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Effect of Aerobic Interval Training on Cardiovascular Function in Aging

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

Tracking Information
First Submitted Date  ICMJE June 13, 2013
First Posted Date  ICMJE June 21, 2013
Last Update Posted Date February 25, 2019
Study Start Date  ICMJE May 2013
Actual Primary Completion Date February 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Aerobic Interval Training on Cardiovascular Function in Aging
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Aging
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2019)
60
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2013)
125
Actual Study Completion Date  ICMJE February 21, 2019
Actual Primary Completion Date February 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01883271
Other Study ID Numbers  ICMJE IRB201700044
551-2012 ( Other Identifier: University of Florida )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Demetra D Christou, Ph.D University of Florida
PRS Account University of Florida
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP