Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00207857
Status:
WITHDRAWN
Last Update Posted:
2015-02-04
First Post:
2005-09-13
Brief Title:
Test-Retest Reliability of Pulmonary Function Tests in Patients With Duchennes Muscular Dystrophy
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Test-Retest Reliability of Pulmonary Function Tests in Patients With Duchennes Muscular Dystrophy
Status:
WITHDRAWN
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nearly all patients with Duchennes Muscular Dystrophy DMD have scoliosis Posterior instrumented spinal fusion which is a surgery to correct scoliosis has been shown to improve quality of life and satisfaction of both parents and families The progressive muscular weakness leads to the development of scoliosis soon after the child has become unable to walk The muscular weakness and scoliosis also affect the pulmonary function of these children Pulmonary Function Tests PFT have been used to determine pulmonary fitness prior to surgery as a way to determine how well or if the child will tolerate surgery Children with poor results on the PFT are determined to be too fragile to tolerate such a large operation The physicians conducting this study feel that the PFT may be inaccurate and that this may not be the best single test to determine pulmonary fitness The physicians conducting the study think things like the time of day the study is done how tired you are when you complete the test and how well you understand the test may affect the results of the test
Detailed Description:
All patients with DMD have routine PFTs every six months as standard of care You will be randomized in to one of two groups The group assignment will be chosen by chance similar to flipping a coin If you are assigned to group one you will first have your regularly scheduled PFT in the morning You will be asked to complete a second PFT that afternoon as least 4 hours after the first PFT You will then be asked to come back to the clinic in two weeks and repeat these PFTs once in the morning and once in the afternoon at least 4 hours apart Each PFT will take approximately 10 to 15 minutes If you are assigned to group two you will have your regularly scheduled PFT in the morning and then a second test in the afternoon at least four hours after the first test After the second PFT you will receive training from a Respiratory Therapist You will receive teaching handouts to take home and an incentive spirometer and peak flow meter to practice with You will be asked to practice these tests 2 times a day and record your results You will then be asked to come back to the clinic in two weeks to repeat 2 PFTs once in the morning and again at least 4 hours later All participants will be asked how they feel at the time of testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None