Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
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
Verified date | January 2020 |
Source | Norwegian University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 90 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Norway | St Olavs Hospital, Lungemedisinsk Avdeling & Hjertemedisinsk Avdeling | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology | St. Olavs Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cardiac function | assessed by echocardiography | Change from baseline at 10 weeks | |
Other | Cardiac function | assessed by right heart catheterisation | Change from baseline at 10 weeks | |
Other | Respiratory function | assessed by spirometry | Change from baseline at 10 weeks | |
Other | Respiratory function | assessed by diffusion capacity, | Change from baseline at 10 weeks | |
Other | Respiratory function | assessed by arterial blood gas | Change from baseline at 10 weeks | |
Other | Functional capacity | assessed by shuttle walk test | Change from baseline at 10 weeks | |
Other | Functional capacity | assessed by 6 minute walk test | Change from baseline at 10 weeks | |
Other | Symptoms | COPD Assessment Test (CAT) | Change from baseline at 10 weeks | |
Other | Quality of life | St George Respiratory Questionnaire (SGRQ) | Change from baseline at 10 weeks | |
Primary | Pulmonary artery pressure | Examined by right heart catheterisation | Change from baseline at 10 weeks |
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