Clinical trial NCT03069092: Comparison of the Cardiovascular Benefits of Resistance, Aerobic, and Combined Exercise
Official title: Comparison of the Cardiovascular Benefits of Resistance, Aerobic, and Combined Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 406
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in composite cardiovascular disease risk score (z-score)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ames
country: United States
facility: Iowa State University
state: Iowa
Study officials:
affiliation: Iowa State University
name: Duck-chul Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.