Acute and Long-Term Effects of Integrated Myofascial Release Therapy on Respiratory Function in Healthy Adults (EMGT-RESP)
10. september 2026 oppdatert av: 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.
Studieoversikt
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ece Acar, Assist Prof
- Telefonnummer: 05457925035
- E-post: acarkosanece@gmail.com
Studiesteder
-
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Karabük Province
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Karabük, Karabük Province, Tyrkia (Türkiye), 78050
- Karabuk University
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Xiphoid-Level Chest Expansion
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Forced Vital Capacity (FVC)
Tidsramme: 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).
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Change in Forced Expiratory Volume in 1 Second (FEV1)
Tidsramme: 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).
|
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Change in FEV1/FVC Ratio
Tidsramme: 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)
Tidsramme: 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.
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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)
Tidsramme: 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.
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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
Tidsramme: 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).
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Change in Subcostal-Level Chest Expansion
Tidsramme: 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).
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
16. oktober 2026
Primær fullføring (Antatt)
12. februar 2027
Studiet fullført (Antatt)
29. juni 2027
Datoer for studieregistrering
Først innsendt
10. september 2026
Først innsendt som oppfylte QC-kriteriene
10. september 2026
Først lagt ut (Faktiske)
16. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KBU-EMGT-RESP-2026-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
Data will be available beginning 6 months after publication of the main study results and for 5 years thereafter.
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .