Longitudinal Assessment of Exercise Capacity and Vascular Function in Patients With CF
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|ClinicalTrials.gov Identifier: NCT03338595|
Recruitment Status : Active, not recruiting
First Posted : November 9, 2017
Last Update Posted : March 24, 2020
|Condition or disease|
Cystic Fibrosis (CF) is the most common fatal genetic disease in North America. The most disturbing aspect of CF is the associated premature death, most often due to respiratory complications. Clinical manifestations of CF include not only lung dysfunction, but many other systemic consequences as well. Systemic oxidative stress and exercise intolerance are established phenotypes in patients with CF. Additionally, for the first time the investigators have recently published the presence of systemic endothelial dysfunction in a cohort of young patients with CF who exhibited normal oxygen saturation and spirometric function.
Exercise intolerance, the limitation of the ability to perform exercise at the expected level, has been shown to predict mortality in patients with CF independent of lung function. Exercise capacity (VO2 peak), an objective measurement of exercise tolerance, drops approximately 5-8% per year in patients with CF. This excessive decay in exercise capacity not only leads to more pulmonary infections and deterioration of lung function, it represents a 5-8 fold decline compared to healthy sedentary adults. Preventing the excessive annual reduction in exercise capacity is essential to increasing the quality of life and longevity of patients with CF. However, a critical barrier to improving exercise capacity in CF is the investigators lack of knowledge regarding the different physiological mechanisms that contribute to exercise intolerance. It is important to emphasize that decreases in lung function (FEV1) do not always contribute to reductions in VO2 peak. Furthermore, less than 2% of patients who have an FEV1 greater than 50% predicted will have a significant drop in hemoglobin oxygen saturation (SpO2) during maximal exercise. These data suggest that mechanisms other than lung function induced hypoxemia may be contributing to exercise intolerance in patients with CF.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Longitudinal Assessment of Exercise Capacity and Vascular Function in Patients With CF|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
- Maximal exercise capacity [ Time Frame: 1 year ]Subjects will perform the maximal exercise tests on an electronically braked cycle ergometer using the Godfrey protocol. Expired gases will be collected using a Parvo Medics True One metabolic cart for determination of exercise capacity (VO2 peak).
- Flow mediated dilation [ Time Frame: 1 year ]The brachial artery FMD test will be performed according to the recent tutorial on the ultrasonic assessment of FMD and shear rate will be calculated as the stimulus of the vasodilatory response. Briefly, subjects will lie in the supine position for 20 minutes to obtain hemodynamic steady state. A blood pressure cuff (Hokanson) will be placed around the forearm (distal to the Doppler transducer) and rapidly inflated to 250 mmHg for 5 minutes (circulatory arrest). Simultaneous ultrasound images of the vessel (B-mode) and Doppler waveforms will be collected 10 seconds prior to and for 2 minutes following deflation of the cuff.
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338595
|United States, Georgia|
|Georgia Prevention Institute|
|Augusta, Georgia, United States, 30912|
|Principal Investigator:||Ryan Harris, PhD||Augusta University|