Effect of Aerobic Interval Training on Cardiovascular Function in Aging

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01883271
First received: June 13, 2013
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.

Condition Intervention
Aging
Other: High intensity aerobic interval training
Other: Continuous moderate intensity exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Effect of Aerobic Interval vs. Continuous Exercise Training on Cardiovascular Function in Aging

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Change in vascular endothelial function [ Time Frame: At baseline and after 8 weeks of exercise training ] [ Designated as safety issue: No ]
    Brachial flow-mediated dilation using ultrasonography


Secondary Outcome Measures:
  • Change in factors related with endothelial function [ Time Frame: At baseline and after 8 weeks of exercise training ] [ Designated as safety issue: No ]
    Blood and cellular markers of oxidative stress and inflammation

  • Change in arterial stiffness [ Time Frame: At baseline and after 8 weeks of exercise training ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Maximal oxygen consumption will be measured using online computer-assisted open-circuit spirometry during incremental treadmill exercise


Estimated Enrollment: 125
Study Start Date: May 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High intensity aerobic interval training
Older adults will complete 8 weeks of high intensity aerobic interval exercise training.
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.
Experimental: Continuous moderate intensity exercise
Older adults will complete 8 weeks of continuous moderate intensity exercise training.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01883271

Contacts
Contact: Demetra D Christou, Ph.D 352-294-1715 ddchristou@ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Demetra D Christou, Ph.D    352-294-1715    ddchristou@ufl.edu   
Principal Investigator: Demetra D Christou, Ph.D         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Demetra D Christou, Ph.D University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01883271     History of Changes
Other Study ID Numbers: 551-2012
Study First Received: June 13, 2013
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 22, 2014