Aerobic Interval Training in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Hypoxemia

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03092622
• Other study ID #: 2013/2129
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Hypoxia
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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