- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03086590
EVALUATION OF RESPIRATORY MECHANICS AND FUNCTIONALITY IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
5. november 2018 opdateret af: Rodrigo Viana Correia de Souza, Universidade Federal de Pernambuco
BODY COMPOSITION, PERIPHERAL MUSCULAR FORCE, KINEMATIC THORACIC-ABDOMINAL, VENTILATORY METABOLIC RESPONSE, DIAPHRAGM MOBILITY AND THICKNESS PREDICTION OF OBSTRUCTION LEVEL OF COPD?
To associate a lean mass, peripheral muscle strength, kinematic thoracic-abdominal, respiratory metabolic response, mobility and diaphragmatic thickness, verifying its relation with the obstruction level of COPD
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Individuals with COPD present restriction in their daily lives due to changes and bodily disorders promoted by the disease, such as changes in types of muscle fibers and chronic inflammatory process, causing a low level of physical activity and quality of life, besides being closely Related to the need for hospitalizations and increased mortality.
A cross-sectional study with a convenience sample was performed at the Laboratory of Cardiopulmonary Physiotherapy of the Federal University of Pernambuco during the period from December 2016 to February 2018.
As measurements of body composition were performed with a bio-balance scale, Evaluation of the peripheral muscle strength will be used the dynamometer, a load cell and electromyography, a kinematic thoracic-abdominal will be measured by optoelectronic plethysmography, a respiratory metabolic response will be verified during the 6-minute walk test using the gas analyzer, and for evaluation of mobility and diaphragmatic thickness are used on ultrasound associated with pneumotachograph.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
20
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Pernambuco
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Recife, Pernambuco, Brasilien, 50670-901
- Universidade Federal de Pernambuco
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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
21 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients diagnosed with Chronic Obstructive Pulmonary Disease, selected at the Hospital das Clínicas of the Federal University of Pernambuco, Hospital Otávio de Freitas and Pharmacy of the State of Pernambuco.
Beskrivelse
Inclusion Criteria:
- Young adults, adults and elderly subjects
Exclusion Criteria:
- Others respiratory diseases;
- Heart diseases;
- Those who are in some previous training program or rehabilitation;
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Group 1
COPD mild.
The individuals allocated to this group have FEV1 ≥ 80% predicted.
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Group 2
COPD Moderate.
The individuals allocated to this group have 50% ≤ FEV1 < 80% predicted.
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Group 3
COPD Severe.
The individuals allocated to this group have 30% ≤ FEV1 < 50% predicted.
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Group 4
COPD Very severe.
The individuals allocated to this group have FEV1 < 30% predicted.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Fat-free mass
Tidsramme: Baseline
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Mass of the human body disregarding fat.
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Baseline
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Quadriceps Force
Tidsramme: Baseline
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Quadriceps muscle strength measured during maximum voluntary contraction.
|
Baseline
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Handgrip strength
Tidsramme: Baseline
|
Maximum voluntary manual holding force.
|
Baseline
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Total chest wall volume
Tidsramme: Baseline
|
Total volume resulting from the sum of the volume of the pulmonary compartment of the costal, abdominal gradient of the costal and abdominal beds.
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Baseline
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Oxygen uptake
Tidsramme: Baseline
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Consumption of oxygen during an effort.
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Baseline
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Diaphragm mobility
Tidsramme: Baseline
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It is the diaphragmatic movement from the end of the expiration until the end of the inspiration, being able to be realized in tidal volume or starting from the total pulmonary capacity.
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Baseline
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Diaphragm thickness
Tidsramme: Baseline
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Defined as a corpulence of the diaphragm muscle
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Baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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)
1. november 2016
Primær færdiggørelse (Faktiske)
1. februar 2018
Studieafslutning (Faktiske)
1. marts 2018
Datoer for studieregistrering
Først indsendt
9. marts 2017
Først indsendt, der opfyldte QC-kriterier
15. marts 2017
Først opslået (Faktiske)
22. marts 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. november 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. november 2018
Sidst verificeret
1. november 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UFPE-M1
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .