Effect of Aerobic Interval Training on Cardiovascular Function in Aging

• ClinicalTrials.gov Identifier: NCT01883271
• Recruitment Status: Completed
• First Posted: June 21, 2013
• Last Update Posted: February 25, 2019
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

Tracking Information

• First Submitted Date: June 13, 2013
• First Posted Date: June 21, 2013
• Last Update Posted Date: February 25, 2019
• Study Start Date: May 2013
• Actual Primary Completion Date: February 21, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 18, 2013)

Change in vascular endothelial function [ Time Frame: At baseline and after 8 weeks of exercise training ]

Brachial flow-mediated dilation using ultrasonography

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 18, 2013)

• 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
• 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
• Change in cardiac function [ Time Frame: At baseline and after 8 weeks of exercise training ]
  Left ventricular systolic and diastolic function will be measured using echocardiography
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Aerobic Interval Training on Cardiovascular Function in Aging
• Official Title: Effect of Aerobic Interval vs. Continuous Exercise Training on Cardiovascular Function in Aging

Brief 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. Compared to young adults, older adults will have lower cardiovascular function.
2. 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Other
• Condition: Aging

Intervention

• Other: High intensity aerobic interval 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.
• Other: Continuous moderate intensity exercise
  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 Arms

• Experimental: High intensity aerobic interval training
  Older adults will complete 8 weeks of high intensity aerobic interval exercise training.
  Intervention: Other: High intensity aerobic interval training
• Experimental: Continuous moderate intensity exercise
  Older adults will complete 8 weeks of continuous moderate intensity exercise training.
  Intervention: Other: Continuous moderate intensity exercise
• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 22, 2019): 60
• Original Estimated Enrollment (submitted: June 18, 2013): 125
• Actual Study Completion Date: February 21, 2019
• Actual Primary Completion Date: February 21, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 79 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01883271
• Other Study ID Numbers: IRB201700044; 551-2012 ( Other Identifier: University of Florida )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Florida
• Study Sponsor: University of Florida
• Collaborators: Not Provided

Investigators

• Principal Investigator: Demetra D Christou, Ph.D; University of Florida

• PRS Account: University of Florida
• Verification Date: February 2019