- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01783808
Intervention Study to Investigate Supplemental Oxygen in COPD
Effects on Exercise Capacity, Physical Activity and Quality of Life Using Ambulatory Oxygen in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Desaturate Only During Exercise
The purpose of this trial is to study the effects on exercise capacity, physical activity, inflammatory markers and quality of life of supplemental ambulatory oxygen, to be used during physical activity, in patients with COPD who are normoxic at rest but hypoxemic during a six-min walk test.
Our hypothesis is that if patients are able to use supplemental oxygen they will be more physically active and thereby improve health related quality of life.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Study design The study will employ a parallel design for 6 months including 144 patients (72 patients/group). Patients will be randomized to intervention or control group. The intervention comprises supplemental oxygen to be used during physical activity for 6 months. The control group will receive the same physical activity instructions as the intervention group during the 6 months, but they will not be able to use supplemental oxygen during physical activity.
The study will be a prospective, randomized, single-blind multi-centre intervention study with an intention to treat design (last value carry over). Inclusion will continue until 144 patients have fulfilled the 6 months. Patients will be tested at baseline and after 6 months. There will also be a follow-up after 12 months comprising questionnaires. The study will include centers in Sweden Norway, Finland, and Estonia.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Margareta I Emtner, PhD
- Telefonnummer: +46184714761
- E-mail: margareta.emtner@neuro.uu.se
Undersøgelse Kontakt Backup
- Navn: Karin Wadell, PhD
- Telefonnummer: +4690786 9887
- E-mail: karin.wadell@physiother.umu.se
Studiesteder
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Uppsala, Sverige, 751 85
- Rekruttering
- Akademiska Sjukhuset
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Kontakt:
- Margareta I Emtner, PhD
- Telefonnummer: +46184714761
- E-mail: margareta.emtner@neuro.uu.se
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Kontakt:
- Christer Janson, Professor
- Telefonnummer: +46186114115
- E-mail: christer.janson@medsci.uu.se
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Ledende efterforsker:
- Margareta I Emtner, PhD
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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:
- COPD, Arterial Oxygen Saturation > 8 kilopascal at rest
- Oxygen Saturation ≤ 88% and a fall in Oxygen Saturation ≥ 4% during a six-minute walk test in ambient air
- No exacerbation within 4 weeks prior to the study
- Post-bronchodilator forced expiratory volume at one second < 80% predicted and forced expiratory volume at one second /Vital capacity < 0.7
- Oxygen Saturation ≥ 92 % during a walk test in self-selected pace with supplemental oxygen. Patients should use supplemental oxygen 10 minutes before the test starts.
- Non-smoker (smoke free for ≥ 6 months)
- Interest in being physically active
Exclusion Criteria:
- Arterial carbon dioxide > 6.5 kilopascal at rest
- Orthopedic, neurologic or mental impairments that would limit physical activity
- Neoplastic disease that is anticipated to influence survival
- Patients exercising with supplemental oxygen
- Long-term oxygen therapy
- Patients with arterial auricular fibrillation and/or heart disease that might hinder physical activity as judged by the physician
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Supplemental oxygen
Patients are supposed to use ambulatory supplemental oxygen during physical activity. The intervention will last for six months. In addition to supplemental oxygen the patients will be stimulated by a physiotherapist to be more physically active. A behavioural medicine intervention will be used. |
Patients are supposed to use ambulatory supplemental oxygen during physical activity. The intervention will last for six months. In addition to supplemental oxygen the patients will be stimulated by a physiotherapist to be more physically active. A behavioural medicine intervention will be used. |
Ingen indgriben: Control group
The control group will not get supplemental oxygen during physical activity but they will get the same physical activity intervention as the intervention group.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Six-minute walk test
Tidsramme: Change from baseline to 6 months
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The patient is supposed to walk as long as possible during six minutes.
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Change from baseline to 6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Physical activity level
Tidsramme: Change from baseline to 6 months
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Physical activity will be measured with an activity monitor (accelerometer) and by a questionnaire
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Change from baseline to 6 months
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Health related quality of life
Tidsramme: Change from baseline to six months
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EuroQol five-dimension questionnaire, St Georges Respiratory Questionnaire, Hospital Anxiety and Depression Scale, COPD Assessment Test, Medical Research Council scale
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Change from baseline to six months
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Inflammatory markers
Tidsramme: Change from baseline to 6 months
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C-reactive protein, Leucocytes, Thrombocytes, Erythrocytes, Hemoglobin
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Change from baseline to 6 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Christer Janson, Professor, Department of Medical Sciences, Uppsala University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Ambox-2012-MEUP
- Uppsala University (Uppsala Ethical Review board)
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