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Sleep Apnea, Cardiovascular and Exercise Study

Primary Purpose

Obstructive Sleep Apnea, Vascular Diseases, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exercise training
Sponsored by
Towson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, exercise training, vascular function

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Towson University Wellness Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Change in flow mediated dilation of the brachial artery
Flow mediated dilation (in %) of the brachial artery will be assessed by vascular ultrasound

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
July 11, 2017
Last Updated
September 9, 2019
Sponsor
Towson University
Collaborators
Pulmonary Critical Care Associates of Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT03219749
Brief Title
Sleep Apnea, Cardiovascular and Exercise Study
Official Title
Examining the Effects of Exercise on Vascular Function in Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 15, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Towson University
Collaborators
Pulmonary Critical Care Associates of Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Vascular Diseases, Obesity
Keywords
obstructive sleep apnea, exercise training, vascular function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Intervention
Arm Type
Experimental
Arm Description
Exercise training will take place three times per week for six weeks and involve both aerobic and resistance exercise.
Intervention Type
Behavioral
Intervention Name(s)
exercise training
Intervention 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.
Primary Outcome Measure Information:
Title
Change in flow mediated dilation of the brachial artery
Description
Flow mediated dilation (in %) of the brachial artery will be assessed by vascular ultrasound
Time Frame
This outcome will be assessed at baseline and at 6 weeks
Secondary Outcome Measure Information:
Title
exercise stress test
Description
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.
Time Frame
This outcome will be assessed at baseline and at 6 weeks
Title
dual energy X-ray absorptiometry
Description
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.
Time Frame
This outcome will be assessed at baseline and at 6 weeks
Title
blood draw
Description
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
Time Frame
This outcome will be assessed at baseline and at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Towson University Wellness Center
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Sleep Apnea, Cardiovascular and Exercise Study

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