The Efficacy of Pulmonary Rehabilitation Exercise in Home Care for the Non-invasive Ventilator-dependent Elderly With COPD
7. september 2017 oppdatert av: Kaohsiung Medical University Chung-Ho Memorial Hospital
The Efficacy of Pulmonary Rehabilitation Exercise in Home Care for the Non-invasive Ventilator-dependent Elderly With Chronic Obstructive Pulmonary Disease
Pulmonary rehabilitation exercise is beneficial for individuals with chronic obstructive pulmonary disease (COPD).
However, merely 30% patients know how to do the exercise correctly.
Therefore, it is worthy to investigate the applications in clinical practice.
In addition, there are no relative research in Taiwan to see effects of an 8-week pulmonary rehabilitation exercise in home care for the non-invasive ventilator-dependent elderly with COPD.
Studieoversikt
Detaljert beskrivelse
According to estimation of the world health organization (WHO), chronic obstructive pulmonary disease (COPD) would become the third major cause of death.
Moreover, the lung recovery exercise is proven beneficial for mild, moderate, or severe COPD by the guideline of GOLD.
However, research in Taiwan focused on follow-up medical status for mild or moderate COPD in clinics, or weaning of severe COPD in intensive care unit (ICU).
There was no relative research investigating non-invasive ventilator-dependent elderly with COPD on home care.
Therefore, this study would explore effects of pulmonary rehabilitation exercise for this group.
The pulmonary rehabilitation exercise program in this study is divided into two stages in the experimental group.
The first four weeks, 10 minutes for each training (upper extremity without loading, exercise of lower extremity, and respiratory muscles), and totally 30 minutes is required.
Consequent four weeks, 15 minutes for upper extremity without loading, 15 minutes for exercise of lower extremity, and 10 minutes for training of respiratory muscles, and totally 40 minutes is scheduled.
Studietype
Intervensjonell
Registrering (Faktiske)
28
Fase
- Ikke aktuelt
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
20 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- age > 65 y/o, and is diagnosed with COPD;
- is non-invasive ventilator-dependent in home care;
- is stable evaluated by a doctor;
- is conscious clear and can perform the exercise (upper, lower extremity, and respiratory muscle training);
- do not accept exercise training as (4)-mentioned currently
Exclusion Criteria:
- conscious is not clear enough to perform the exercise training;
- cannot leave his/her bed independently;
- cannot wean a ventilator and need to use for 24 hours;
- severe heart disease (eg. acute myocardial infarction, severe arrhythmia);
- Oxygen saturation (SPO2) lower than 90% during oxygen therapy
- fever or acute infections
- reject to sign consent form
- age < 20 y/o
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Regular education
Regular education for COPD, including percussion and posture drainage.
|
|
|
Eksperimentell: Exercise
Besides the same information for the education group, exercise of upper extremity without loading, exercise of lower extremity, and training of respiratory muscles are used for the exercise group.
|
Besides the same information for the education group, exercise of upper extremity without loading, exercise of lower extremity, and training of respiratory muscles are used for the exercise group
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
changed strength of respiratory muscles
Tidsramme: baseline , 8 weeks, 12 weeks
|
inspforce(BUEHRINGER.USA)
|
baseline , 8 weeks, 12 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
changed lung function
Tidsramme: baseline , 8 weeks, 12 weeks
|
spirometry
|
baseline , 8 weeks, 12 weeks
|
|
changed value for quality of life
Tidsramme: baseline , 8 weeks, 12 weeks
|
ST.George's Respiratory Questionnaire
|
baseline , 8 weeks, 12 weeks
|
|
changed score of intensity of dyspnea
Tidsramme: baseline , 8 weeks, 12 weeks
|
Borg dyspnoea scale
|
baseline , 8 weeks, 12 weeks
|
|
time of weaning from ventilator
Tidsramme: baseline , 8 weeks, 12 weeks
|
time of using ventilator data is directed recorded continually by chip of his/her ventilator during the study
|
baseline , 8 weeks, 12 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Miao-Ju Hsu, PHD, 100,Shih-Chuan 1st Road,Kaohsiung,80708,Taiwan
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 (Faktiske)
4. desember 2015
Primær fullføring (Faktiske)
26. juli 2016
Studiet fullført (Faktiske)
26. september 2016
Datoer for studieregistrering
Først innsendt
1. juli 2016
Først innsendt som oppfylte QC-kriteriene
18. juli 2016
Først lagt ut (Anslag)
19. juli 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. september 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. september 2017
Sist bekreftet
1. september 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KMUHIRB-E(I)-20150203
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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