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Completed

NCT Number: NCT03092622

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Cardiovascular Diseases Chronic Disease Disease Attributes Hypertension Hypertension, Pulmonary Hypoxia Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

45 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital, Lungemedisinsk Avdeling & Hjertemedisinsk Avdeling

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

Exercise training intervention as described earlier.

Primary outcomes

  1. Pulmonary artery pressure

    Time frame: Change from baseline at 10 weeks

    Examined by right heart catheterisation

Other outcomes

  1. Cardiac function

    Time frame: Change from baseline at 10 weeks

    assessed by echocardiography

  2. Cardiac function

    Time frame: Change from baseline at 10 weeks

    assessed by right heart catheterisation

  3. Respiratory function

    Time frame: Change from baseline at 10 weeks

    assessed by spirometry

  4. Respiratory function

    Time frame: Change from baseline at 10 weeks

    assessed by diffusion capacity,

  5. Respiratory function

    Time frame: Change from baseline at 10 weeks

    assessed by arterial blood gas

  6. Functional capacity

    Time frame: Change from baseline at 10 weeks

    assessed by shuttle walk test

  7. Functional capacity

    Time frame: Change from baseline at 10 weeks

    assessed by 6 minute walk test

  8. Symptoms

    Time frame: Change from baseline at 10 weeks

    COPD Assessment Test (CAT)

  9. Quality of life

    Time frame: Change from baseline at 10 weeks

    St George Respiratory Questionnaire (SGRQ)

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 28, 2017
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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