Physical Exercise in Hypertension, Randomised Clinical Trial
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|ClinicalTrials.gov Identifier: NCT00218972|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 6, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Behavioral: Aerobic interval training Behavioral: moderate intensity training Behavioral: Recommendation of regular exercise||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Physical Exercise in Hypertension, Randomised Clinical Trial|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||December 2008|
Active Comparator: AIT: aerobic interval training
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|
Active Comparator: MIT, moderate intensity training
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|
Active Comparator: Recommendation of regular exercise
No training intervention, general advice as prescribed in guidelines.
|Behavioral: Recommendation of regular exercise|
- 24 hour blood pressure [ Time Frame: 12 weeks ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00218972
|Norwegian University of Science and Technology|
|Trondheim, Norway, N-7489|
|Study Director:||Asbjorn Stoylen, Dr. Med||Dept. of Circulation and Medical Imaging, Faculty of Medicine, Norwegian University of Science and Technology|