Acute and Long-Term Effects of Integrated Myofascial Release Therapy on Respiratory Function in Healthy Adults (EMGT-RESP)
10 september 2026 bijgewerkt door: 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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
40
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Ece Acar, Assist Prof
- Telefoonnummer: 05457925035
- E-mail: acarkosanece@gmail.com
Studie Locaties
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Karabük Province
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Karabük, Karabük Province, Turkije (Türkiye), 78050
- Karabuk University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
|
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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Xiphoid-Level Chest Expansion
Tijdsspanne: 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.
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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).
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Forced Vital Capacity (FVC)
Tijdsspanne: 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.
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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).
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Change in Forced Expiratory Volume in 1 Second (FEV1)
Tijdsspanne: 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.
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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).
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Change in FEV1/FVC Ratio
Tijdsspanne: 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.
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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).
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Change in Peak Expiratory Flow (PEF)
Tijdsspanne: 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).
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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.
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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).
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Change in Peak Cough Flow (PCF)
Tijdsspanne: 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).
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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.
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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).
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Change in Axillary-Level Chest Expansion
Tijdsspanne: 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).
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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
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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).
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Change in Subcostal-Level Chest Expansion
Tijdsspanne: 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).
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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).
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.
- Bohunicky S, Rutherford L, Harrison KL, Malone Q, Glazebrook CM, Scribbans TD. Immediate effects of myofascial release to the pectoral fascia on posture, range of motion, and muscle excitation: a crossover randomized clinical trial. J Man Manip Ther. 2024 Oct;32(5):495-505. doi: 10.1080/10669817.2024.2316414. Epub 2024 Feb 16.
- Marizeiro DF, Florencio ACL, Nunes ACL, Campos NG, Lima POP. Immediate effects of diaphragmatic myofascial release on the physical and functional outcomes in sedentary women: A randomized placebo-controlled trial. J Bodyw Mov Ther. 2018 Oct;22(4):924-929. doi: 10.1016/j.jbmt.2017.10.008. Epub 2017 Oct 25.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
16 oktober 2026
Primaire voltooiing (Geschat)
12 februari 2027
Studie voltooiing (Geschat)
29 juni 2027
Studieregistratiedata
Eerst ingediend
10 september 2026
Eerst ingediend dat voldeed aan de QC-criteria
10 september 2026
Eerst geplaatst (Werkelijk)
16 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
16 september 2026
Laatste update ingediend die voldeed aan QC-criteria
10 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- KBU-EMGT-RESP-2026-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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-tijdsbestek voor delen
Data will be available beginning 6 months after publication of the main study results and for 5 years thereafter.
IPD-toegangscriteria voor delen
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.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .