- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03734146
Independent and Combined Effects of Aerobic and Resistance Training on Blood Pressure (ART-B)
November 5, 2018 updated by: Iowa State University
We compared the effects of 8 weeks of aerobic exercise only, resistance exercise only, or a combination of both on blood pressure in overweight or obese middle-aged adults with elevated blood pressure.
Participants engaged in supervised exercise sessions 3 times per week for 60 minutes each session.
Outcomes were assessed at baseline and after the 8-week intervention.
Extra-intervention physical activity and diet were also assessed.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Systolic/diastolic blood pressure of 120-159/80-99 mm Hg
- Non-smoking
- Overweight or obese, with a body mass index of 25-40 kg/m2
- Inactive--not meeting the aerobic or resistance physical activity guidelines, which means engaging in less than 150 minutes/wk of moderate intensity aerobic exercise and less than 2 days per week of resistance training over the past 3 months.
Exclusion Criteria:
- Unstable coronary heart disease or decompensated heart failure
- Severe pulmonary hypertension or aortic stenosis
- Acute myocarditis, endocarditis, pericarditis, or aortic dissection
- Other medical condition that is life-threatening or that can interfere or be aggravated by the exercise training such as cancer, uncontrolled diabetes, severe pain or mobility limitations.
- Premenopausal women or postmenopausal women taking hormonal replacement therapy
- Pregnant women or anticipated pregnancy via IVF or other medical procedures during the course of the intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aerobic exercise (AE)
Engage in supervised aerobic exercise for 60 minutes on 3 days per week for 8 weeks.
Exercise is performed on a recumbent bike or treadmill at 50-80% of their heart rate reserve.
|
180 minutes of moderate-vigorous intensity aerobic exercise per week
|
|
Experimental: Resistance exercise (RE)
Engage in supervised resistance exercise for 60 minutes on 3 days per week for 8 weeks.
Exercise consists of 3 sets of 8-12 repetitions of 12 exercises for the major muscle groups.
|
180 minutes of resistance exercise per week
|
|
Experimental: Combined Resistance and Aerobic Exercise
Engage in supervised aerobic resistance exercise for 60 minutes on 3 days per week for 8 weeks.
Exercise consists of 30 min aerobic exercise at 50-80% heart rate reserve and 30 min of resistance exercise comprising 2 sets of 8-12 repetitions of 9 exercises for the major muscle groups.
|
180 minutes of exercise per week with 90 minutes per week coming from moderate-vigorous intensity aerobic exercise and 90 minutes per week coming from resistance exercise
|
|
No Intervention: No training control
No exercise training.
Participants will refrain from any moderate-vigorous exercise or resistance training for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in resting blood pressure
Time Frame: Immediately before and after the 8 week intervention
|
resting systolic and diastolic blood pressure
|
Immediately before and after the 8 week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Duck-chul Lee, PhD, Iowa State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2014
Primary Completion (Actual)
December 19, 2014
Study Completion (Actual)
December 19, 2014
Study Registration Dates
First Submitted
October 31, 2018
First Submitted That Met QC Criteria
November 5, 2018
First Posted (Actual)
November 7, 2018
Study Record Updates
Last Update Posted (Actual)
November 7, 2018
Last Update Submitted That Met QC Criteria
November 5, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 14-330
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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