripheral nervous system disease, progressive neurological damage,
- Any serious cardiovascular pathology,
- Sense, loss of sense of position, unhealed fracture or a surgical wound,
- Presence of uncontrolled hypertension,
- Failure to understand or perform simple commands.
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 |
|---|---|---|
| therapeutic exercisesTreatment that will continue 3 days a week for 6 weeks in female patients with fibromyalgia. | Other | aerobic exercises group, balance-proprioception exercises group |
Primary outcome
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: 6 weeks
In order to evaluate the functional status in patients with FMS, FIQ Burchardt et al. It is a specific scale developed by. FIQ consists of 10 items. Calculation is made so that the upper limit of each item is 10 points. The maximum score that can be reached is 100. A high total score indicates that the person is more affected by the disease.
Pain (Visual Analogue Scale)
Time frame: 6 weeks
Visual Analaog Scale is used to measure the severity of pain in patients. The patient is told that there is no "0" pain on the 10 cm ruler drawn on paper, "10" is the most experienced pain, and the patient is asked to mark on the ruler according to the severity of the pain he/she feels. The distance of the marked point from zero is recorded as the Visual Analogue Scale score in cm.
Muscle Strength Evaluation
Time frame: 6 weeks
The CSMI Humac Norm 2015 isokinetic dynamometer will be used to evaluate muscle strength.
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 9 Dec 2020.
Related trials for Fibromyalgia Syndrome
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
Gökhan Metin, Professor study director
İstanbul Univesity, İstanbul Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic exercises in people with Fibromyalgia Syndrome, run by Istanbul 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 6 inclusion and 5 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 9 Dec 2020. 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 (FIQ) (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2020.