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Effect of Increased Oxygenation in the Air During Endurance Training in Stable Angina Pectoris Patients

Primary Purpose

Angina Pectoris

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Hypoxic interval training

Normoxic interval training

About this trial

This is an interventional treatment trial for Angina Pectoris focused on measuring angina pectoris, hyperoxia, endurance training, stroke volume, cardiac perfusion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: stable angina pectoris age 18-75 Exclusion Criteria: unstable angina pectoris Limitations to exercise other than coronary artery disease Participants in other study interventions

Sites / Locations

Norwegian University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Hypoxic Interval training

Normoxic interval training

Arm Description

4 x 4 minutes interval training with 100% oxygenated air

4 x 4 minutes interval training in normoxic air

Outcomes

Primary Outcome Measures

maximal oxygen uptake

Secondary Outcome Measures

Cardiac perfusion

work economy

cardiac output

Full Information

NCT ID

NCT00184444

First Posted

September 15, 2005

Last Updated

July 19, 2016

Sponsor

Norwegian University of Science and Technology

Collaborators

Aarhus University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00184444

Brief Title

Effect of Increased Oxygenation in the Air During Endurance Training in Stable Angina Pectoris Patients

Official Title

Effect of Increased Oxygenation in the Air During Endurance Training in Stable Angina Pectoris Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Norwegian University of Science and Technology

Collaborators

Aarhus University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The study investigates whether endurance training breathing 100% oxygen gives a additional improvement of maximal oxygen uptake in stable Angina Pectoris patients, compared to training without extra oxygen supplementation. In addition work economy, stroke volume and cardiac perfusion is measured. The hypothesis of the study is that increased oxygenation of the air increases performance, stroke volume, work economy and cardiac perfusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Angina Pectoris

Keywords

angina pectoris, hyperoxia, endurance training, stroke volume, cardiac perfusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hypoxic Interval training

Arm Type

Experimental

Arm Description

4 x 4 minutes interval training with 100% oxygenated air

Arm Title

Normoxic interval training

Arm Type

Experimental

Arm Description

4 x 4 minutes interval training in normoxic air

Intervention Type

Behavioral

Intervention Name(s)

Hypoxic interval training

Intervention Description

4 x 4 minutes interval training in hypoxic air, 3 times per week at 90-95% HR max

Intervention Type

Behavioral

Intervention Name(s)

Normoxic interval training

Intervention Description

4 x 4 minutes normoxic interval training, 3 times per week at 90-95% HR max

Primary Outcome Measure Information:

Title

maximal oxygen uptake

Time Frame

Baseline and post training

Secondary Outcome Measure Information:

Title

Cardiac perfusion

Time Frame

Baseline and post training

Title

work economy

Time Frame

Baseline and post training

Title

cardiac output

Time Frame

baseline and post training

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: stable angina pectoris age 18-75 Exclusion Criteria: unstable angina pectoris Limitations to exercise other than coronary artery disease Participants in other study interventions

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Asbjørn Støylen, MD

Organizational Affiliation

Norwegian university of sience and technology

Official's Role

Study Director

Facility Information:

Facility Name

Norwegian University of Science and Technology

City

Trondheim

ZIP/Postal Code

7489

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

18609057

Citation

Karlsen T, Hoff J, Stoylen A, Skovholdt MC, Gulbrandsen Aarhus K, Helgerud J. Aerobic interval training improves VO2 peak in coronary artery disease patients; no additional effect from hyperoxia. Scand Cardiovasc J. 2008 Oct;42(5):303-9. doi: 10.1080/14017430802032723.

Results Reference

result

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Effect of Increased Oxygenation in the Air During Endurance Training in Stable Angina Pectoris Patients

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