AgingNCT01883271
Effect of Aerobic Interval Training on Cardiovascular Function in Aging
A study testing High intensity aerobic interval training and Continuous moderate intensity exercise in people with Aging, run by University of Florida at 1 site in United States.
Trial summary
Study objectives: 1. To compare cardiovascular function in older compared to young healthy adults. 2. To compare the effect of 8 weeks of aerobic interval training vs. continuous moderate exercise on cardiovascular function in healthy older adults. Hypotheses: 1. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- High intensity aerobic interval training and Continuous moderate intensity exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to 21 Feb 2019
- 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 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women 55 to 79 years of age
- Sedentary or minimally physically active for at least the prior 1 year.
- Women will be premenopausal or postmenopausal (either natural or surgical) defined as a cessation of menses for at least 2 years.
- Premenopausal women will be eumenorrheic and will be studied during the early follicular phase (days 1 through 6) of the menstrual cycle.
- Able to give consent.
- Healthy men and women 18 to 35 years of age
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- Sedentary or minimally physically active for at least the prior 1 year.
- Women will be premenopausal, eumenorrheic and will be studied during the early follicular phase (days 1 through 6) of the menstrual cycle.
- Able to give consent.
Who cannot join
- history of diabetes
- history of any relevant cardiovascular diseases (myocardial infarction, angina pectoris, history of coronary artery bypass surgery or angioplasty, congestive heart failure, or arrhythmia)
- hypertension (≥160 mmHg systolic or ≥100 mmHg diastolic)
- history of renal impairment
- history of gout or hyperuricemia
- history of hepatic disease or infection with hepatitis B, C
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- history of seizures, or other relevant on-going or recurrent illness
- recent (within 3 months) or recurrent hospitalizations
- use of tobacco products
- >5 % weight change in the prior 6 months.
- current intake of medications that may affect study results
- participation in regular aerobic exercise training (>30 minutes,
- 3 times/wk in the past year).
- premenopausal women taking oral contraceptives and postmenopausal women taking hormone replacement therapy.
- pregnancy (positive urine pregnancy test) or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Aerobic Interval vs. Continuous Exercise Training on Cardiovascular Function in Aging
Study objectives:
- To compare cardiovascular function in older compared to young healthy adults.
- To compare the effect of 8 weeks of aerobic interval training vs. continuous moderate exercise on cardiovascular function in healthy older adults.
Hypotheses:
- Compared to young adults, older adults will have lower cardiovascular function.
- Compared to continuous moderate intensity exercise training, interval training will be more effective in improving cardiovascular function in older adults.
Read the detailed description
Cardiovascular function will be measured at baseline in older healthy adults and young healthy controls. Older adults will be randomized to the aerobic interval training group, continuous moderate exercise group or non-exercise control group. At the end of the 8-week exercise intervention, baseline measures will be repeated in the older adults.
- Conditions
- Aging
- Being tested
- High intensity aerobic interval training, Continuous moderate intensity exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity aerobic interval trainingOther
Supervised aerobic interval training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 40 minutes and will consist of 10-minute warm up at 70% of maximal heart rate (HRmax), four 4-minute intervals at 90% of HRmax with 3-min active recovery at 70% of HRmax and 5-minute cool down at 70% of HRmax.
Continuous moderate intensity exerciseOther
Supervised exercise training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 47 minutes and will consist of continuous moderate intensity cycling at 70% of HRmax.
| Study group | Role | What they receive |
|---|---|---|
| High intensity aerobic interval training | Experimental | Older adults will complete 8 weeks of high intensity aerobic interval exercise training. Receives: Other: High intensity aerobic interval training |
| Continuous moderate intensity exercise | Experimental | Older adults will complete 8 weeks of continuous moderate intensity exercise training. Receives: Other: Continuous moderate intensity exercise |
| Non-exercise control group | No intervention | Older adults assigned to the non-exercise control group will maintain their normal lifestyle for 8 weeks. |
| Young Healthy controls | No intervention | Young healthy subjects will be assigned to the healthy control group and will undergo baseline measures only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vascular endothelial function
Brachial flow-mediated dilation using ultrasonography
Measured: At baseline and after 8 weeks of exercise training
Secondary outcomes (4)
Change in factors related with endothelial function
Blood and cellular markers of oxidative stress and inflammation
Measured: At baseline and after 8 weeks of exercise training
Change in arterial stiffness
Arterial stiffness and wave reflection will be measured using the SphygmoCor device
Measured: At baseline and after 8 weeks of exercise training
Change in cardiac function
Left ventricular systolic and diastolic function will be measured using echocardiography
Measured: At baseline and after 8 weeks of exercise training
Change in maximal oxygen consumption
Maximal oxygen consumption will be measured using online computer-assisted open-circuit spirometry during incremental treadmill exercise
Measured: At baseline and after 8 weeks of exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startMay 2013
- Primary completion21 Feb 2019
- Study completion21 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Demetra D Christou, Ph.D, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883271
- Sponsor's protocol ID
- IRB201700044
- Other IDs
- 551-2012
- Status last verified
- Feb 2019
- First submitted
- 13 Jun 2013
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Interval vs. Continuous Exercise Training on Cardiovascular Function in Aging
- ClinicalTrials.gov ID
- NCT01883271
- Acronym / sponsor ID
- IRB201700044
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 21 Jun 2013 (estimated)
- 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.
Study objectives:
- To compare cardiovascular function in older compared to young healthy adults.
- To compare the effect of 8 weeks of aerobic interval training vs. continuous moderate exercise on cardiovascular function in healthy older adults.
Hypotheses:
- Compared to young adults, older adults will have lower cardiovascular function.
- Compared to continuous moderate intensity exercise training, interval training will be more effective in improving cardiovascular function in older adults.
Detailed description
Cardiovascular function will be measured at baseline in older healthy adults and young healthy controls. Older adults will be randomized to the aerobic interval training group, continuous moderate exercise group or non-exercise control group. At the end of the 8-week exercise intervention, baseline measures will be repeated in the older adults.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High intensity aerobic interval training | Experimental | Other: High intensity aerobic interval trainingOlder adults will complete 8 weeks of high intensity aerobic interval exercise training. |
| Continuous moderate intensity exercise | Experimental | Other: Continuous moderate intensity exerciseOlder adults will complete 8 weeks of continuous moderate intensity exercise training. |
| Non-exercise control group | No intervention | –Older adults assigned to the non-exercise control group will maintain their normal lifestyle for 8 weeks. |
| Young Healthy controls | No intervention | –Young healthy subjects will be assigned to the healthy control group and will undergo baseline measures only. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy men and women 55 to 79 years of age
- Sedentary or minimally physically active for at least the prior 1 year.
- Women will be premenopausal or postmenopausal (either natural or surgical) defined as a cessation of menses for at least 2 years.
- Premenopausal women will be eumenorrheic and will be studied during the early follicular phase (days 1 through 6) of the menstrual cycle.
- Able to give consent.
Key exclusion criteria (15 listed)
- history of diabetes
- history of any relevant cardiovascular diseases (myocardial infarction, angina pectoris, history of coronary artery bypass surgery or angioplasty, congestive heart failure, or arrhythmia)
- hypertension (≥160 mmHg systolic or ≥100 mmHg diastolic)
- history of renal impairment
- history of gout or hyperuricemia
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 |
|---|---|---|
| High intensity aerobic interval trainingSupervised aerobic interval training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 40 minutes and will consist of 10-minute warm up at 70% of maximal heart rate (HRmax), four 4-minute intervals at 90% of HRmax with 3-min active recovery at 70% of HRmax and 5-minute cool down at 70% of HRmax. | Other | High intensity aerobic interval training |
| Continuous moderate intensity exerciseSupervised exercise training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 47 minutes and will consist of continuous moderate intensity cycling at 70% of HRmax. | Other | Continuous moderate intensity exercise |
Primary outcome
Change in vascular endothelial function
Time frame: At baseline and after 8 weeks of exercise training
Brachial flow-mediated dilation using ultrasonography
4 secondary outcomes
Change in factors related with endothelial function
Time frame: At baseline and after 8 weeks of exercise training
Change in arterial stiffness
Time frame: At baseline and after 8 weeks of exercise training
Change in cardiac function
Time frame: At baseline and after 8 weeks of exercise training
Change in maximal oxygen consumption
Time frame: At baseline and after 8 weeks of exercise training
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 25 Feb 2019.
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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.
Demetra D Christou, Ph.D principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity aerobic interval training and Continuous moderate intensity exercise in people with Aging, run by University of Florida 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 9 inclusion and 15 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 25 Feb 2019. 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 vascular endothelial function (time frame: At baseline and after 8 weeks of exercise training). 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 25 Feb 2019.