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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03092622
Other study ID # 2013/2129
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2017
Est. completion date December 31, 2019

Study information

Verified date January 2020
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise
Exercise training intervention as described earlier.

Locations

Country Name City State
Norway St Olavs Hospital, Lungemedisinsk Avdeling & Hjertemedisinsk Avdeling Trondheim

Sponsors (2)

Lead Sponsor Collaborator
Norwegian University of Science and Technology St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

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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