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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01883271
Other study ID # IRB201700044
Secondary ID 551-2012
Status Completed
Phase N/A
First received
Last updated
Start date May 2013
Est. completion date February 21, 2019

Study information

Verified date February 2019
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 21, 2019
Est. primary completion date February 21, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 79 Years
Eligibility 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 Design


Related Conditions & MeSH terms


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.
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.

Locations

Country Name City State
United States University of Florida Gainesville Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in vascular endothelial function Brachial flow-mediated dilation using ultrasonography At baseline and after 8 weeks of exercise training
Secondary Change in factors related with endothelial function Blood and cellular markers of oxidative stress and inflammation At baseline and after 8 weeks of exercise training
Secondary Change in arterial stiffness Arterial stiffness and wave reflection will be measured using the SphygmoCor device At baseline and after 8 weeks of exercise training
Secondary Change in cardiac function Left ventricular systolic and diastolic function will be measured using echocardiography At baseline and after 8 weeks of exercise training
Secondary Change in maximal oxygen consumption 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
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