Completed

Treatment of Hypertension With Two Exercise Intensities

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What is being tested

exercise

Behavioral
Who is being recruted

Cardiovascular Diseases

+ Vascular Diseases

+ Hypertension

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 1997
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: May 13, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 1997

Actual date on which the first participant was enrolled.

BACKGROUND: 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. DESIGN NARRATIVE: 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 After 12 months participation, medication was withdrawn under careful supervision from all subjects still taking it.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.

NCT00004561
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: May 13, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesVascular DiseasesHypertension

Criteria

No eligibility criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers