- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01056081
Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease
Inspiratory Muscle Training for Patients With Chronic Obstructive Pulmonary Disease Undergoing a Pulmonary Rehabilitation Program
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Study design: A double-blind parallel controlled trial Setting: outpatient clinic Inclusion criteria: Subjects between 40 and 75 years of age referred by a physician to the Pulmonary Rehabilitation Program, with a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD).
Outcome measurements: Inspiratory muscle strength (using maximal inspiratory pressure, MIP), exercise capacity (using six-minute walk test) and dyspnea were measured.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Subjects with a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
- In a stable condition (without exacerbations or infections for at least a month)
- Had to be former smokers (> 6 months without smoking)
- subjects referred by a physician to the Pulmonary Rehabilitation Program
Exclusion Criteria:
- Subjects with a known history of asthma, or severe and/or unstable heart disease or any other pathological condition that could impair their physical activities
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Inspiratory muscle training
The training was performed using a threshold inspiratory muscle trainer (Respironics HealthScan, Inc, Cedar Grove, New York, USA). The patients performed the IMT training in a seated position, with the upper limbs supported. The total duration of the respiratory training was 30 minutes, with sequences of three minutes of training followed by pauses of two minutes. The initial load was equivalent to 30% of the individual's MIP. This load was progressively increased over the first four weeks, according to the patients' tolerance, to reach 60% of the MIP. This level was then maintained until the end of the training. |
The training was performed using a threshold inspiratory muscle trainer (Respironics HealthScan, Inc, Cedar Grove, New York, USA). The patients performed the IMT training in a seated position, with the upper limbs supported. The total duration of the respiratory training was 30 minutes, with sequences of three minutes of training followed by pauses of two minutes. The initial load was equivalent to 30% of the individual's MIP. This load was progressively increased over the first four weeks, according to the patients' tolerance, to reach 60% of the MIP. This level was then maintained until the end of the training.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Inspiratory muscle strength
Tidsramme: 8 weeks
|
8 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Exercise capacity
Tidsramme: 8 weeks
|
8 weeks
|
Dyspnea
Tidsramme: 8 weeks
|
8 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Silvia R Valderramas, PhD, Evangelical Faculty of Paraná
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
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
- FEPAR 1768
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