- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00207857
Test-Retest Reliability of Pulmonary Function Tests in Patients With Duchenne's Muscular Dystrophy
February 2, 2015 updated by: Children's Healthcare of Atlanta
Nearly all patients with Duchenne's 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.
Study Overview
Status
Withdrawn
Conditions
Detailed Description
All patients with DMD have routine PFT's 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 PFT's, 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 PFT's, 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 Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Georgia
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Atlanta, Georgia, United States, 30342
- Children's Healthcare of Atlanta @ Scottish Rite
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male
- Duchenne's Muscular Dystrophy with diagnosed confirmed by a neurologist
- No longer able to ambulate for any meaningful amount of time
- No previous spinal operation
Exclusion Criteria:
- Any other type of muscular dystrophy or spinal muscular atrophy
- Tracheotomy
- Contractures of the upper extremities that would preclude using arm span as an estimation for height
- Previous spinal surgery
- Asthma, recurrent pneumonia, or other chronic lung disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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With and Without PFTs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PFT training
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tim Schrader, MD, Children's Orthopaedics of Atlanta
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Primary Completion (Actual)
August 1, 2005
Study Completion (Anticipated)
August 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
February 4, 2015
Last Update Submitted That Met QC Criteria
February 2, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Duchenne's Muscular Dystrophy
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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