- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02329873
Respiratory Rehabilitation Exercises in Older Adults With Acute Exacerbations of Chronic Obstructive Pulmonary Disease
30. december 2014 opdateret af: Lin-Yu Liao, Chest Hospital, Ministry of Health and Welfare, Taiwan
Efficacy of the Respiratory Rehabilitation Exercise Training Package in Hospitalized Elderly Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease: Randomized Control Trial
The purpose of this randomized controlled trial was to evaluate the effects of a respiratory rehabilitation exercise training package on dyspnea, cough, exercise tolerance, and sputum expectoration of hospitalized elderly patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD).
Using purposive sampling, 61 participants were recruited and randomly assigned to either the experimental group (n = 30) or the control group (n = 31).
The experimental group participants received the respiratory rehabilitation exercise training twice a day and 10-30 minutes per session for four days.
The control group participants received usual care and health education.
Data were collected at baseline and at the end of the four-day intervention.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The respiratory rehabilitation exercise training package included: (a) Disease awareness: The doctor explained the disease to patients and their families through the chest X-ray, (b) Sputum clearance treatments: Easily understood postural drainage cards were provided to the patients and families to assist with proper sputum clearance procedures, (c) Pursed lip breathing training: Devices were provided to the patients to ensure that the breathing exercises were completed properly, (d) Upper-limb exercise with breathing pranayama: Towels were provided to the patients to assist with upper-limb exercises properly, (e) Walking training with breathing pranayama: Legs were elevated while inhaling, and returned to the position while exhaling, and (f) Assign a pulmonary rehabilitation program coordinator: Coordinators were assigned to assist the patients in nutrition management and health education.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
61
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Kaohsiung, Taiwan, 71742
- Chest Hospital, Ministry of Health and Welfare
-
-
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 og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion criteria:
- diagnosed with moderate COPD with moderate acute exacerbation
- over 65 years of age
- conscious clear
- with shortness of breath or dyspnea that was not caused by heart disease, pneumothorax, or pulmonary edema
- had received bronchodilator aerosol therapy or antibiotic treatment, but had not been treated with an antitussive
Exclusion Criteria:
- unstable vital signs
- blood oxygen concentration lower than 90%
- unstable psychological status, hemoptysis, pneumothorax, pulmonary edema, or using the respirator
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Experimental group
Respiratory rehabilitation exercise training 2 times/day, 10-30 minutes per session for 4 days.
|
The respiratory rehabilitation exercise training package was conducted twice a day and 10-30 minutes per session for 4 days: (a) disease awareness, (b) sputum clearance treatments, (c) pursed lip breathing training, (d) upper-limb exercise with breathing pranayama, (e) walking training with breathing pranayama, and (f) assign a pulmonary rehabilitation program coordinator.
Andre navne:
|
|
Ingen indgriben: Control group
Control group received usual care and health education.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in dyspnea at 4th day
Tidsramme: At baseline and at the 4th day of the study
|
Measured by the Borg Rating of Perceived Exertion Scale.
|
At baseline and at the 4th day of the study
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in cough severity at 4th day
Tidsramme: At baseline and at the 4th day of the study
|
Measured by the visual analog scale.
|
At baseline and at the 4th day of the study
|
|
Change from baseline in exercise tolerance at 4th day
Tidsramme: At baseline and at the 4th day of the study
|
Measured by the 6-minute walk distance
|
At baseline and at the 4th day of the study
|
|
Change from baseline in sputum expectoration at 4th day
Tidsramme: At baseline and at the 4th day of the study
|
Assessed by recording the patients' feelings regarding sputum expectoration during the previous day.
|
At baseline and at the 4th day of the study
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Lin-Yu Liao, MS, Chest Hospital, Ministry of Health and Welfare, Taiwan
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.
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
1. november 2011
Primær færdiggørelse (Faktiske)
1. december 2012
Studieafslutning (Faktiske)
1. december 2012
Datoer for studieregistrering
Først indsendt
15. december 2014
Først indsendt, der opfyldte QC-kriterier
30. december 2014
Først opslået (Skøn)
1. januar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. januar 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. december 2014
Sidst verificeret
1. december 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ER-100-202
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 .