NCT00218972

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 6, 2013

Status Verified

December 1, 2013

Enrollment Period

3.6 years

First QC Date

September 20, 2005

Last Update Submit

December 5, 2013

Conditions

Keywords

Hypertensionendurance trainingendothelial functionleft ventricular functionEchocardiographyQuality of lifeEssential hypertension grade 1 - 2

Outcome Measures

Primary Outcomes (1)

  • 24 hour blood pressure

    12 weeks

Secondary Outcomes (4)

  • Maximum oxygen uptake

    12 weeks

  • Endothelial function

    12 weeks

  • Echocardiographic left ventricular function

    12 weeks

  • Quality of life

    12 weeks

Study Arms (3)

AIT: aerobic interval training

ACTIVE COMPARATOR

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: Aerobic interval training

MIT, moderate intensity training

ACTIVE COMPARATOR

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: moderate intensity training

Recommendation of regular exercise

ACTIVE COMPARATOR

No training intervention, general advice as prescribed in guidelines.

Behavioral: Recommendation of regular exercise

Interventions

AIT: aerobic interval training
MIT, moderate intensity training
Recommendation of regular exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Essential hypertension grade 1 - 2 without medical treatment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, N-7489, Norway

Location

Related 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. doi: 10.1177/1741826711400512. Epub 2011 Mar 4.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Asbjorn Stoylen, Dr. Med

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

February 1, 2005

Primary Completion

September 1, 2008

Study Completion

December 1, 2008

Last Updated

December 6, 2013

Record last verified: 2013-12

Locations