Physical Exercise in Hypertension, Randomised Clinical Trial

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00218972
First received: September 20, 2005
Last updated: December 5, 2013
Last verified: December 2013

September 20, 2005
December 5, 2013
February 2005
September 2008   (final data collection date for primary outcome measure)
24 hour blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
24 hour blood pressure
Complete list of historical versions of study NCT00218972 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Maximum oxygen uptake
  • Endothelial function
  • Echocardiographich left vent4ricular function
  • Quality of life
Not Provided
Not Provided
 
Physical Exercise in Hypertension, Randomised Clinical Trial
Physical Exercise in Hypertension, Randomised Clinical Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • Behavioral: Aerobic interval training
  • Behavioral: moderate intensity training
  • Behavioral: Recommendation of regular exercise
  • 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.
    Intervention: 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.
    Intervention: Behavioral: moderate intensity training
  • Active Comparator: Recommendation of regular exercise
    No training intervention, general advice as prescribed in guidelines.
    Intervention: Behavioral: Recommendation of regular exercise
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
December 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Essential hypertension grade 1 - 2 without medical treatment

Exclusion Criteria:

  • End organ damage
  • Two or more cardiovascular risk factors
  • Diabetes
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00218972
Traininghypertension
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
St. Olavs Hospital
Study Director: Asbjorn Stoylen, Dr. Med Dept. of Circulation and Medical Imaging, Faculty of Medicine, Norwegian University of Science and Technology
Norwegian University of Science and Technology
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP