Angina PectorisNCT00184444
Effect of Increased Oxygenation in the Air During Endurance Training in Stable Angina Pectoris Patients
A study testing Hypoxic interval training and Normoxic interval training in people with Angina Pectoris, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- Hypoxic interval training and Normoxic interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2004to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable angina pectoris age 18-75
Who cannot join
- unstable angina pectoris
- Limitations to exercise other than coronary artery disease
- Participants in other study interventions
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Angina Pectoris
- Being tested
- Hypoxic interval training, Normoxic interval training
- Keywords
- angina pectoris, hyperoxia, endurance training, stroke volume, cardiac perfusion
- Medical subject headings
- Angina Pectoris, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoxic interval trainingBehavioural
4 x 4 minutes interval training in hypoxic air, 3 times per week at 90-95% HR max
Normoxic interval trainingBehavioural
4 x 4 minutes normoxic interval training, 3 times per week at 90-95% HR max
| Study group | Role | What they receive |
|---|---|---|
| Hypoxic Interval training | Experimental | 4 x 4 minutes interval training with 100% oxygenated air Receives: Behavioral: Hypoxic interval training |
| Normoxic interval training | Experimental | 4 x 4 minutes interval training in normoxic air Receives: Behavioral: Normoxic interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal oxygen uptake
Measured: Baseline and post training
Secondary outcomes (3)
Cardiac perfusion
Measured: Baseline and post training
work economy
Measured: Baseline and post training
cardiac output
Measured: baseline and post training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Asbjørn Støylen, MD, Study director, Norwegian university of sience and technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184444
- Sponsor's protocol ID
- 094-2004
- Status last verified
- Jul 2016
- First submitted
- 15 Sep 2005
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18609057
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Increased Oxygenation in the Air During Endurance Training in Stable Angina Pectoris Patients
- ClinicalTrials.gov ID
- NCT00184444
- Acronym / sponsor ID
- 094-2004
- Conditions
- Angina Pectoris
- Keywords
- angina pectoris, hyperoxia, endurance training, stroke volume, cardiac perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Sep 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypoxic Interval training | Experimental | Behavioral: Hypoxic interval training4 x 4 minutes interval training with 100% oxygenated air |
| Normoxic interval training | Experimental | Behavioral: Normoxic interval training4 x 4 minutes interval training in normoxic air |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stable angina pectoris age 18-75
Key exclusion criteria (3 listed)
- unstable angina pectoris
- Limitations to exercise other than coronary artery disease
- Participants in other study interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoxic interval training4 x 4 minutes interval training in hypoxic air, 3 times per week at 90-95% HR max | Behavioural | Hypoxic Interval training |
| Normoxic interval training4 x 4 minutes normoxic interval training, 3 times per week at 90-95% HR max | Behavioural | Normoxic interval training |
Primary outcome
maximal oxygen uptake
Time frame: Baseline and post training
3 secondary outcomes
Cardiac perfusion
Time frame: Baseline and post training
work economy
Time frame: Baseline and post training
cardiac output
Time frame: baseline and post training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Results publication: PubMed 18609057Karlsen 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.
Related trials for Angina Pectoris
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Active, not recruiting
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
Coronary Microvascular Disease, Ischemic Heart Disease
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
Enrolling by invitationObservational study
Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
Non-obstructive Coronary Disease, Acute or Chronic Coronary Artery Disease
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asbjørn Støylen, MD study director
Norwegian university of sience and technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxic interval training and Normoxic interval training in people with Angina Pectoris, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximal oxygen uptake (time frame: Baseline and post training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00184444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016.