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

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary, Hypoxia

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pulmonary Disease, Chronic Obstructive focused on measuring Exercise Therapy

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St Olavs Hospital, Lungemedisinsk Avdeling & Hjertemedisinsk Avdeling

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

exercise training

Arm Description

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.

Outcomes

Primary Outcome Measures

Pulmonary artery pressure
Examined by right heart catheterisation

Secondary Outcome Measures

Full Information

First Posted
February 22, 2017
Last Updated
January 29, 2020
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03092622
Brief Title
Aerobic Interval Training in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Hypoxemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary, Hypoxia
Keywords
Exercise Therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
exercise training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Exercise training intervention as described earlier.
Primary Outcome Measure Information:
Title
Pulmonary artery pressure
Description
Examined by right heart catheterisation
Time Frame
Change from baseline at 10 weeks
Other Pre-specified Outcome Measures:
Title
Cardiac function
Description
assessed by echocardiography
Time Frame
Change from baseline at 10 weeks
Title
Cardiac function
Description
assessed by right heart catheterisation
Time Frame
Change from baseline at 10 weeks
Title
Respiratory function
Description
assessed by spirometry
Time Frame
Change from baseline at 10 weeks
Title
Respiratory function
Description
assessed by diffusion capacity,
Time Frame
Change from baseline at 10 weeks
Title
Respiratory function
Description
assessed by arterial blood gas
Time Frame
Change from baseline at 10 weeks
Title
Functional capacity
Description
assessed by shuttle walk test
Time Frame
Change from baseline at 10 weeks
Title
Functional capacity
Description
assessed by 6 minute walk test
Time Frame
Change from baseline at 10 weeks
Title
Symptoms
Description
COPD Assessment Test (CAT)
Time Frame
Change from baseline at 10 weeks
Title
Quality of life
Description
St George Respiratory Questionnaire (SGRQ)
Time Frame
Change from baseline at 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toril A Nagelhus Hernes, phd prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sigurd Steinshamn, md prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Olavs Hospital, Lungemedisinsk Avdeling & Hjertemedisinsk Avdeling
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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