- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01883271
Effect of Aerobic Interval Training on Cardiovascular Function in Aging
February 22, 2019 updated by: University of Florida
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32611
- University of Florida
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-
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
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria for older adults:
- 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.
Inclusion Criteria for young adults:
- Healthy men and women 18 to 35 years of age
- 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.
Exclusion Criteria:
- 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
- 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
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High intensity aerobic interval training
Older adults will complete 8 weeks of high intensity aerobic interval exercise training.
|
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.
|
|
Experimental: Continuous moderate intensity exercise
Older adults will complete 8 weeks of continuous moderate intensity exercise training.
|
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.
|
|
No Intervention: Non-exercise control group
Older adults assigned to the non-exercise control group will maintain their normal lifestyle for 8 weeks.
|
|
|
No Intervention: Young Healthy controls
Young healthy subjects will be assigned to the healthy control group and will undergo baseline measures only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in vascular endothelial function
Time Frame: At baseline and after 8 weeks of exercise training
|
Brachial flow-mediated dilation using ultrasonography
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At baseline and after 8 weeks of exercise training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in factors related with endothelial function
Time Frame: At baseline and after 8 weeks of exercise training
|
Blood and cellular markers of oxidative stress and inflammation
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At baseline and after 8 weeks of exercise training
|
|
Change in arterial stiffness
Time Frame: At baseline and after 8 weeks of exercise training
|
Arterial stiffness and wave reflection will be measured using the SphygmoCor device
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At baseline and after 8 weeks of exercise training
|
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Change in cardiac function
Time Frame: At baseline and after 8 weeks of exercise training
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Left ventricular systolic and diastolic function will be measured using echocardiography
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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
|
Maximal oxygen consumption will be measured using online computer-assisted open-circuit spirometry during incremental treadmill exercise
|
At baseline and after 8 weeks of exercise training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Demetra D Christou, Ph.D, University of Florida
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
May 1, 2013
Primary Completion (Actual)
February 21, 2019
Study Completion (Actual)
February 21, 2019
Study Registration Dates
First Submitted
June 13, 2013
First Submitted That Met QC Criteria
June 18, 2013
First Posted (Estimate)
June 21, 2013
Study Record Updates
Last Update Posted (Actual)
February 25, 2019
Last Update Submitted That Met QC Criteria
February 22, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- IRB201700044
- 551-2012 (Other Identifier: University of Florida)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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