Fibromyalgia (FM)NCT07017101
Effect of Neurophysiological Facilitation Techniques Applied in Addition to Pilates-based Exercise Training in Individuals With Fibromyalgia on Respiratory Parameters, Fatigue and Quality of Life
A study testing PILATES BASED EXERCISE TRAINING WITH REFORMER and NEUROPHYSIOLOGICAL FASCILITATION TECHNIQUES in people with Fibromyalgia (FM), run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study was to examine the effect of neurophysiological facilitation techniques applied in addition to pilates-based exercise training in individuals with fibromyalgia on body composition, core stabilization, respiratory parameters, fatigue and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia (FM)
- What is being tested?
- PILATES BASED EXERCISE TRAINING WITH REFORMER and NEUROPHYSIOLOGICAL FASCILITATION TECHNIQUES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2025to 25 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65,
- Having been diagnosed with FM by a specialist physician according to ACR 2016 criteria
- Volunteering to participate in the study,
Who cannot join
- Not showing voluntary participation in the study,
- Orthopedic, neurological and cardiopulmonary diseases that will prevent him from exercising
- Existence,
- Pregnancy,
- Having exercised regularly for the last 3 months,
- Individuals with a known history of psychiatric illness and receiving active psychiatric treatment
- Will be excluded from research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The aim of our study was to examine the effect of neurophysiological facilitation techniques applied in addition to pilates-based exercise training in individuals with fibromyalgia on body composition, core stabilization, respiratory parameters, fatigue and quality of life.
Read the detailed description
Fibromyalgia (FM) is a chronic musculoskeletal problem characterized by widespread pain in the body accompanied by other symptoms such as fatigue, sleep disturbance, morning stiffness and increased sensitivity in some anatomical areas. Chronic pain in FM causes physical and emotional stress and can reduce quality of life. In FM management, it is recommended to combine pharmacological and non-pharmacological methods with the active participation of the person. Exercise is an important part of non-pharmacological approaches. The purpose of exercise in FM management is to reduce pain and fatigue, increase muscle strength, flexibility and endurance, and contribute to the person's functionality, quality of life. Exercise also provides relaxation and causes healing effects in the emotional state. Recent studies have shown that the use of clinical pilates exercises has become popular in individuals with fibromyalgia.
Pilates was developed by Joseph Humbertus Pilates in the early 1900s and was adapted by health professionals for therapeutic use and called "Clinical Pilates". It is a popular exercise method used in both healthy and patient populations today. Clinical Pilates exercises train the mind to consciously focus on controlling the movement and posture of the body. It aims to improve the relationship between mind and body with the active participation of the patient. It is also different from other types of exercise because it contains a breathing component. Pilates exercises can be applied in two methods: mat pilates and equipment pilates. Mat pilates exercises are done on a mat, while equipment pilates exercises are done using special types of equipment such as reformer, cadillac, wunda chair, ladder barrel.
Reformer is the most popular equipment among pilates equipment. It consists of springs, rollers, ropes and a sliding platform that provide variable resistance. Joseph Pilates believed that starting exercise in a moving/sliding horizontal plane and advancing other exercises with additional gravitational forces added was important to reduce stress on the joints. Therefore, he designed the reformer that allowed the exercises to be applied to the horizontal plane. Exercises with the reformer are done against resistance in the horizontal plane, where gravity is eliminated. Reformer exercises focus on maintaining the neutral position and quality of body alignment, and also exercises can be done in different positions, such as kneeling, lying on the side, standing. Some studies show that pilates exercises applied with reformer, pain and balance in working women with chronic low back pain (Basakcı Calık et al., 2018), pain, function and kinesophobia in individuals with chronic low back pain (Altan et al. 2009 - Patti et al., 2015) has shown positive effects on balance, functionality, cor stabilization, fatigue severity and quality of life in patients with multiple sclerosis (Frank et al., 2017).Although mat pilates has been shown to be an effective and safe treatment method to reduce symptoms in individuals with fibromyalgia, studies for the effects of reformer pilates in FM are limited (Korkmaz, 2010- Palekar, 2014). The literature has shown that mat pilates exercises for individuals with FM are usually performed as a supervised schedule (Franco et al., 2019). Neurophysiological facilitation techniques are a non-invasive exercise technique and are based on the combination of maximal resistance applied during the joint range of motion with posture and stretching reflexes and primitive movement patterns (Çetintaş and Kamanlı, 2012). Hand contacts, communication with the patient, stretching, traction, aproximation, maximal resistance applications, strengthening methods, facilitation techniques applied to ensure harmonious and indequent contractions of the muscles (Çetintaş and Kamanlı, 2012). These exercises do not include any electrotherapy methods. It is an exercise approach aimed at improving movement and function using the natural working principles of the nervous system and muscles. In this method, movement patterns are