Clinical trial NCT01883271: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in vascular endothelial function
timeFrame: At baseline and after 8 weeks of exercise training
Secondary outcomes:
measure: Change in factors related with endothelial function
timeFrame: At baseline and after 8 weeks of exercise training
measure: Change in arterial stiffness
timeFrame: At baseline and after 8 weeks of exercise training
measure: Change in cardiac function
timeFrame: At baseline and after 8 weeks of exercise training
measure: Change in maximal oxygen consumption
timeFrame: At baseline and after 8 weeks of exercise training
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Demetra D Christou, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: