Sleep Apnea, Cardiovascular and Exercise Study

NCT03219749 | Completed

• 1 other identifier: 1R15HL133884
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Vascular Diseases; Obesity

Keywords

obstructive sleep apnea; exercise training; vascular function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Exercise Intervention

EXPERIMENTAL

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

Behavioral: exercise training

Interventions

exercise training BEHAVIORAL

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.

Exercise Intervention

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- BMI between 30 and 42

You may not qualify if:

• 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

Sponsors & Collaborators

• Towson University: lead
• Pulmonary Critical Care Associates of Baltimore: collaborator

Study Sites (1)

Towson University Wellness Center

Towson, Maryland, 21204, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Vascular Diseases; Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 17, 2017
• Study Start: January 15, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 30, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-09

Locations

US (1)