- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03092622
Aerobic Interval Training in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Hypoxemia
Effects of Aerobic Interval Training on Cardiac Function, With Special Focus on Pulmonary Pressures and Right Sided Function, in Patients With Chronic Obstructive Pulmonary Disease and Hypoxemia
Patients with severe Chronic Obstructive Pulmonary Disease (COPD) and low oxygen levels in the blood are at risk of developing pulmonary hypertension and strain on the right side of the heart, both of which are known to increase symptoms and worsen prognosis It is not fully established whether interval exercise training in patients with severe COPD and concomitant low oxygen levels is beneficial.
This study aims to evaluate the effects of aerobic interval exercise training in patients with severe COPD and low oxygen levels in the blood, with a particular emphasis on such effects on the cardiovascular system and pulmonary circulation.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Trondheim, Norge
- St Olavs Hospital, Lungemedisinsk Avdeling & Hjertemedisinsk Avdeling
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Chronic Obstructive Pulmonary Disease (COPD)
- Forced Expiratory Volume 1 second (FEV1) <60% of predicted
- FEV1%FVC <70 % of predicted (FVC = Forced Vital Capacity)
- Qualify for Long term oxygen therapy (LTOT), or presence of significant desaturation on exercise.
Exclusion Criteria:
- Unstable ischaemic heart disease or valvular heart disease.
- Active malignant disease.
- Substance abuse.
- Physical or mental disability that prevents participation in the exercise programme or testing.
- Pregnancy.
- Exacerbation of COPD or respiratory tract infection last 6 weeks before.
- Completed pulmonary rehabilitation programme or other organised exercise programme last 3 month
- Use of high doses of systemic steroids.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: exercise training
Outpatients treadmill interval training, 4x4 minutes with 3 minutes in between at lower intensity.
3 sessions weekly for 10 weeks to a total of 30 sessions.
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Exercise training intervention as described earlier.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pulmonary artery pressure
Tidsramme: Change from baseline at 10 weeks
|
Examined by right heart catheterisation
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Change from baseline at 10 weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Cardiac function
Tidsramme: Change from baseline at 10 weeks
|
assessed by echocardiography
|
Change from baseline at 10 weeks
|
Cardiac function
Tidsramme: Change from baseline at 10 weeks
|
assessed by right heart catheterisation
|
Change from baseline at 10 weeks
|
Respiratory function
Tidsramme: Change from baseline at 10 weeks
|
assessed by spirometry
|
Change from baseline at 10 weeks
|
Respiratory function
Tidsramme: Change from baseline at 10 weeks
|
assessed by diffusion capacity,
|
Change from baseline at 10 weeks
|
Respiratory function
Tidsramme: Change from baseline at 10 weeks
|
assessed by arterial blood gas
|
Change from baseline at 10 weeks
|
Functional capacity
Tidsramme: Change from baseline at 10 weeks
|
assessed by shuttle walk test
|
Change from baseline at 10 weeks
|
Functional capacity
Tidsramme: Change from baseline at 10 weeks
|
assessed by 6 minute walk test
|
Change from baseline at 10 weeks
|
Symptoms
Tidsramme: Change from baseline at 10 weeks
|
COPD Assessment Test (CAT)
|
Change from baseline at 10 weeks
|
Quality of life
Tidsramme: Change from baseline at 10 weeks
|
St George Respiratory Questionnaire (SGRQ)
|
Change from baseline at 10 weeks
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Toril A Nagelhus Hernes, phd prof, Norwegian University of Science and Technology
- Ledende efterforsker: Sigurd Steinshamn, md prof, Norwegian University of Science and Technology
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2013/2129
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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