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Sleep Apnea, Cardiovascular and Exercise Study

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Devon Dobrosielski, Towson University
Sponsor:
Collaborator:
Pulmonary Critical Care Associates of Baltimore
Information provided by (Responsible Party):
Devon Dobrosielski, Towson University
ClinicalTrials.gov Identifier:
NCT03219749
First received: July 11, 2017
Last updated: July 13, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention
Obstructive Sleep Apnea Vascular Diseases Obesity Behavioral: exercise training

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Examining the Effects of Exercise on Vascular Function in Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Devon Dobrosielski, Towson University:

Primary Outcome Measures:
  • Change in flow mediated dilation of the brachial artery [ Time Frame: This outcome will be assessed at baseline and at 6 weeks ]
    Flow mediated dilation (in %) of the brachial artery will be assessed by vascular ultrasound


Secondary Outcome Measures:
  • exercise stress test [ Time Frame: This outcome will be assessed at baseline and at 6 weeks ]
    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.

  • dual energy X-ray absorptiometry [ Time Frame: This outcome will be assessed at baseline and at 6 weeks ]
    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.

  • blood draw [ Time Frame: This outcome will be assessed at baseline and at 6 weeks ]
    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


Estimated Enrollment: 60
Actual Study Start Date: January 15, 2017
Estimated Study Completion Date: June 30, 2019
Estimated Primary Completion Date: April 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03219749

Contacts
Contact: Devon A Dobrosielski, PhD 410-704-3630 savestudy@towson.edu

Locations
United States, Maryland
Towson University Wellness Center Recruiting
Towson, Maryland, United States, 21204
Contact: Shavise Glascoe, MS    410-704-4555    sglascoe@towson.edu   
Principal Investigator: Devon A Dobrosielski, PhD         
Sponsors and Collaborators
Towson University
Pulmonary Critical Care Associates of Baltimore
  More Information

Responsible Party: Devon Dobrosielski, Assistant Professor, Towson University
ClinicalTrials.gov Identifier: NCT03219749     History of Changes
Other Study ID Numbers: 1R15HL133884 ( U.S. NIH Grant/Contract )
Study First Received: July 11, 2017
Last Updated: July 13, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Devon Dobrosielski, Towson University:
obstructive sleep apnea
exercise training
vascular function

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Vascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 17, 2017