Clinical trial NCT00218972: Physical Exercise in Hypertension, Randomised Clinical Trial
Official title: Physical Exercise in Hypertension, Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
endurance training
endothelial function
left ventricular function
Echocardiography
Quality of life
Essential hypertension grade 1 - 2
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2005-09-22
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Essential hypertension grade 1 - 2 without medical treatment

Exclusion Criteria:

* End organ damage
* Two or more cardiovascular risk factors
* Diabetes

Primary outcomes:
measure: 24 hour blood pressure
timeFrame: 12 weeks
Secondary outcomes:
measure: Maximum oxygen uptake
timeFrame: 12 weeks
measure: Endothelial function
timeFrame: 12 weeks
measure: Echocardiographic left ventricular function
timeFrame: 12 weeks
measure: Quality of life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Dept. of Circulation and Medical Imaging, Faculty of Medicine, Norwegian University of Science and Technology
name: Asbjorn Stoylen, Dr. Med
role: STUDY_DIRECTOR
References:
citation: 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.