Effect of Aerobic Exercise on Blood Pressure Changes

• ClinicalTrials.gov Identifier: NCT00358137
• Recruitment Status: Completed
• First Posted: July 31, 2006
• Last Update Posted: February 18, 2016
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by: National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information

• First Submitted Date: July 28, 2006
• First Posted Date: July 31, 2006
• Last Update Posted Date: February 18, 2016
• Study Start Date: July 1997
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: June 20, 2007): 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).
• Original Primary Outcome Measures (submitted: July 28, 2006): Blood pressure variability responses to challenge (measured at Weeks 16 and 20)
• Current Secondary Outcome Measures (submitted: June 20, 2007): Secondary outcome measures include ambulatory blood pressure.
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Aerobic Exercise on Blood Pressure Changes
• Official Title: Psychophysiologic Stress, Exercise, & Autonomic Control
• Brief 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.

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment

Condition

• Hypertension
• Cardiovascular Diseases

Intervention

• Behavioral: Aerobic Conditioning Program
• Behavioral: Strength Training Program

• Study Arms: Not Provided
• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 20, 2007): 149
• Original Enrollment (submitted: July 28, 2006): 126
• Actual Study Completion Date: January 2003
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00358137
• Other Study ID Numbers: 404; R01HL061287-04 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Richard P. Sloan, Columbia University
• Study Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Collaborators: Not Provided

Investigators

• Principal Investigator: Richard P. Sloan, PhD; Columbia University

• PRS Account: National Heart, Lung, and Blood Institute (NHLBI)
• Verification Date: December 2007