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

NCT03092622 | Completed

• 1 other identifier: 2013/2129
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

Exercise Therapy

Outcome Measures

Primary Outcomes (1)

• Pulmonary artery pressure

  Examined by right heart catheterisation

  Change from baseline at 10 weeks

Other Outcomes (9)

• Cardiac function

  Change from baseline at 10 weeks

• Cardiac function

  Change from baseline at 10 weeks

• Respiratory function

  Change from baseline at 10 weeks

Study Arms (1)

exercise training

EXPERIMENTAL

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

Interventions

Exercise OTHER

Exercise training intervention as described earlier.

exercise training

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

St Olavs Hospital, Lungemedisinsk Avdeling & Hjertemedisinsk Avdeling

Trondheim, Norway

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Hypoxia

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Toril A Nagelhus Hernes, phd prof

  Norwegian University of Science and Technology

  STUDY CHAIR

• Sigurd Steinshamn, md prof

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 28, 2017
• Study Start: April 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)