Physical Exercise in Hypertension, Randomised Clinical Trial
1 other identifier
interventional
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hypertension
Started Feb 2005
Longer than P75 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 20, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedDecember 6, 2013
December 1, 2013
3.6 years
September 20, 2005
December 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
24 hour blood pressure
12 weeks
Secondary Outcomes (4)
Maximum oxygen uptake
12 weeks
Endothelial function
12 weeks
Echocardiographic left ventricular function
12 weeks
Quality of life
12 weeks
Study Arms (3)
AIT: aerobic interval training
ACTIVE COMPARATORHigh 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.
MIT, moderate intensity training
ACTIVE COMPARATORModerate 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.
Recommendation of regular exercise
ACTIVE COMPARATORNo training intervention, general advice as prescribed in guidelines.
Interventions
Eligibility Criteria
You may qualify if:
- Essential hypertension grade 1 - 2 without medical treatment
You may not qualify if:
- End organ damage
- Two or more cardiovascular risk factors
- Diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
Study Sites (1)
Norwegian University of Science and Technology
Trondheim, N-7489, Norway
Related Publications (1)
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.
PMID: 21450580RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Asbjorn Stoylen, Dr. Med
Dept. of Circulation and Medical Imaging, Faculty of Medicine, Norwegian University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2005
First Posted
September 22, 2005
Study Start
February 1, 2005
Primary Completion
September 1, 2008
Study Completion
December 1, 2008
Last Updated
December 6, 2013
Record last verified: 2013-12