Effect of Aerobic Exercise on Blood Pressure Changes

Hypertension Clinical Trial

Official title:

Psychophysiologic Stress, Exercise, & Autonomic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358137
• Other study ID #: 404
• Secondary ID: R01HL061287-04
• Status: Completed
• Phase: N/A
• First received: July 28, 2006
• Last updated: February 17, 2016
• Start date: July 1997
• Est. completion date: January 2003

Study information

• Verified date: December 2007
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: January 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension

Intervention

Behavioral:
• Aerobic Conditioning Program

• Strength Training Program

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary outcome measures include ambulatory blood pressure.