Test-Retest Reliability of Pulmonary Function Tests in Patients With Duchenne's Muscular Dystrophy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Children's Healthcare of Atlanta.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00207857
First received: September 13, 2005
Last updated: September 6, 2006
Last verified: September 2006
  Purpose

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.


Condition
Duchenne's Muscular Dystrophy
Scoliosis

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Test-Retest Reliability of Pulmonary Function Tests in Patients With Duchenne's Muscular Dystrophy

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Estimated Enrollment: 100
Study Start Date: March 2004
Estimated Study Completion Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   6 Years to 21 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207857

Contacts
Contact: Elena Morales, BS elena.morales@choa.org

Locations
United States, Georgia
Children's Healthcare of Atlanta @ Scottish Rite Recruiting
Atlanta, Georgia, United States, 30342
Contact: Elena Morales, BS       elena.morales@choa.org   
Principal Investigator: Tim Schrader, MD         
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Tim Schrader, MD Children's Orthopaedics of Atlanta
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00207857     History of Changes
Other Study ID Numbers: Duchenne's Muscular Dystrophy
Study First Received: September 13, 2005
Last Updated: September 6, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Healthcare of Atlanta:
Duchenne's Muscular Dystrophy
Scoliosis

Additional relevant MeSH terms:
Genetic Diseases, X-Linked
Muscular Dystrophy, Duchenne
Muscular Dystrophies
Scoliosis
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Spinal Curvatures
Spinal Diseases
Bone Diseases

ClinicalTrials.gov processed this record on July 23, 2014