Clinical trial NCT00358137: Effect of Aerobic Exercise on Blood Pressure Changes
Official title: Psychophysiologic Stress, Exercise, & Autonomic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cardiovascular Diseases
Keywords: Blood Pressure, High
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2006-07-31
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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 outcomes:
measure: Secondary outcome measures include ambulatory blood pressure.
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: Richard P. Sloan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.