Physical Exercise in Hypertension, Randomised Clinical Trial

Hypertension Clinical Trial

Official title:

Physical Exercise in Hypertension, Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218972
• Other study ID #: Traininghypertension
• Status: Completed
• Phase: N/A
• First received: September 20, 2005
• Last updated: December 5, 2013
• Start date: February 2005
• Est. completion date: December 2008

Study information

• Verified date: December 2013
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00805363

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Essential hypertension grade 1 - 2 without medical treatment

Exclusion Criteria:

• End organ damage

• Two or more cardiovascular risk factors

• Diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Aerobic interval training

• moderate intensity training

• Recommendation of regular exercise

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour blood pressure		12 weeks	No
Secondary	Maximum oxygen uptake		12 weeks	No
Secondary	Endothelial function		12 weeks	No
Secondary	Echocardiographic left ventricular function		12 weeks	No
Secondary	Quality of life		12 weeks	No