Effects Of Noninvasive Ventilation On Functional Capacity Of Patients With Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT01987271|
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : November 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Device: Noninvasive Ventilation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects Of Noninvasive Ventilation During The Treadmill Walking Test On Cardiorespiratory System, Walk Distance, And Thoracoabdominal Kinematics Of Patients With Cystic Fibrosis: Clinical Randomized Controlled Trial.|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Experimental: With noninvasive ventilation
When patients do the six minute walk test with the noninvasive ventilation.
Device: Noninvasive Ventilation
A randomized plan define the order in which patients would execute the 6MWT, with or without NIV.
No Intervention: Without noninvasive ventilation
When patients do the six minute walk test without noninvasive ventilation.
- Walk Distance (WD) on six minute walk test (6MWT) [ Time Frame: 2 days ]Patients allocated to group 1 (G1) initiated the 6MWT without noninvasive ventilation (NIV) to subsequently perform the test with ventilatory support, since those allocated to group 2 (G2) underwent the tests in reverse order. Rest period between tests: 24 - 48 hours. At the end of the test, the walk distance on a treadmill is recorded.
- Forced expiratory volume in the first second (FEV1) [ Time Frame: 2 days ]The patients do the walk test a twice on a week. Before and after each test, this variable is recorded.
- Rib cage volumes [ Time Frame: 2 days ]This variable is assessed by Optoeletronic Pletismography (BTS Bioengineering, Italy) before and after both tests, with and without NIV, recording the tidal volume, pulmonary rib cage volume, abdominal rib cage and abdominal volume (Vt, Vrcp Vrca, Vab).
- Forced vital capacity (FVC) [ Time Frame: 2 days ]The patients do the walk test a twice on the same week. Before and after each test, this variable is recorded.
- Forced expiratory flow of 25% to 75% of FVC (FEF 25-75) [ Time Frame: 2 days ]The patients do the walk test a twice on the same week. Before and after each test, this variable is recorded.
- Respiratory cicle time [ Time Frame: 2 days ]This following variable is assessed by Optoeletronic Pletismography (BTS Bioengineering, Italy) before and after both tests, with and without NIV, recording the respiratory rate (RR), inspiratory time (Ti), expiratory time (Te), total ventilatory cycle time (Ttot) and duty cycle, which represents the Ti/Ttot ratio.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987271
|Instituto de Medicina Intergral Prof. Fernando Fiqueira|
|Recife, Pernambuco, Brazil, 50070-550|