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Completed

NCT Number: NCT03069092

Comparison of the Cardiovascular Benefits of Resistance, Aerobic, and Combined Exercise

As the leading cause of death, cardiovascular disease (CVD) accounts for about one-third of U.S. mortality. Physical inactivity, one of the main CVD risk factors, causes 6% of coronary heart disease worldwide. The American Heart Association has identified cardiovascular health behaviors including smoking, obesity, diet, and aerobic exercise; however, resistance exercise was not included due to the limited evidence of its efficacy. Comparatively, the cardiovascular benefits of aerobic training have been well-documented whereas the independent and additive benefits of resistance training on cardiovascular health have not been established. Thus, this project is aimed to answer one of the most common questions about exercise and health:"What type or combination of exercise is most effective for CVD prevention?" This project will significantly contribute to developing more effective CVD prevention approaches, advancing more comprehensive physical activity guidelines, and providing important insights and novel opportunities for the future science of physical activity and health.

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Key information

Conditions

Cardiovascular Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Iowa State University

Ames, Iowa, 50011, United States

About this study

Participants will be randomly assigned to aerobic exercise, resistance exercise, combined aerobic and resistance exercise, or a no exercise control group for 1 year. Participants in all four groups will receive healthy diet and lifestyle education sessions and will track their daily steps, body weights, and food intake throughout the 1-year intervention. They will also complete baseline, 6-month, and 12-month physical examinations, which will include assessments of blood pressure, blood lipids, body composition, and aerobic and muscular fitness.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-smoker
  • Systolic/diastolic blood pressure of 120-139/80-89 mmHg (without taking any anti-hypertensive medication)
  • Overweight or obese: body mass index of 25-40 kg/m2; Asian 23-40 kg/m2
  • Inactive: less than 150 min/week of exercise over the past 3 months
  • Capable of performing the required exercise training

Exclusion criteria

  • Unstable coronary heart disease or heart failure
  • Uncontrolled arrhythmias or severe aortic stenosis
  • Acute myocarditis, endocarditis, or pericarditis
  • Cancer, requiring treatment in the past 5 years
  • Autoimmune diseases, affecting the immune system
  • Plans to be away/travel for greater than 4 weeks in the next year
  • Pregnancy/anticipated pregnancy during the study
  • Other medical condition that is life-threatening or can interfere with or be aggravated by the exercise training

Treatment and study plan

Aerobic Exercise

Behavioral

AE training will consist of 60 min of treadmill, elliptical, or bike exercise at a moderate to vigorous intensity (50-80% of heart rate reserve). Intensity of the exercise sessions will be built up gradually. Sessions will occur 3 times per week for the duration of the 1 year trial.

Resistance exercise

Behavioral

RE will consist of 3 sets of 8-15 repetitions at 50-80% of 1 rep-max of each exercise for 12 exercises (chest press, shoulder press, pull-down, back extension, abdominal crunch, torso rotation, biceps curl, triceps extension, leg press, leg extension, leg curl, and calf raise). Weight loads will be increased gradually. With one minute of rest between sets, this plan is estimated to take approximately 60 minutes per session. Sessions will occur 3 times per week for the duration of the 1 year trial

Combined resistance and aerobic exercise

Behavioral

Participants will perform exactly the same AE and RE exercises as listed previously; however, the time of AE and RE will each be reduced to 30 min (for 60 min/session total). For the RE aspect, participants will perform 2 sets of 8-15 repetitions of 9 exercises (excluding biceps curl, triceps extension, and calf raise, as these are minor muscle groups). Exercise intensity and resistance will be increased gradually. Combined AE and RE sessions will take place 3 times per week for the duration of the trial.

Primary outcomes

  1. Change in composite cardiovascular disease risk score (z-score)

    Time frame: 12 months

    The primary outcome is the change from baseline in the composite cardiovascular disease risk score (z-score) calculated using resting blood pressure, low-density lipoprotein cholesterol, fasting glucose, and percent body fat. Each risk factor will be individually standardized and expressed as sex-specific z-score by using the formula = (value - mean)/standard deviation for each participant.

Sponsors and collaborators

Lead sponsor

Iowa State University

Other

Registry information

Acronym: CardioRACE

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2017
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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