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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: September 1, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention
Hypertension
 Behavioral: Endurance exercise

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • 24 hour blood pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum oxygen uptake [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Endothelial function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Echocardiographic left ventricular function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: February 2005
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Endurance exercise
The intensity description is given under the arms description
Active Comparator: MIT, moderate intenisity 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: Endurance exercise
The intensity description is given under the arms description
No Intervention: Recommendation of regular exercise
No training intervention, general advice as prescribed in guidelines.
 Behavioral: Endurance exercise
The intensity description is given under the arms description

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:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Essential hypertension grade 1 - 2 without medical treatment

Exclusion Criteria:

  • End organ damage
  • Two or more cardiovascular risk factors
  • Diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218972

Locations
Norway
Norwegian University of Science and Technology
Trondheim, Norway, N-7489
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Study Director: Asbjorn Stoylen, Dr. Med Dept. of Circulation and Medical Imaging, Faculty of Medicine, Norwegian University of Science and Technology
  More Information

Publications:

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00218972     History of Changes
Obsolete Identifiers: NCT00805363
Other Study ID Numbers: Traininghypertension
Study First Received: September 20, 2005
Last Updated: September 1, 2011
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Hypertension
endurance training
endothelial function
left ventricular function
 Echocardiography
Quality of life
Essential hypertension grade 1 - 2

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013