used that allow the muscles to work together and coordinate the movement of the nervous system (Çetintaş and Kamanlı, 2012). Proprioceptive Neuromuscular Fascitation (PNF) is defined as facilitating the responses of the neuromuscular mechanism by stimulation of proprioceptors. The basic principle of PNF is based on the fact that the movements in the human body have a rotational and oblic character and a greater response can be obtained with the movement against maximum resistance. PNF exercises are useful for pain in individuals with fibromyalgia. At the same time, the sensory-motor system is effective in regulation and balance development. Rhythmic stabilization technique and Pilates motor control exercises have been shown to lead to significant improvement in pain and joint range of motion (Malla, 2018). In a study comparing PNF exercises and the McKenzie method in individuals with fibromyalgia, the combined isotonic contraction technique with the PNF rhythmic stabilization technique was shown to be effective in improving the quality of life of individuals (Anggiat et al., 2018). In another study in individuals with fibromyalgia, the PNF combined isotonic contraction technique was shown to provide the benefit of improving functional capacity and reducing pain (Zaworski and Latosiewicz, 2018). It is stated that PNF exercises contribute to reducing pain, increasing muscle strength and functional capacity and quality of life (Arslan and Erbahçeci, 2016). In studies using pilates exercises and PNF exercises in the literature, both methods have been shown to have an effect on some parameters such as fibromyalgia pain, functional level and quality of life. Studies in the literature show that both methods are among the treatment methods frequently used in the clinic by physiotherapists, but it is difficult to provide adequate information about which method is more effective. In the light of this information, the aim of our study is to examine the effect of neurophysiological facilitation techniques applied in addition to pilates-based exercise training in individuals with fibromyalgia on body composition, cor stabilization, respiratory parameters, fatigue and quality of life.
- Conditions
- Fibromyalgia (FM)
- Being tested
- PILATES BASED EXERCISE TRAINING WITH REFORMER, NEUROPHYSIOLOGICAL FASCILITATION TECHNIQUES
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PILATES BASED EXERCISE TRAINING WITH REFORMEROther
Also called Effect of neurophysiological facilitation techniques applied in addition to pilates-based exercise training in individuals with fibromyalgia on respiratory parameters, fatigue and quality of life
Participants will only be given training on pilates-based exercises with reformers. Breathing, which are the 5 key elements of clinical pilates exercises after the first evaluation to individuals,
Focus, rib cage placement, shoulder placement, head and neck placement will be taught. Whole
Participants will be informed about the reformer instrument and work schedule. Exercises 2 days a week, 6
Will be applied throughout the week.
NEUROPHYSIOLOGICAL FASCILITATION TECHNIQUESOther
Also called Effect of neurophysiological facilitation techniques applied in addition to pilates-based exercise training in individuals with fibromyalgia on respiratory parameters, fatigue and quality of life
In addition to reformer-based pilates training, participants will be given Neurophysiological facilitation techniques training. Neurophysiological facilitation techniques are non-invasive, easy to apply, the physiotherapist is active
It consists of exercises made with guidance and active participation of the patient. These techniques are any
Does not contain an electrotherapy current. In this study, the neurophysiological
Facilitation techniques, perioral stimulation, intercostal tension, anterior basal lift, vertebral pressure, medium
Graded manual pressure and abdominal co-contraction techniques and each technique for 15 seconds
Will be applied. Neurophysiological facilitation techniques are used to repeat 10 sessions each session throughout the treatment.
It will be done.
| Study group | Role | What they receive |
|---|---|---|
| PILATES BASED EXERCISE TRAINING WITH REFORMER | Experimental | Pilates training with reformer for 6 weeks Receives: Other: PILATES BASED EXERCISE TRAINING WITH REFORMER |
| NEUROPHYSIOLOGICAL FASCILITATION TECHNIQUES | Active comparator | Control group Receives: Other: PILATES BASED EXERCISE TRAINING WITH REFORMER; Other: NEUROPHYSIOLOGICAL FASCILITATION TECHNIQUES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of neurophysiological facilitation techniques applied in addition to pilates-based exercise training on respiratory parameters, fatigue and quality of life in individuals with fibromyalgia
Measured: 6 weeks after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start23 Feb 2025
- Primary completion21 Jun 2025 (estimated)
- Study completion25 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia (FM)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliye Rabia AKKAYA, Okan University
- Investigators
- Gamze Aydın, Study director, Okan Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017101
- Sponsor's protocol ID
- OKANU-FTR-ARA-01
- Status last verified
- Jun 2025
- First submitted
- 19 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neurophysiological Facilitation Techniques Applied in Addition to Pilates-based Exercise Training in Individuals With Fibromyalgia on Respiratory Parameters, Fatigue and Quality of Life
- ClinicalTrials.gov ID
- NCT07017101
- Acronym / sponsor ID
- OKANU-FTR-ARA-01
- Conditions
- Fibromyalgia (FM)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 23 Feb 2025 (actual)
- Primary completion
- 21 Jun 2025 (estimated)
- Study completion
- 25 Jun 2025 (estimated)
- First posted
- 12 Jun 2025 (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.
The aim of our study was to examine the effect of neurophysiological facilitation techniques applied in addition to pilates-based exercise training in individuals with fibromyalgia on body composition, core stabilization, respiratory parameters, fatigue and quality of life.
Detailed description
Fibromyalgia (FM) is a chronic musculoskeletal problem characterized by widespread pain in the body accompanied by other symptoms such as fatigue, sleep disturbance, morning stiffness and increased sensitivity in some anatomical areas. Chronic pain in FM causes physical and emotional stress and can reduce quality of life. In FM management, it is recommended to combine pharmacological and non-pharmacological methods with the active participation of the person. Exercise is an important part of non-pharmacological approaches. The purpose of exercise in FM management is to reduce pain and fatigue, increase muscle strength, flexibility and endurance, and contribute to the person's functionality, quality of life. Exercise also provides relaxation and causes healing effects in the emotional state. Recent studies have shown that the use of clinical pilates exercises has become popular in individuals with fibromyalgia.
Pilates was developed by Joseph Humbertus Pilates in the early 1900s and was adapted by health professionals for therapeutic use and called "Clinical Pilates". It is a popular exercise method used in both healthy and patient populations today. Clinical Pilates exercises train the mind to consciously focus on controlling the movement and posture of the body. It aims to improve the relationship between mind and body with the active participation of the patient. It is also different from other types of exercise because it contains a breathing component. Pilates exercises can be applied in two methods: mat pilates and equipment pilates. Mat pilates exercises are done on a mat, while equipment pilates exercises are done using special types of equipment such as reformer, cadillac, wunda chair, ladder barrel.
Reformer is the most popular equipment among pilates equipment. It consists of springs, rollers, ropes and a sliding platform that provide variable resistance. Joseph Pilates believed that starting exercise in a moving/sliding horizontal plane and advancing other exercises with additional gravitational forces added was important to reduce stress on the joints. Therefore, he designed the reformer that allowed the exercises to be applied to the horizontal plane. Exercises with the reformer are done against resistance in the horizontal plane, where gravity is eliminated. Reformer exercises focus on maintaining the neutral position and quality of body alignment, and also exercises can be done in different positions, such as kneeling, lying on the side, standing. Some studies show that pilates exercises applied with reformer, pain and balance in working women with chronic low back pain (Basakcı Calık et al., 2018), pain, function and kinesophobia in individuals with chronic low back pain (Altan et al. 2009 - Patti et al., 2015) has shown positive effects on balance, functionality, cor stabilization, fatigue severity and quality of life in patients with multiple sclerosis (Frank et al., 2017).Although mat pilates has been shown to be an effective and safe treatment method to reduce symptoms in individuals with fibromyalgia, studies for the effects of reformer pilates in FM are limited (Korkmaz, 2010- Palekar, 2014). The literature has shown that mat pilates exercises for individuals with FM are usually performed as a supervised schedule (Franco et al., 2019). Neurophysiological facilitation techniques are a non-invasive exercise technique and are based on the combination of maximal resistance applied during the joint range of motion with posture and stretching reflexes and primitive movement patterns (Çetintaş and Kamanlı, 2012). Hand contacts, communication with the patient, stretching, traction, aproximation, maximal resistance applications, strengthening methods, facilitation techniques applied to ensure harmonious and indequent contractions of the muscles (Çetintaş and Kamanlı, 2012). These exercises do not include any electrotherapy methods. It is an exercise approach aimed at improving movement and function using the natural working principles of the nervous system and muscles. In this method, movement patterns are used that allow the muscles to work together and coordinate the movement of the nervous system (Çetintaş and Kamanlı, 2012). Proprioceptive Neuromuscular Fascitation (PNF) is defined as facilitating the responses of the neuromuscular mechanism by stimulation of proprioceptors. The basic principle of PNF is based on the fact that the movements in the human body have a rotational and oblic character and a greater response can be obtained with the movement against maximum resistance. PNF exercises are useful for pain in individuals with fibromyalgia. At the same time, the sensory-motor system is effective in regulation and balance development. Rhythmic stabilization technique and Pilates motor control exercises have been shown to lead to significant improvement in pain and joint range of motion (Malla, 2018). In a study comparing PNF exercises and the McKenzie method in individuals