Examining the Effects of Exercise on Vascular Function in Obstructive Sleep Apnea

Sleep Apnea, Cardiovascular and Exercise Study



Sponsors


Source

Towson University

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

Obstructive sleep apnea (OSA) results in vascular dysfunction, which increases the risk of
cardiovascular disease. In contrast, exercise confers cardioprotection through improvements
in vascular health. This proposal evaluates whether the beneficial effects of exercise on
vascular function are attenuated in obese individuals suffering from untreated OSA.

Detailed Description

Obstructive sleep apnea (OSA) is a serious medical condition that affects an estimated 15
million US adults and is characterized by repeated episodes of upper airway obstruction,
recurrent arousals and episodic oxyhemoglobin desaturations during sleep. These abnormalities
contribute to subclinical alterations in vascular function that increase the risk of
cardiovascular disease morbidity and mortality. In contrast, exercise decreases the risk of
cardiovascular events and the promotion of physical activity continues to be at the top of
our national public health agenda, as seen in the publication of the 1996 report of the US
Surgeon General on physical activity and health. While the exact mechanisms for this
protective benefit are not entirely clear, there is good evidence that exercise confers
cardioprotection through its direct impact on vascular endothelial function. The American
College of Sleep Medicine recommends exercise as a behavioral treatment option for OSA. Yet,
most clinical trials upon which this recommendation is based have focused on establishing the
effectiveness of lifestyle change (e.g., dietary induced weight loss and increased physical
activity participation) for improving OSA severity in obese individuals, whereas less
attention has been given to whether OSA moderates the effects of exercise on the
cardiovascular disease substrate. The overarching hypothesis of this study is that OSA
attenuates the beneficial effect of exercise on vascular function in obese individuals
suffering from untreated OSA. The aims of the study are to 1) examine parameters of vascular
function in obese persons with and without OSA, 2) evaluate the effects of an acute bout of
exercise on brachial artery flow mediated dilation in obese persons with and without OSA, and
3) examine the effects of 6 weeks of exercise training on vascular function among those with
and without OSA. These data will be immediately useful in clinical practice and inform how
clinicians prescribe exercise and implement lifestyle changes to reduce cardiovascular
disease risk in OSA patients.

Overall Status

Recruiting

Start Date

2017-01-15

Completion Date

2019-06-30

Primary Completion Date

2019-04-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Change in flow mediated dilation of the brachial artery
This outcome will be assessed at baseline and at 6 weeks

Secondary Outcome

Measure

Time Frame

exercise stress test
This outcome will be assessed at baseline and at 6 weeks
dual energy X-ray absorptiometry
This outcome will be assessed at baseline and at 6 weeks
blood draw
This outcome will be assessed at baseline and at 6 weeks

Enrollment

60

Conditions


Intervention

Intervention Type

Behavioral

Intervention Name


Description

Eligible participants will undergo 6 weeks of a combined aerobic and resistance exercise intervention. Training will take place 3 times per week for 1 hour. Forty minutes will be dedicated to aerobic training while 15 to 20 minutes will be devoted to resistance training.

Arm Group Label

Exercise Intervention


Eligibility

Criteria

Inclusion Criteria:

- BMI between 30 and 42

Exclusion Criteria:

- Apnea-hypopnea index > 60 events (confirmed with overnight sleep study)

- Currently participating in an exercise program as defined as a minimum of moderate
exercise > 30 minute/day, > 3 times or 90 minutes per week

- Participating in a weight loss program and NOT weight stable for 3 months

- History of heart disease

- Uncontrolled hypertension

- Cigarette smoking in the last 6 months

- Type 1 diabetes

- Women who are pregnant

- Currently using hormonal replacement therapy

- Comorbid conditions including concern, peripheral arterial disease, renal disease,
lung disease, thyroid diseases, osteoporosis and arthritis with chronic joint pain

Gender

All

Minimum Age

30 Years

Maximum Age

65 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Contact

Last Name

Devon A Dobrosielski, PhD

Phone

410-704-3630

Email

[email protected]


Location

Facility

Status

Contact

Investigator

Towson University Wellness Center
Towson Maryland 21204 United States
Recruiting
Last Name: Shavise Glascoe, MS
Phone: 410-704-4555
Email: [email protected]
Last Name: Devon A Dobrosielski, PhD
Role: Principal Investigator

Location Countries

Country

United States


Verification Date

2017-07-01

Lastchanged Date

2017-07-13

Firstreceived Date

2017-07-11

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Towson University

Investigator Full Name

Devon Dobrosielski

Investigator Title

Assistant Professor


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

1

Arm Group

Arm Group Label

Exercise Intervention

Arm Group Type

Experimental

Description

Exercise training will take place three times per week for six weeks and involve both aerobic and resistance exercise.


Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Primary Purpose

Treatment

Masking

No masking



ClinicalTrials.gov processed this data on July 17, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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