Physical Exercise in Hypertension, Randomised Clinical Trial
Behavioral: Aerobic interval training
Behavioral: moderate intensity training
Behavioral: Recommendation of regular exercise
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Physical Exercise in Hypertension, Randomised Clinical Trial|
- 24 hour blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Maximum oxygen uptake [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Endothelial function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Echocardiographic left ventricular function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|