HypertensionNCT00218972
Physical Exercise in Hypertension, Randomised Clinical Trial
A study testing Aerobic interval training, moderate intensity training and Recommendation of regular exercise in people with Hypertension, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Endurance training has a documented effect on hypertension. However, only low to moderate training intensity has so far been studied. High aerobic intensity should, from physiological considerations, prove more effective in also reducing high blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Aerobic interval training, moderate intensity training and Recommendation of regular exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2005to Dec 2008
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Essential hypertension grade 1 - 2 without medical treatment
Who cannot join
- End organ damage
- Two or more cardiovascular risk factors
- Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Endurance training has a documented effect on hypertension. However, only low to moderate training intensity has so far been studied. High aerobic intensity should, from physiological considerations, prove more effective in also reducing high blood pressure. The present study is a randomised comparison of high versus moderate intensity versus training in groups, and general advice on 24 hour blood pressure in hypertensives. The training period is 12 weeks, with follow-up after 1 year. Maximum oxygen uptake, quality of life, left ventricular function and blood vessel reactivity are also measured.
Read the detailed description
Endurance training has documented effect on blood pressure in hypertension. However, only low to moderate training intensity has so far been studied. Higher aerobic intensity based on individual measurements of maximum oxygen uptake is more efficient in increasing oxygen uptake, and might prove more effective in lowering blood pressure. Group training, on the other hand is not individualised, but less personnel required and may prove more cost effective. Endurance training is shown to improve both systolic and diastolic left ventricular function, as well as endothelial function. Both can be measured non-invasively by ultrasound.
The study is an open, randomised study with four arms, comparing:
- High aerobic intensity interval training
- Moderate aerobic intensity training
- Group training
- Controls receiving standard advice on lifestyle and training
Training effect is measured by Max. Oxygen uptake, blood pressure by continuous 24 hour ambulatory measurement, Left ventricular function by echo Doppler and endothelial function by flow mediated vasodilation by ultrasound.
The effect of exercise on blood pressure is dependent on continued training. All patients will be followed up after one year.
- Conditions
- Hypertension
- Being tested
- Aerobic interval training, moderate intensity training, Recommendation of regular exercise
- Keywords
- Hypertension, endurance training, endothelial function, left ventricular function, Echocardiography, Quality of life, Essential hypertension grade 1 - 2
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic interval trainingBehavioural
moderate intensity trainingBehavioural
Recommendation of regular exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| AIT: aerobic interval training | Active comparator | High intensity interval training on treadmill at > 90% of maximal HR for four bouts of four minutes with warm up, active pauses and cool down, three times per week for 12 weeks. Receives: Behavioral: Aerobic interval training |
| MIT, moderate intensity training | Active comparator | Moderate intensity treadmill continuous exercise at 70% of maximum heart rate for 47 minutes (in order to ensure isocaloric training amount), three times per week for 12 weeks. Receives: Behavioral: moderate intensity training |
| Recommendation of regular exercise | Active comparator | No training intervention, general advice as prescribed in guidelines. Receives: Behavioral: Recommendation of regular exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour blood pressure
Measured: 12 weeks
Secondary outcomes (4)
Maximum oxygen uptake
Measured: 12 weeks
Endothelial function
Measured: 12 weeks
Echocardiographic left ventricular function
Measured: 12 weeks
Quality of life
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionSep 2008
- Study completionDec 2008
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 HypertensionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Asbjorn Stoylen, Dr. Med, Study director, Dept. of Circulation and Medical Imaging, Faculty of Medicine, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218972
- Sponsor's protocol ID
- Traininghypertension
- Status last verified
- Dec 2013
- First submitted
- 20 Sep 2005
- Last updated
- 6 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Molmen-Hansen HE, Stolen T, Tjonna AE, Aamot IL, Ekeberg IS, Tyldum GA, Wisloff U, Ingul CB, Stoylen A. Aerobic interval training reduces blood pressure and improves myocardial function in hypertensive patients. Eur J Prev Cardiol. 2012 Apr;19(2):151-60. doi: 10.1177/1741826711400512. Epub 2011 Mar 4.
PubMed 21450580
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise in Hypertension, Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT00218972
- Acronym / sponsor ID
- Traininghypertension
- Conditions
- Hypertension
- Keywords
- Hypertension, endurance training, endothelial function, left ventricular function, Echocardiography, Quality of life, Essential hypertension grade 1 - 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Feb 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 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.
Endurance training has a documented effect on hypertension. However, only low to moderate training intensity has so far been studied. High aerobic intensity should, from physiological considerations, prove more effective in also reducing high blood pressure. The present study is a randomised comparison of high versus moderate intensity versus training in groups, and general advice on 24 hour blood pressure in hypertensives. The training period is 12 weeks, with follow-up after 1 year. Maximum oxygen uptake, quality of life, left ventricular function and blood vessel reactivity are also measured.
Detailed description
Endurance training has documented effect on blood pressure in hypertension. However, only low to moderate training intensity has so far been studied. Higher aerobic intensity based on individual measurements of maximum oxygen uptake is more efficient in increasing oxygen uptake, and might prove more effective in lowering blood pressure. Group training, on the other hand is not individualised, but less personnel required and may prove more cost effective. Endurance training is shown to improve both systolic and diastolic left ventricular function, as well as endothelial function. Both can be measured non-invasively by ultrasound.
The study is an open, randomised study with four arms, comparing:
- High aerobic intensity interval training
- Moderate aerobic intensity training
- Group training
- Controls receiving standard advice on lifestyle and training
Training effect is measured by Max. Oxygen uptake, blood pressure by continuous 24 hour ambulatory measurement, Left ventricular function by echo Doppler and endothelial function by flow mediated vasodilation by ultrasound.
The effect of exercise on blood pressure is dependent on continued training. All patients will be followed up after one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AIT: aerobic interval training | Active comparator | Behavioral: Aerobic interval trainingHigh intensity interval training on treadmill at > 90% of maximal HR for four bouts of four minutes with warm up, active pauses and cool down, three times per week for 12 weeks. |
| MIT, moderate intensity training | Active comparator | Behavioral: moderate intensity trainingModerate intensity treadmill continuous exercise at 70% of maximum heart rate for 47 minutes (in order to ensure isocaloric training amount), three times per week for 12 weeks. |
| Recommendation of regular exercise | Active comparator | Behavioral: Recommendation of regular exerciseNo training intervention, general advice as prescribed in guidelines. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Essential hypertension grade 1 - 2 without medical treatment
Key exclusion criteria (3 listed)
- End organ damage
- Two or more cardiovascular risk factors
- Diabetes
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 |
|---|---|---|
| Aerobic interval training | Behavioural | AIT: aerobic interval training |
| moderate intensity training | Behavioural | MIT, moderate intensity training |
| Recommendation of regular exercise | Behavioural | Recommendation of regular exercise |
Primary outcome
24 hour blood pressure
Time frame: 12 weeks
4 secondary outcomes
Maximum oxygen uptake
Time frame: 12 weeks
Endothelial function
Time frame: 12 weeks
Echocardiographic left ventricular function
Time frame: 12 weeks
Quality of life
Time frame: 12 weeks
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 6 Dec 2013.
- Results publication: PubMed 21450580Molmen-Hansen HE, Stolen T, Tjonna AE, Aamot IL, Ekeberg IS, Tyldum GA, Wisloff U, Ingul CB, Stoylen A. Aerobic interval training reduces blood pressure and improves myocardial function in hypertensive patients. Eur J Prev Cardiol. 2012 Apr;19(2):151-60. doi: 10.1177/1741826711400512. Epub 2011 Mar 4.
Related trials for Hypertension
RecruitingPhase 4
Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients
Pulmonary Arterial Hypertension
Not yet recruiting
Effects of Smartphone Use and Television Viewing on Standardized BP Measurement: The SCREENS-BP Study
Hypertension
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
RecruitingPhase 4
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
RecruitingPhase 2
Spironolactone for Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
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.
Asbjorn Stoylen, Dr. Med study director
Dept. of Circulation and Medical Imaging, Faculty of Medicine, Norwegian University of Science 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 Aerobic interval training, moderate intensity training and Recommendation of regular exercise in people with Hypertension, 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 6 Dec 2013. 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?
24 hour blood pressure (time frame: 12 weeks). 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 NCT00218972, 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 6 Dec 2013.