Physical Exercise in Hypertension, Randomised Clinical Trial
| Tracking Information | |||||
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| First Received Date ICMJE | September 20, 2005 | ||||
| Last Updated Date | September 1, 2011 | ||||
| Start Date ICMJE | February 2005 | ||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
24 hour blood pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
24 hour blood pressure | ||||
| Change History | Complete list of historical versions of study NCT00218972 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Physical Exercise in Hypertension, Randomised Clinical Trial | ||||
| Official Title ICMJE | Physical Exercise in Hypertension, Randomised Clinical Trial | ||||
| 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. |
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| 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:
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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Hypertension | ||||
| Intervention ICMJE | Behavioral: Endurance exercise
The intensity description is given under the arms description |
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| Study Arm (s) |
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| 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 Cardiovasc Prev Rehabil. 2011 Mar 4; [Epub ahead of print] | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 88 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00218972 | ||||
| Other Study ID Numbers ICMJE | Traininghypertension | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Norwegian University of Science and Technology | ||||
| Study Sponsor ICMJE | Norwegian University of Science and Technology | ||||
| Collaborators ICMJE | St. Olavs Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | Norwegian University of Science and Technology | ||||
| Verification Date | September 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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