- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03227341
Pulmonary Rehabilitation in Asthma Control
Does Pulmonary Rehabilitation Contribute to Asthma Control?
Studieoversikt
Detaljert beskrivelse
Asthma treatment is not only medical, it also requires a comprehensive care including nonpharmacological treatment. Pulmonary rehabilitation represents the most important part of the comprehensive care. The investigators aimed to evaluate the efficacy of pulmonary rehabilitation in patients with uncontrolled and partially controlled asthma.
Asthma patients referred to pulmonary rehabilitation (PR) unit were classified according to asthma control test; as partially controlled patients (Group 1), and as uncontrolled patients (Group 2). All patients received of a 8 week pulmonary rehabilitation program. Asthma control tests, pulmonary function tests, arterial blood gases analysis, dyspnea perception, quality of life, exercise capacity, anxiety and depression assessments were performed before and after pulmonary rehabilitation.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Asthmatic patients referred from the outpatient clinic to Pulmonary Rehabilitation unit was confirmed according to GINA guidelines
Exclusion Criteria:
- If the initial diagnosis cannot be confirmed, the patient excluded from the study
- Patients were under medical treatment of -6 months and considered clinically stable.
- Patients with cardiovascular, other lung diseases (pneumoconiosis, pulmonary tuberculosis, interstitial lung disease), or musculoskeletal diseases that would impair exercise training were excluded from the study.
- Also subjects with lack of motivation, poor compliance (not attending the program more than 2 times) or having transport problems were excluded from the study
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: patients with uncontrolled asthma.
8 week pulmonary rehabilitation program
|
8 week exercise program including breathing exercises consisted of pursed-lip breathing, diaphragmatic breathing and thoracic expansion exercises, relaxation and stretching exercises, upper and lower extremity muscle strength training, and aerobic exercises.
In addition, bronchial hygiene techniques and dyspnea-reducing positions
|
|
Annen: patients with partially controlled asthma
8 week pulmonary rehabilitation program
|
8 week exercise program including breathing exercises consisted of pursed-lip breathing, diaphragmatic breathing and thoracic expansion exercises, relaxation and stretching exercises, upper and lower extremity muscle strength training, and aerobic exercises.
In addition, bronchial hygiene techniques and dyspnea-reducing positions
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Asthma control test score
Tidsramme: 4 weeks
|
A test measured the control of asthma
|
4 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Exercise capacity
Tidsramme: 6 minute
|
Six minute walk test
|
6 minute
|
|
Dyspnea
Tidsramme: 1 year
|
MMRC Dyspnea Scale
|
1 year
|
|
Quality of Life
Tidsramme: 1 year
|
St. George Respiratory Questionnaire
|
1 year
|
|
Pulmonary Function Test
Tidsramme: 1 hour
|
FEV1, FVC, DLCO
|
1 hour
|
|
Arterial Blood Gas
Tidsramme: 1 hour
|
PaO2, PaCO2, SaO2
|
1 hour
|
|
Anxiety and Depression
Tidsramme: 1 week
|
Hospital Anxiety and Depression Scale
|
1 week
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KCU123
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