Effect of Aerobic Exercise on Blood Pressure Changes

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00358137
First received: July 28, 2006
Last updated: December 12, 2007
Last verified: December 2007
  Purpose

This study will evaluate the effect of an aerobic training program versus a strength training program on the autonomic nervous system at rest and in response to challenge.


Condition Intervention
Hypertension
Cardiovascular Diseases
Behavioral: Aerobic Conditioning Program
Behavioral: Strength Training Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Psychophysiologic Stress, Exercise, & Autonomic Control

Resource links provided by NLM:


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

Primary Outcome Measures:
  • RR inverval (RRV) and blood pressure variability at rest and in response to challenge (measured prior to exercise training and again after training and after sedentary deconditioning).

Secondary Outcome Measures:
  • Secondary outcome measures include ambulatory blood pressure.

Enrollment: 149
Study Start Date: July 1997
Study Completion Date: January 2003
Detailed Description:

The purpose of this study is to compare the effectiveness of an aerobic exercise program versus a strength training program in altering RR interval and blood pressure variability as indices of autonomic nervous system regulation of the cardiovascular system. Subjects will be tested at rest and in response to challenge.

This study will enroll healthy, young (age 18-45) sedentary individuals at Columbia University Medical Center and St. John's University. At an initial screening visit, potential participants will be screened for exercise activity and will also undergo a test of aerobic capacity. Subjects will be eligible if they are not exercising regularly and do not exceed American Heart Association standards for average fitness (VO2max ≤ 43 and 37 ml/kg/min for men and women respectively). Exclusion criteria include current symptoms of affective disorder, psychosis, or substance abuse, current usage of psychotropic medication, and any medical condition that affected the autonomic nervous system or cardiovascular system.

Eligible participants will then be randomly assigned to 12 weeks of either an aerobic conditioning program or a strength training program. At study entry, heart rate, respiratory rate, and blood pressure will be measured; an ECG will be used to measure heart activity. Questionnaires will be completed to assess anger, tension, depression, and fatigue. Participants in the aerobic conditioning program will attend four 1-hour exercise sessions per week, which will focus on increasing cardiovascular fitness through running and other forms of aerobic exercise. The strength training program will also include four sessions per week, with the focus on increasing muscle endurance and strength. At the end of the 12-week programs, participants will begin a 4-week period of deconditioning, during which they will discontinue all exercise. Evaluations will be repeated at the end of the 12-week programs, and at the end of the 4-week deconditioning period.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Average cardiorespiratory fitness level, as defined by the American Heart Association (VO2 max [maximum oxygen consumption] less than 43 ml/kg/min for men and less than 37 ml/kg/min for women)
  • English speaking
  • Ambulatory
  • Sedentary

Exclusion Criteria:

  • Use of psychotropic medications
  • Past or current psychiatric disorder
  • Heart disease
  • High blood pressure
  • Diabetes mellitus
  • Neurologic disease
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358137

Sponsors and Collaborators
Investigators
Principal Investigator: Richard P. Sloan, PhD Columbia University
  More Information

No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard P. Sloan, Columbia University
ClinicalTrials.gov Identifier: NCT00358137     History of Changes
Other Study ID Numbers: 404, R01 HL061287-04
Study First Received: July 28, 2006
Last Updated: December 12, 2007
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Blood Pressure, High

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014