Physical Exercise in Hypertension, Randomised Clinical Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Physical Exercise in Hypertension, Randomised Clinical Trial

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Aerobic interval training
* Behavioral: moderate intensity training
* Behavioral: Recommendation of regular exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Essential hypertension grade 1 - 2 without medical treatment Exclusion Criteria: End organ damage Two or more cardiovascular risk factors Diabetes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AIT: aerobic interval training<br>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. | Behavioral: Aerobic interval training<br> <br> |
| Active Comparator: MIT, moderate intensity training<br>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. | Behavioral: moderate intensity training<br> <br> |
| Active Comparator: Recommendation of regular exercise<br>No training intervention, general advice as prescribed in guidelines. | Behavioral: Recommendation of regular exercise<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour blood pressure |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum oxygen uptake |  | 12 weeks | 
| Endothelial function |  | 12 weeks | 
| Echocardiographic left ventricular function |  | 12 weeks | 
| Quality of life |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, endurance training, endothelial function, left ventricular function, Echocardiography, Quality of life, Essential hypertension grade 1 - 2