Treatment of Hypertension With Two Exercise Intensities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004561
Recruitment Status : Completed
First Posted : February 10, 2000
Last Update Posted : May 13, 2016
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
To determine whether exercise training could significantly replace medication as a treatment for mild essential hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: exercise Phase 3

Detailed Description:


Arterial hypertension affects over 50 million Americans. While drug treatment is effective, exercise would be safer, might be cheaper, and would bring added health benefits if it could replace drugs in controlling hypertension.


Randomized, controlled trial. Known hypertensives (n=162) whose diastolic blood pressures rose to between 90 and 104 within four months of discontinuing medication under careful observation had their pressures controlled with enalapril. Oxygen consumption (V02) peak was measured during cycle ergometry. Eligible subjects were randomly assigned to 18 months participation in one of three groups: 1) high intensity endurance training (35 minutes three times/week at heart rate at 70-85 percent of V02 peak), 2) moderate intensity endurance training (35 minutes three times/week at heart rate of 50-70 of V02 peak), and 3) contact control. Enalapril was forward or back titrated or discontinued to maintain a normal blood pressure. After 12 months participation, medication was withdrawn under careful supervision from all subjects still taking it. The trial tested the hypotheses that: 1) a greater number of subjects undergoing either or both of the two 18 month exercise training programs would be able to stop anti-hypertensive medication than non-exercising controls, 2) moderate and high intensity endurance training were equally effective in replacing drugs in the treatment of mild essential hypertension, and 3) subjects that were successful at withdrawing anti-hypertensive medication would have: greater improvements in V02 peak, better initial psychological status or greater improvements in psychological status, and greater compliance with the exercise training program.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : June 1997
Actual Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
No eligibility criteria Identifier: NCT00004561     History of Changes
Other Study ID Numbers: 129
R01HL056907 ( U.S. NIH Grant/Contract )
First Posted: February 10, 2000    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: August 2004

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases