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Acute and Long-Term Effects of Integrated Myofascial Release Therapy on Respiratory Function in Healthy Adults (EMGT-RESP)

10. September 2026 aktualisiert von: Ece ACAR, Karabuk University

Acute and Long-Term Effects of Integrated Myofascial Release Therapy on Pulmonary Function, Thoracic Mobility, and Cough Strength in Healthy Adults

This study will investigate the immediate and longer-term effects of integrated myofascial release therapy on breathing-related outcomes in healthy adults.

Participants will receive integrated myofascial release therapy twice a week for 6 weeks, for a total of 12 treatment sessions. Assessments will be performed before treatment, immediately after the first treatment session, at the end of the 6-week treatment period, and 1 month and 3 months after treatment.

The study will evaluate pulmonary function, cough strength, and chest mobility. The aim is to determine both the immediate response to a single treatment session and whether repeated treatment produces effects that are maintained during follow-up.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Myofascial release therapy is a manual therapy approach intended to reduce restrictions in fascial tissues and improve tissue mobility. Fascial structures surrounding the thorax, neck, shoulder, and upper extremity may contribute to chest wall mechanics and movements associated with breathing.

Previous studies have mainly focused on immediate or short-term responses to myofascial release techniques, while evidence regarding cumulative and sustained effects remains limited. Therefore, this prospective single-group interventional study is designed to evaluate both the immediate response to the first treatment session and the effects of repeated treatment over time.

Integrated myofascial release therapy will be applied to fascial structures associated with the upper extremity, neck-shoulder region, and pectoral/anterior chest region. Treatment will be administered twice weekly for 6 weeks, for a total of 12 sessions.

Assessments will be conducted at five time points: before treatment (T0), immediately after the first treatment session (T1), at the end of the 6-week treatment period (T2), 1 month after treatment (T3), and 3 months after treatment (T4).

Pulmonary function will be evaluated using spirometry, including forced vital capacity, forced expiratory volume in 1 second, the FEV1/FVC ratio, and peak expiratory flow. Cough strength will be assessed using peak cough flow. Thoracic mobility will be evaluated using chest expansion measurements at the axillary, xiphoid/epigastric, and subcostal levels.

The study is intended to distinguish the acute response to a single session from the cumulative effect of repeated treatment and the persistence of any observed effects after treatment has ended.

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Türkei (türkiye)
    • Karabük Province
      • Karabük, Karabük Province, Türkei (türkiye), 78050
        • Karabuk University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Inclusion Criteria:

  • Age 18 years or older.
  • Ability to communicate in Turkish.
  • Voluntary agreement to participate in the study.
  • Ability to attend the scheduled assessment and treatment sessions regularly.

Exclusion Criteria:

  • Asthma, clinically significant dyspnea, or chronic pulmonary disease.
  • Influenza, COVID-19, or another acute respiratory tract infection within the previous 6 weeks that may affect respiratory function.
  • Recent surgery involving the neck, shoulder, or thoracic region.
  • History of rib fracture or an acute musculoskeletal condition that would make manual therapy inappropriate.
  • Serious cardiovascular, neurological, or systemic disease that could prevent safe participation in the assessments.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Integrated Myofascial Release Therapy
Participants in this arm will receive integrated myofascial release therapy twice weekly for 6 weeks, for a total of 12 sessions. Each session will last approximately 20-30 minutes. The intervention will include single arm pull, lateral neck-shoulder myofascial release, and pectoral-anterior chest cross-hand release techniques applied in a standardized sequence.
Sonstiges: Other
Integrated myofascial release therapy will be administered twice weekly for 6 weeks, for a total of 12 sessions. Each session will last approximately 20-30 minutes. The intervention will include single arm pull, lateral neck-shoulder myofascial release, and pectoral-anterior chest cross-hand release techniques. Techniques will be applied using slow, low-intensity, pain-free manual contact while following tissue resistance and release. The sequence and target regions will be standardized across sessions.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Xiphoid-Level Chest Expansion
Zeitfenster: Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Chest expansion will be measured at the xiphoid/epigastric level using a non-elastic measuring tape. The difference between chest circumference at maximal inspiration and maximal expiration will be calculated in centimeters. Measurements will be repeated using the same anatomical landmarks and standardized participant position across assessment time points.
Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Forced Vital Capacity (FVC)
Zeitfenster: Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Forced vital capacity will be assessed using spirometry and recorded in liters. Participants will perform repeated acceptable forced expiratory maneuvers according to the standardized measurement procedure, and the highest acceptable FVC value will be used for analysis.
Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Change in Forced Expiratory Volume in 1 Second (FEV1)
Zeitfenster: Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Forced expiratory volume in 1 second will be assessed using spirometry and recorded in liters. Participants will perform repeated acceptable forced expiratory maneuvers, and the highest acceptable FEV1 value will be used for analysis.
Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Change in FEV1/FVC Ratio
Zeitfenster: Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
The FEV1/FVC ratio will be calculated automatically by the spirometry device from acceptable forced expiratory maneuvers and recorded as a percentage.
Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Change in Peak Expiratory Flow (PEF)
Zeitfenster: Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Peak expiratory flow will be assessed during standardized spirometry maneuvers. The highest technically acceptable PEF value will be recorded and used for analysis, expressed according to the spirometry device output.
Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Change in Peak Cough Flow (PCF)
Zeitfenster: Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Peak cough flow will be assessed using a portable peak flow meter and recorded in liters per minute. Participants will perform at least three technically appropriate voluntary cough maneuvers after a deep inspiration, and the highest technically acceptable PCF value will be used for analysis.
Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Change in Axillary-Level Chest Expansion
Zeitfenster: Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Chest expansion at the axillary level will be measured using a non-elastic measuring tape positioned approximately at the level of the third rib. The difference between chest circumference at maximal inspiration and maximal expiration will be calculated in centimeters. The same participant position and anatomical landmarks will be used across all assessment time points
Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Change in Subcostal-Level Chest Expansion
Zeitfenster: Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).
Chest expansion at the subcostal level will be measured using a non-elastic measuring tape. The difference between chest circumference at maximal inspiration and maximal expiration will be calculated in centimeters. The same standardized participant position and anatomical landmarks will be used at each assessment time point.
Baseline (T0), immediately after the first treatment session (T1), at the end of 6 weeks of treatment (T2), 1 month after treatment (T3), and 3 months after treatment (T4).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Karabuk University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

16. Oktober 2026

Primärer Abschluss (Geschätzt)

12. Februar 2027

Studienabschluss (Geschätzt)

29. Juni 2027

Studienanmeldedaten

Zuerst eingereicht

10. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. September 2026

Zuerst gepostet (Tatsächlich)

16. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • KBU-EMGT-RESP-2026-01

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified individual participant data underlying the results reported in publications from this study may be shared with qualified researchers upon reasonable request. Shared data will not include information that could directly identify individual participants.

IPD-Sharing-Zeitrahmen

Data will be available beginning 6 months after publication of the main study results and for 5 years thereafter.

IPD-Sharing-Zugriffskriterien

Data may be made available to qualified researchers who submit a methodologically sound proposal with a clearly defined scientific purpose. Requests will be reviewed by the study investigators. Approved requestors may be required to sign a data use agreement before access is granted.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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