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

July 28, 2006
December 12, 2007
July 1997
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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).
Blood pressure variability responses to challenge (measured at Weeks 16 and 20)
Complete list of historical versions of study NCT00358137 on ClinicalTrials.gov Archive Site
Secondary outcome measures include ambulatory blood pressure.
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Effect of Aerobic Exercise on Blood Pressure Changes
Psychophysiologic Stress, Exercise, & Autonomic Control

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.

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.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Hypertension
  • Cardiovascular Diseases
  • Behavioral: Aerobic Conditioning Program
  • Behavioral: Strength Training Program
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Alex C, Lindgren M, Shapiro PA, McKinley PS, Brondolo EN, Myers MM, Zhao Y, Sloan RP. Aerobic exercise and strength training effects on cardiovascular sympathetic function in healthy adults: a randomized controlled trial. Psychosom Med. 2013 May;75(4):375-81. doi: 10.1097/PSY.0b013e3182906810. Epub 2013 Apr 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
149
January 2003
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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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00358137
404, R01 HL061287-04
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Richard P. Sloan, Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Richard P. Sloan, PhD Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP