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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 45 Years - 90 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03092622
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Norwegian University of Science and Technology
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Toril A Nagelhus Hernes, phd profSigurd Steinshamn, md prof
Principal Investigator Affiliation Norwegian University of Science and TechnologyNorwegian University of Science and Technology
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries Norway
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary, Hypoxia
Arms & Interventions

Arms

Experimental: 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.

Interventions

Other: - Exercise

Exercise training intervention as described earlier.

Contact a Trial Team

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International Sites

Trondheim, Norway

Status

Address

St Olavs Hospital, Lungemedisinsk Avdeling & Hjertemedisinsk Avdeling

Trondheim, ,

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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