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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypoxia; Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary
• Intervention / Treatment: Other: Exercise

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St Olavs Hospital, Lungemedisinsk Avdeling & Hjertemedisinsk Avdeling

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Exercise; Exercise training intervention as described earlier.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary artery pressure	Examined by right heart catheterisation	Change from baseline at 10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac function	assessed by echocardiography	Change from baseline at 10 weeks
Cardiac function	assessed by right heart catheterisation	Change from baseline at 10 weeks
Respiratory function	assessed by spirometry	Change from baseline at 10 weeks
Respiratory function	assessed by diffusion capacity,	Change from baseline at 10 weeks
Respiratory function	assessed by arterial blood gas	Change from baseline at 10 weeks
Functional capacity	assessed by shuttle walk test	Change from baseline at 10 weeks
Functional capacity	assessed by 6 minute walk test	Change from baseline at 10 weeks
Symptoms	COPD Assessment Test (CAT)	Change from baseline at 10 weeks
Quality of life	St George Respiratory Questionnaire (SGRQ)	Change from baseline at 10 weeks

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital
• Investigators: Study Chair: Toril A Nagelhus Hernes, phd prof, Norwegian University of Science and Technology; Principal Investigator: Sigurd Steinshamn, md prof, Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: March 27, 2017
• First Posted (Actual): March 28, 2017

Study Record Updates

• Last Update Posted (Actual): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Exercise Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Hypertension; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Hypoxia
• Other Study ID Numbers: 2013/2129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No