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

NCT ID: NCT03069092

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 406 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2021-04-30

Brief Summary

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.

Detailed Description

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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Aerobic exercise (AE)

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.

Group Type: EXPERIMENTAL

aerobic exercise

Intervention Type: 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 (RE)

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.

Group Type: EXPERIMENTAL

resistance exercise

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Combined resistance and aerobic exercise

Intervention Type: 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.

No training control

Participants in this group will be asked to maintain their current level of activity during the 1 year study period. After 1 year, they will be offered the training program of their choice (AE, RE, or combined).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

aerobic exercise

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.

Intervention Type: BEHAVIORAL

resistance exercise

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

Intervention Type: BEHAVIORAL

Combined resistance and aerobic exercise

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Iowa State University

OTHER

Sponsor Role: lead

Responsible Party

Duck-chul Lee

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Duck-chul Lee, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Iowa State University

Locations

Iowa State University

Ames, Iowa, United States

Countries

United States

References

Brellenthin AG, Lanningham-Foster LM, Kohut ML, Li Y, Church TS, Blair SN, Lee DC. Comparison of the Cardiovascular Benefits of Resistance, Aerobic, and Combined Exercise (CardioRACE): Rationale, design, and methods. Am Heart J. 2019 Nov;217:101-111. doi: 10.1016/j.ahj.2019.08.008. Epub 2019 Aug 15.

Reference Type: DERIVED

PMID: 31520895 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

http://www.kin.hs.iastate.edu/research/physical-activity-epidemiology/

Information regarding Dr. Lee's laboratory at Iowa State University.

https://research.hs.iastate.edu/cardiorace

Study website, including contact information for recruitment

Other Identifiers

1R01HL133069-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link