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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).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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.

Turkey (Türkiye)1 site
  • RA Fizyoterapi

    Istanbul, Tuzla, 34940

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07017101
Study groupRoleWhat they receive
PILATES BASED EXERCISE TRAINING WITH REFORMERExperimentalPilates training with reformer for 6 weeks
Receives: Other: PILATES BASED EXERCISE TRAINING WITH REFORMER
NEUROPHYSIOLOGICAL FASCILITATION TECHNIQUESActive comparatorControl 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.

  1. 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.

  1. First posted12 Jun 2025
  2. Study start23 Feb 2025
  3. Primary completion21 Jun 2025 (estimated)
  4. Study completion25 Jun 2025 (estimated)

Resources

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)
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

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.

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