Cardiovascular Risk FactorART-BNCT03734146
Independent and Combined Effects of Aerobic and Resistance Training on Blood Pressure
A study testing Aerobic Exercise, Resistance Exercise and Combined aerobic and resistance exercise in people with Cardiovascular Risk Factor, run by Iowa State University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Aerobic Exercise, Resistance Exercise and Combined aerobic and resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2014to 19 Dec 2014
- 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 45 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Aerobic Exercise, Resistance Exercise, Combined aerobic and resistance exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
180 minutes of moderate-vigorous intensity aerobic exercise per week
Resistance ExerciseBehavioural
180 minutes of resistance exercise per week
Combined aerobic and resistance exerciseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise (AE) | Experimental | 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. Receives: Behavioral: Aerobic Exercise |
| Resistance exercise (RE) | Experimental | 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. Receives: Behavioral: Resistance Exercise |
| Combined Resistance and Aerobic Exercise | Experimental | 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. Receives: Behavioral: Combined aerobic and resistance exercise |
| No training control | No intervention | No exercise training. Participants will refrain from any moderate-vigorous exercise or resistance training for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in resting blood pressure
resting systolic and diastolic blood pressure
Measured: Immediately before and after the 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start15 Jul 2014
- Primary completion19 Dec 2014
- Study completion19 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duck-chul Lee, PhD, Principal investigator, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734146
- Sponsor's protocol ID
- 14-330
- Acronym
- ART-B
- Status last verified
- Oct 2018
- First submitted
- 31 Oct 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independent and Combined Effects of Aerobic and Resistance Training on Blood Pressure
- ClinicalTrials.gov ID
- NCT03734146
- Acronym / sponsor ID
- ART-B / 14-330
- Conditions
- Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- 15 Jul 2014 (actual)
- Primary completion
- 19 Dec 2014 (actual)
- Study completion
- 19 Dec 2014 (actual)
- First posted
- 7 Nov 2018 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise (AE) | Experimental | Behavioral: Aerobic ExerciseEngage 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. |
| Resistance exercise (RE) | Experimental | Behavioral: Resistance ExerciseEngage 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. |
| Combined Resistance and Aerobic Exercise | Experimental | Behavioral: Combined aerobic and resistance exerciseEngage 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. |
| No training control | No intervention | –No exercise training. Participants will refrain from any moderate-vigorous exercise or resistance training for 8 weeks. |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 Exercise180 minutes of moderate-vigorous intensity aerobic exercise per week | Behavioural | Aerobic exercise (AE) |
| Resistance Exercise180 minutes of resistance exercise per week | Behavioural | Resistance exercise (RE) |
| Combined aerobic and resistance exercise180 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 | Behavioural | Combined Resistance and Aerobic Exercise |
Primary outcome
Change in resting blood pressure
Time frame: Immediately before and after the 8 week intervention
resting systolic and diastolic blood pressure
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 7 Nov 2018.
- Individual participant dataSharing planned: No
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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, PhD principal investigator
Iowa State University
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise, Resistance Exercise and Combined aerobic and resistance exercise in people with Cardiovascular Risk Factor, run by Iowa State University.
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 4 inclusion and 6 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 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 resting blood pressure (time frame: Immediately before and after the 8 week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2018.