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

NCT ID: NCT03092622

Last Updated: 2020-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2019-12-31

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Hypoxia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

exercise training

Outpatients treadmill interval training, 4x4 minutes with 3 minutes in between at lower intensity. 3 sessions weekly for 10 weeks to a total of 30 sessions.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

Exercise training intervention as described earlier.

Interventions

Exercise

Exercise training intervention as described earlier.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Toril A Nagelhus Hernes, phd prof

Role: STUDY_CHAIR

Norwegian University of Science and Technology

Sigurd Steinshamn, md prof

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

St Olavs Hospital, Lungemedisinsk Avdeling & Hjertemedisinsk Avdeling

Trondheim, , Norway

Countries

Norway

Other Identifiers

2013/2129

Identifier Type: -

Identifier Source: org_study_id