Sleep Apnea, Cardiovascular and Exercise Study

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

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.

Study Overview

• Status: Completed
• Conditions: Vascular Diseases; Obesity; Obstructive Sleep Apnea
• Intervention / Treatment: Behavioral: exercise training

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Towson, Maryland, United States, 21204
      • Towson University Wellness Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Intervention; Exercise training will take place three times per week for six weeks and involve both aerobic and resistance exercise.	Behavioral: exercise training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in flow mediated dilation of the brachial artery	Flow mediated dilation (in %) of the brachial artery will be assessed by vascular ultrasound	This outcome will be assessed at baseline and at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
exercise stress test	The participant will walk on a treadmill. The treadmill speed and grade will continue to increase every 3 minutes until the participant can not continue due to fatigue. Physical fitness will be determined by measuring the amount of time the individual is able to continue on the treadmill before stopping.	This outcome will be assessed at baseline and at 6 weeks
dual energy X-ray absorptiometry	The research participant lies on an examination table for approximately 10 minutes, during which time an X-ray type device scans the body and determines how much body mass is composed of fat tissue. This enables the investigator to monitor % body fat and determine if the exercise intervention influences body weight.	This outcome will be assessed at baseline and at 6 weeks
blood draw	Markers of inflammation (e.g., C reactive protein, interleukin 6) will be assessed with chemical assays using a sample of blood drawn from the participant	This outcome will be assessed at baseline and at 6 weeks

Collaborators and Investigators

• Sponsor: Towson University
• Collaborators: Pulmonary Critical Care Associates of Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2017
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 17, 2017

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; exercise training; vascular function
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Vascular Diseases; Apnea
• Other Study ID Numbers: 1R15HL133884 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No