NCT07017101

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2025

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

May 19, 2025

Last Update Submit

June 3, 2025

Conditions

Outcome Measures

Primary Outcomes (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

    6 weeks after registration

Study Arms (2)

PILATES BASED EXERCISE TRAINING WITH REFORMER

EXPERIMENTAL

Pilates training with reformer for 6 weeks

Other: PILATES BASED EXERCISE TRAINING WITH REFORMER

NEUROPHYSIOLOGICAL FASCILITATION TECHNIQUES

ACTIVE COMPARATOR

Control group

Other: PILATES BASED EXERCISE TRAINING WITH REFORMEROther: NEUROPHYSIOLOGICAL FASCILITATION TECHNIQUES

Interventions

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.

Also known as: 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
NEUROPHYSIOLOGICAL FASCILITATION TECHNIQUESPILATES BASED EXERCISE TRAINING WITH REFORMER

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.

Also known as: 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
NEUROPHYSIOLOGICAL FASCILITATION TECHNIQUES

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RA Fizyoterapi

Istanbul, Tuzla, 34940, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Gamze Aydın

    Okan Üniversitesi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI 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

Study Record Dates

First Submitted

May 19, 2025

First Posted

June 12, 2025

Study Start

February 23, 2025

Primary Completion

June 21, 2025

Study Completion

June 25, 2025

Last Updated

June 12, 2025

Record last verified: 2025-06

Locations