Clinical trial NCT03092622: Aerobic Interval Training in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Hypoxemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Hypertension, Pulmonary
Hypoxia
Keywords: Exercise Therapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2017-03-28
Enrollment: 16
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pulmonary artery pressure
timeFrame: Change from baseline at 10 weeks
Secondary outcomes:
Other outcomes:
measure: Cardiac function
timeFrame: Change from baseline at 10 weeks
measure: Cardiac function
timeFrame: Change from baseline at 10 weeks
measure: Respiratory function
timeFrame: Change from baseline at 10 weeks
measure: Respiratory function
timeFrame: Change from baseline at 10 weeks
measure: Respiratory function
timeFrame: Change from baseline at 10 weeks
measure: Functional capacity
timeFrame: Change from baseline at 10 weeks
measure: Functional capacity
timeFrame: Change from baseline at 10 weeks
measure: Symptoms
timeFrame: Change from baseline at 10 weeks
measure: Quality of life
timeFrame: Change from baseline at 10 weeks
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital, Lungemedisinsk Avdeling & Hjertemedisinsk Avdeling
Study officials:
affiliation: Norwegian University of Science and Technology
name: Toril A Nagelhus Hernes, phd prof
role: STUDY_CHAIR
affiliation: Norwegian University of Science and Technology
name: Sigurd Steinshamn, md prof
role: PRINCIPAL_INVESTIGATOR
References: