Treatment of Hypertension With Two Exercise Intensities

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00004561
First received: February 9, 2000
Last updated: May 12, 2016
Last verified: August 2004
  Purpose
To determine whether exercise training could significantly replace medication as a treatment for mild essential hypertension.

Condition Intervention Phase
Hypertension
Behavioral: exercise
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: June 1997
Study Completion Date: May 2003
Detailed Description:

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 After 12 months participation, medication was withdrawn under careful supervision from all subjects still taking it.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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00004561     History of Changes
Other Study ID Numbers: 129  R01HL056907 
Study First Received: February 9, 2000
Last Updated: May 12, 2016
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2016