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Physical Exercise in Hypertension, Randomised Clinical Trial

NCT ID: NCT00218972

Last Updated: 2013-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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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

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Hypertension

Keywords

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Hypertension endurance training endothelial function left ventricular function Echocardiography Quality of life Essential hypertension grade 1 - 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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Aerobic interval training

Intervention Type BEHAVIORAL

moderate intensity training

Intervention Type BEHAVIORAL

Recommendation of regular exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Asbjorn Stoylen, Dr. Med

Role: STUDY_DIRECTOR

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

Locations

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Norwegian University of Science and Technology

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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

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Traininghypertension

Identifier Type: -

Identifier Source: org_study_id

NCT00805363

Identifier Type: -

Identifier Source: nct_alias