with fibromyalgia, the combined isotonic contraction technique with the PNF rhythmic stabilization technique was shown to be effective in improving the quality of life of individuals (Anggiat et al., 2018). In another study in individuals with fibromyalgia, the PNF combined isotonic contraction technique was shown to provide the benefit of improving functional capacity and reducing pain (Zaworski and Latosiewicz, 2018). It is stated that PNF exercises contribute to reducing pain, increasing muscle strength and functional capacity and quality of life (Arslan and Erbahçeci, 2016). In studies using pilates exercises and PNF exercises in the literature, both methods have been shown to have an effect on some parameters such as fibromyalgia pain, functional level and quality of life. Studies in the literature show that both methods are among the treatment methods frequently used in the clinic by physiotherapists, but it is difficult to provide adequate information about which method is more effective. In the light of this information, the aim of our study is to examine the effect of neurophysiological facilitation techniques applied in addition to pilates-based exercise training in individuals with fibromyalgia on body composition, cor stabilization, respiratory parameters, fatigue and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PILATES BASED EXERCISE TRAINING WITH REFORMER | Experimental | Other: PILATES BASED EXERCISE TRAINING WITH REFORMERPilates training with reformer for 6 weeks |
| NEUROPHYSIOLOGICAL FASCILITATION TECHNIQUES | Active comparator | Other: PILATES BASED EXERCISE TRAINING WITH REFORMER, Other: NEUROPHYSIOLOGICAL FASCILITATION TECHNIQUESControl group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being between the ages of 18-65,
- Having been diagnosed with FM by a specialist physician according to ACR 2016 criteria
- Volunteering to participate in the study,
Key exclusion criteria (7 listed)
- Not showing voluntary participation in the study,
- Orthopedic, neurological and cardiopulmonary diseases that will prevent him from exercising
- Existence,
- Pregnancy,
- Having exercised regularly for the last 3 months,
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 |
|---|---|---|
| PILATES BASED EXERCISE TRAINING WITH REFORMERAlso: Effect of neurophysiological facilitation techniques applied in addition to pilates-based exercise training in individuals with fibromyalgia on respiratory parameters, fatigue and quality of lifeParticipants will only be given training on pilates-based exercises with reformers. Breathing, which are the 5 key elements of clinical pilates exercises after the first evaluation to individuals, Focus, rib cage placement, shoulder placement, head and neck placement will be taught. Whole Participants will be informed about the reformer instrument and work schedule. Exercises 2 days a week, 6 Will be applied throughout the week. | Other | NEUROPHYSIOLOGICAL FASCILITATION TECHNIQUES, PILATES BASED EXERCISE TRAINING WITH REFORMER |
| NEUROPHYSIOLOGICAL FASCILITATION TECHNIQUESAlso: Effect of neurophysiological facilitation techniques applied in addition to pilates-based exercise training in individuals with fibromyalgia on respiratory parameters, fatigue and quality of lifeIn addition to reformer-based pilates training, participants will be given Neurophysiological facilitation techniques training. Neurophysiological facilitation techniques are non-invasive, easy to apply, the physiotherapist is active It consists of exercises made with guidance and active participation of the patient. These techniques are any Does not contain an electrotherapy current. In this study, the neurophysiological Facilitation techniques, perioral stimulation, intercostal tension, anterior basal lift, vertebral pressure, medium Graded manual pressure and abdominal co-contraction techniques and each technique for 15 seconds Will be applied. Neurophysiological facilitation techniques are used to repeat 10 sessions each session throughout the treatment. It will be done. | Other | NEUROPHYSIOLOGICAL FASCILITATION TECHNIQUES |
Primary outcome
Effect of neurophysiological facilitation techniques applied in addition to pilates-based exercise training on respiratory parameters, fatigue and quality of life in individuals with fibromyalgia
Time frame: 6 weeks after registration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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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.
Gamze Aydın study director
Okan Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PILATES BASED EXERCISE TRAINING WITH REFORMER and NEUROPHYSIOLOGICAL FASCILITATION TECHNIQUES in people with Fibromyalgia (FM), run by Okan 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 7 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: enrolling by invitation, as of the sponsor's last update on 12 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Effect of neurophysiological facilitation techniques applied in addition to pilates-based exercise training on respiratory parameters, fatigue and quality of life in individuals with fibromyalgia (time frame: 6 weeks after registration). 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 12 Jun 2025.