- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04845802
Effects of Inspiratory Muscle Training on Diaphragm Thickness, Respiratory Muscle Strength and Balance in Dancers.
13. april 2021 opdateret af: Hakan Aksu, Istanbul University
Dance is a performing art form consisting of sports and art intertwined and complex dynamic choreographic figures were handled aesthetically and physically of narrative.
Scientific studies are insufficient on dance and health and performance of dancers in the literature although dance is the most used type of art and sport in all societies and for all age groups.
It is seen that the core stabilization (central forces) of the dancers is insufficient when the current studies were examined, this insufficient stabilization causes biomechanical changes in the trunk, and indirectly affects the lower extremities.
Consequently, insufficient stabilization was shown to be caused impairment of force generation and injuries.
In addition, lack of core stabilization of dancers may cause impairment in balance and postural control.
Therefore, dancers need a good postural control with provided by an effective core stabilization training in order to exhibit a successful and healthy performance.
It is shown that inspiratory muscle training (IMT) improves diaphragm strength and diaphragm thickness.
Considering the relation between diaphragm muscle forming the upper (ceiling) part of the core area, and balance, IMT may also have an impact on postural control and balance alongside the standard clinical parameters such as respiratory muscle strength and diaphragm thickness in dancers.
Thus, the aim of this study was to investigate the effects of inspiratory muscle training on diaphragm thickness, postural stability, balance, respiratory muscle strength in dancers.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Hakan Aksu
- Telefonnummer: +90 5332165106
- E-mail: fizyoterapistha@gmail.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Dancer (for least two years)
- Stable clinical condition (no injury in last 2 months)
Exclusion Criteria:
- Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility
- Having of chronic pulmonary disease
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Training Group
Dancers in this group will perform inspiratory muscle training for 30 breaths, twice daily [morning: between 7:00 and 13:00 and evening: between 16:00 and 22:00], 7 days per week for 8 weeks, with a breathing frequency of 15 breaths per minute and a duty cycle of 0.5.
One exercise session will be supervised in a clinic per week, other sessions will be performed at home in every week during the training.
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A mechanical pressure threshold loading device (POWERbreathe, POWERbreathe International Ltd, UK) will be used for the training.
Training intensity will set at 60% of the maximum inspiratory pressure.
Andre navne:
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Sham-komparator: Sham Group
Dancers in this group will perform inspiratory muscle training for 30 breaths, twice daily [morning: between 7:00 and 13:00 and evening: between 16:00 and 22:00], 7 days per week for 8 weeks, with a breathing frequency of 15 breaths per minute and a duty cycle of 0.5.
One exercise session will be supervised in a clinic per week, other sessions will be performed at home in every week during the training.
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Dancers will be perform at a load setting of level 1 (corresponding to ~10% baseline MIP), using the same device as the training group.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change of baseline postural stability test score in Biodex Balance System after 8 weeks
Tidsramme: Eight weeks
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The Postural Stability Test evaluates static balance of participants.
Postural Stability Test emphasizes a patient's ability to maintain center of balance.
The patient's score on this test assesses deviations from center, thus a lower score is more desirable than a higher score.
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Eight weeks
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Change of baseline athlete single leg stability score in Biodex Balance System after 8 weeks
Tidsramme: Eight weeks
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The test protocol for the Athlete Single Leg Stability Testing allows clinicians to test athletes against data derived from studies using the Biodex Balance System.
The stability level will challenge athletes and provide the data necessary to assess the athlete's single leg postural stability.
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Eight weeks
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Change of baseline limits of stability test score in Biodex Balance System after 8 weeks
Tidsramme: Eight weeks
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Limits of stability test evaluates dynamic balance of participants.
Biodex balance system measures limits of stability for forward, backward, right and left side movements.
It will calculate the maximum distance a person can lean without losing balance.
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Eight weeks
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Change of baseline diaphragm thickness after 8 weeks
Tidsramme: Eight weeks
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Two-dimensional B-mode ultrasound will be measure diaphragm thickness at the zone of apposition during inspiration or expiration using the intercostal approach.
Diaphragm thickness will be measure as the vertical distance between the pleural and peritoneal layer at both Total Lung Capacity [TLC] and Functional Residual Capacity [FRC].
Measurements will be perform on the right hemidiaphragm with the volunteer in the supine position.
All measurements will be perform 3 times and the average value for each calculate.
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Eight weeks
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Change of baseline maximum inspiratory pressure after 8 weeks
Tidsramme: Eight weeks
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Maximum inspiratory pressure (MIP) will be measure using a hand-held mouth pressure device.
Three maximal manoeuvres will perform and the highest value record.
Indirect measure of respiratory (inspiratory) muscle strength, expressed in cmH20.
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Eight weeks
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Change of baseline maximum expiratory pressure after 8 weeks
Tidsramme: Eight weeks
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Maximum expiratory pressure (MEP) will be measure using a hand-held mouth pressure device.
Three maximal manoeuvres will perform and the highest value record.
Indirect measure of respiratory (expiratory) muscle strength, expressed in cmH20.
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Eight weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change of baseline biering-sorenson test score after 8 weeks
Tidsramme: Eight weeks
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Eight weeks
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Change of baseline oswestry disability index after 8 weeks
Tidsramme: Eight weeks
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Eight weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Sensu Dincer, Dr., Istanbul University Faculty of Medicine Sports Medicine Department
- Ledende efterforsker: Turker Sahinkaya, Lecturer, Istanbul University Faculty of Medicine Sports Medicine Department
- Studieleder: Bulent Bayraktar, Prof. Dr., Istanbul University Faculty of Medicine Sports Medicine Department
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Ferraro FV, Gavin JP, Wainwright T, McConnell A. The effects of 8 weeks of inspiratory muscle training on the balance of healthy older adults: a randomized, double-blind, placebo-controlled study. Physiol Rep. 2019 May;7(9):e14076. doi: 10.14814/phy2.14076.
- Janssens L, McConnell AK, Pijnenburg M, Claeys K, Goossens N, Lysens R, Troosters T, Brumagne S. Inspiratory muscle training affects proprioceptive use and low back pain. Med Sci Sports Exerc. 2015 Jan;47(1):12-9. doi: 10.1249/MSS.0000000000000385.
- Watson T, Graning J, McPherson S, Carter E, Edwards J, Melcher I, Burgess T. DANCE, BALANCE AND CORE MUSCLE PERFORMANCE MEASURES ARE IMPROVED FOLLOWING A 9-WEEK CORE STABILIZATION TRAINING PROGRAM AMONG COMPETITIVE COLLEGIATE Dancers. Int J Sports Phys Ther. 2017 Feb;12(1):25-41.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. maj 2021
Primær færdiggørelse (Forventet)
1. september 2021
Studieafslutning (Forventet)
1. oktober 2021
Datoer for studieregistrering
Først indsendt
12. april 2021
Først indsendt, der opfyldte QC-kriterier
13. april 2021
Først opslået (Faktiske)
15. april 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. april 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. april 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Iuhaksu01
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
Patients may not want to share the data with anyone other than the researchers involved in the study.
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Kliniske forsøg med Inspiratory muscle training(high-IMT group)
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