Clinical trial NCT03219749: Sleep Apnea, Cardiovascular and Exercise Study
Official title: Examining the Effects of Exercise on Vascular Function in Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Vascular Diseases
Obesity
Keywords: obstructive sleep apnea
exercise training
vascular function
Lead sponsor: Towson University
Sponsor class: OTHER
Collaborators: name: Pulmonary Critical Care Associates of Baltimore
First posted: 2017-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in flow mediated dilation of the brachial artery
timeFrame: This outcome will be assessed at baseline and at 6 weeks
Secondary outcomes:
measure: exercise stress test
timeFrame: This outcome will be assessed at baseline and at 6 weeks
measure: dual energy X-ray absorptiometry
timeFrame: This outcome will be assessed at baseline and at 6 weeks
measure: blood draw
timeFrame: This outcome will be assessed at baseline and at 6 weeks
Other outcomes:
Locations:
city: Towson
country: United States
facility: Towson University Wellness Center
state: Maryland
Study officials:
References: