- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04803617
Investigation of Pectoralis Muscle Strength in Elderly With Interstitial Lung Disease
16. marts 2021 opdateret af: Habibedurdu
The Effect of Pectoralis Muscle Strength on Pulmonary Function in Elderly With Interstitial Lung Disease
Interstitial lung disease (ILD) is a restrictive lung disease characterized by impaired lung function, exercise limitation and skeletal muscle dysfunction.
There is limited data on skeletal muscle function in ILD, most of which are focused on the lower limb muscles.
The aim of this study were to evaluated the change of pectoralis muscle strength and relationship of pulmonary function with pectoralis muscle strength.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
This study consisted of intervention and control groups.
Thirty one patients with ILD were included in the patient's group and 37 healthy volunteers in the control group.
All participants were selected from the geriatric population.
Demographic and cardiopulmonary physiotherapy assessment of all participants were performed.
Lung function test, maximal inspiratory and expiratory pressure and pectoralis muscle strength were measured in participants of both groups.
All measurements were performed once.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
68
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Giresun, Kalkun
- Giresun University
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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
65 år til 85 år (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The patient's group was selected from among the patients who applied to Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital.
The control group was selected among volunteers invited from the local community.
Beskrivelse
Inclusion Criteria:
- Diagnosed with ILD by a multidisciplinary team according to the 2011 ATS/ERS guidelines for ILD
- Aged 65-85
Exclusion Criteria:
- Uncontrolled/active cardiovascular, metabolic, systemic or cancerous disease
- Significant orthopedic, neurologic or musculoskeletal comorbidity that limited functional independence
- No being able to cooperate
- Refuse to participate in the current study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Patient's group
geriatric patients with interstitial lung disease
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In both groups, forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and FEV1 / FVC ratio were measured with portable spirometer according to the guidelines of the American Thoracic Society (ATS) and the European Respiratory Society (ERS).
Maximal inspiratory (MIP) and expiratory pressure (MEP) were evaluated with mouth pressure device as per ATS/ERS guidelines.
Sensation of dyspnea was assessed with Modified medical council research scale.
Pectoralis muscle strength were measured isometrically using with digital hand held dynamometer.
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Control group
healthy volunteers selected from the geriatric population
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In both groups, forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and FEV1 / FVC ratio were measured with portable spirometer according to the guidelines of the American Thoracic Society (ATS) and the European Respiratory Society (ERS).
Maximal inspiratory (MIP) and expiratory pressure (MEP) were evaluated with mouth pressure device as per ATS/ERS guidelines.
Sensation of dyspnea was assessed with Modified medical council research scale.
Pectoralis muscle strength were measured isometrically using with digital hand held dynamometer.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Pectoralis muscle strength test
Tidsramme: 15 minute
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The pectoralis muscle strength were measured with handheld dynamometer in supine position.
The shoulder joint of participant was positioned at 90º abducted and at 0º internal/external rotation and the elbow joint was flexed at 90º.
The other shoulder joint was fixed by the physiotherapist.
While the participant performed isometrically horizontal adduction movement, the measurement was performed on the distal part of the upper arm and the contraction was sustained for at least 5 seconds by the participant.
The test was performed three times and with 60 seconds rest between tests.
The mean of the best value on both sides was recorded.
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15 minute
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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FEV1
Tidsramme: 5 minute
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FEV1 value was measured with portable spirometer according to ATS/ ERS guidelines for pulmonary function test.
Results of the measurements were recorded as percentanges of predicted values.
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5 minute
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FVC
Tidsramme: 5 minute
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FVC value was measured with portable spirometer according to ATS/ ERS guidelines for pulmonary function test.
Results of the measurements were recorded as percentanges of predicted values.
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5 minute
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FEV1/FVC
Tidsramme: 5 minute
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The ratio of FEV1/FVC was calculated by measuring device according to measured FEV1 and FVC values
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5 minute
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Respiratory muscle strength test
Tidsramme: 15 minute
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Maximal mouth pressures were measured to evaluate respiratory muscle strength.
The test was performed with mouth pressure device in sitting position.
Participants breathed through a flanged mouthpiece inside the lips at near residual volume for the MIP value and near total lung capacity for MEP value .
The maximum effort was sustained for at least one second.
The test was repeated at least 3 times until no more than 10% difference was present between highest and previous measurements .
The higest value and percentage value of predicted highest value were recorded
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15 minute
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Dyspnea assessment
Tidsramme: 3 minute
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Modified Medical Council Research Dyspnea scale were used to assess sensation of dyspnea
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3 minute
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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: Habibe DURDU, MSc, Giresun University
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
- Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.
- Hirano M, Katoh M, Kawaguchi S, Uemura T. Intrarater reliabilities of shoulder joint horizontal adductor muscle strength measurements using a handheld dynamometer for geriatric and stroke patients. J Phys Ther Sci. 2016 Jan;28(1):51-5. doi: 10.1589/jpts.28.51. Epub 2016 Jan 30.
- Panagiotou M, Polychronopoulos V, Strange C. Respiratory and lower limb muscle function in interstitial lung disease. Chron Respir Dis. 2016 May;13(2):162-72. doi: 10.1177/1479972315626014. Epub 2016 Jan 14.
- Hanada M, Sakamoto N, Ishimatsu Y, Kakugawa T, Obase Y, Kozu R, Senjyu H, Izumikawa K, Mukae H, Kohno S. Effect of long-term treatment with corticosteroids on skeletal muscle strength, functional exercise capacity and health status in patients with interstitial lung disease. Respirology. 2016 Aug;21(6):1088-93. doi: 10.1111/resp.12807. Epub 2016 May 13.
- Durdu H, Yurdalan SU, Ozmen I. Clinical significance of pectoralis muscle strength in elderly patients with idiopathic pulmonary fibrosis. Sarcoidosis Vasc Diffuse Lung Dis. 2022;39(1):e2022009. doi: 10.36141/svdld.v39i1.12094. Epub 2022 Mar 31.
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 (Faktiske)
23. januar 2017
Primær færdiggørelse (Faktiske)
23. juni 2017
Studieafslutning (Faktiske)
23. juni 2017
Datoer for studieregistrering
Først indsendt
13. marts 2021
Først indsendt, der opfyldte QC-kriterier
16. marts 2021
Først opslået (Faktiske)
17. marts 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. marts 2021
Sidst verificeret
1. marts 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pectoralismajor
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
IPD-planbeskrivelse
The data sets collected and analyzed during this study could be provided from corresponding author upon reasonable request
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Idiopatisk lungefibrose
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M.D. Anderson Cancer CenterRekrutteringFibrose | Lymfødem | Fibrosis syndrom | Hoved & amp; HalskræftForenede Stater