Cardiovascular DiseasesCardioRACENCT03069092
Comparison of the Cardiovascular Benefits of Resistance, Aerobic, and Combined Exercise
A study testing aerobic exercise, resistance exercise and Combined resistance and aerobic exercise in people with Cardiovascular Diseases, run by Iowa State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- aerobic exercise, resistance exercise and Combined resistance and aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- aerobic exercise, resistance exercise, Combined resistance and aerobic exercise
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseBehavioural
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 exerciseBehavioural
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 exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise (AE) | Experimental | 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. Receives: Behavioral: aerobic exercise |
| Resistance exercise (RE) | Experimental | 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. Receives: Behavioral: resistance exercise |
| Combined Resistance and Aerobic Exercise | Experimental | 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. Receives: Behavioral: Combined resistance and aerobic exercise |
| No training control | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in composite cardiovascular disease risk score (z-score)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Jul 2017
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duck-chul Lee, Iowa State University
- Investigators
- Duck-chul Lee, Ph.D., Principal investigator, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069092
- Sponsor's protocol ID
- 1R01HL133069-01
- Acronym
- CardioRACE
- Status last verified
- Aug 2021
- First submitted
- 23 Feb 2017
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Datasets will be available to outside researchers and public health professionals through the web sites of the ClinicalTrials.gov and The Physical Activity Epidemiology Laboratory at Iowa State University. Outside researchers can learn what data are available and request a de-identified dataset (stripped of all personal health identifiers). All outside investigators must pass an NIH-approved equivalent course on the Protection of Human Subjects. All data requests will be discussed with the research team and approval will be obtained from the institutional review board overseeing the proposal of the data analysis project. Findings from the proposed study will also be disseminated at national and international meetings and publish the findings in peer-reviewed journals. The investigators seek to maximize the knowledge discovered from this study by sharing data to expedite the translation of research into practice to improve cardiovascular health.
Publications
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.
PubMed 31520895
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Cardiovascular Benefits of Resistance, Aerobic, and Combined Exercise
- ClinicalTrials.gov ID
- NCT03069092
- Acronym / sponsor ID
- CardioRACE / 1R01HL133069-01
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise (AE) | Experimental | Behavioral: aerobic exerciseAE 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) | Experimental | Behavioral: resistance exerciseRE 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 | Experimental | Behavioral: Combined resistance and aerobic exerciseParticipants 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 | No intervention | –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). |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exerciseAE 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. | Behavioural | Aerobic exercise (AE) |
| resistance exerciseRE 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 | Behavioural | Resistance exercise (RE) |
| Combined resistance and aerobic exerciseParticipants 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. | Behavioural | Combined Resistance and Aerobic Exercise |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Derived from this study: PubMed 31520895Brellenthin 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.
- Information regarding Dr. Lee's laboratory at Iowa State University.Link provided by the sponsor.
- Study website, including contact information for recruitmentLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Datasets will be available to outside researchers and public health professionals through the web sites of the ClinicalTrials.gov and The Physical Activity Epidemiology Laboratory at Iowa State University. Outside researchers can learn what data are available and request a de-identified dataset (stripped of all personal health identifiers). All outside investigators must pass an NIH-approved equivalent course on the Protection of Human Subjects. All data requests will be discussed with the research team and approval will be obtained from the institutional review board overseeing the proposal of the data analysis project. Findings from the proposed study will also be disseminated at national and international meetings and publish the findings in peer-reviewed journals. The investigators seek to maximize the knowledge discovered from this study by sharing data to expedite the translation of research into practice to improve cardiovascular health.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duck-chul Lee, Ph.D. principal investigator
Iowa State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise, resistance exercise and Combined resistance and aerobic exercise in people with Cardiovascular Diseases, run by Iowa State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in composite cardiovascular disease risk score (z-score) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03069092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.