Physical Exercise in Hypertension, Randomised Clinical Trial

NCT ID: NCT00218972

Last Updated: 2013-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2008-12-31

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.

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Aerobic interval training

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

moderate intensity training

Intervention Type: BEHAVIORAL

Recommendation of regular exercise

No training intervention, general advice as prescribed in guidelines.

Group Type: ACTIVE_COMPARATOR

Recommendation of regular exercise

Intervention Type: BEHAVIORAL

Interventions

Aerobic interval training

Intervention Type: BEHAVIORAL

moderate intensity training

Intervention Type: BEHAVIORAL

Recommendation of regular exercise

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Essential hypertension grade 1 - 2 without medical treatment

Exclusion Criteria

• End organ damage
• Two or more cardiovascular risk factors
• Diabetes

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Asbjorn Stoylen, Dr. Med

Role: STUDY_DIRECTOR

Dept. of Circulation and Medical Imaging, Faculty of Medicine, Norwegian University of Science and Technology

Locations

Norwegian University of Science and Technology

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: RESULT

PMID: 21450580 (View on PubMed)

Other Identifiers

Traininghypertension

Identifier Type: -

Identifier Source: org_study_id

NCT00805363

Identifier Type: -

Identifier Source: nct_alias