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Spinal Muscular Atrophy and Cardiac Autonomic Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01522079
First Posted: January 31, 2012
Last Update Posted: January 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cristina Marcia Dias, Centro Universitário Augusto Motta
January 24, 2012
January 31, 2012
January 31, 2012
January 2011
August 2011   (Final data collection date for primary outcome measure)
Cardiac autonomic function [ Time Frame: Thirty minutes during air stacking manuever ]
Evaluation of heart rate variability in patients with spinal muscular atrophy
Same as current
No Changes Posted
Not Provided
Not Provided
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Spinal Muscular Atrophy and Cardiac Autonomic Function
Spinal Muscular Atrophy and Cardiac Autonomic Function

Respiratory dysfunction is the major cause of morbidity and mortality in patients with spinal muscular atrophy (SMA). Air stacking is a clearance airway technique frequently used but its effects on cardiac autonomic function in patients with spinal muscle atrophy is not clear.

Objective: To evaluate the acute effect of air stacking and posture on cardiac autonomic function in patients with spinal muscular atrophy types II and III.

Methods: Patients with spinal muscle atrophy type II and III will be recruited. Electrocardiogram signals will be recorded for analyses of heart rate variability during air stacking in supine and sitting position.

Background: Respiratory dysfunction is the major cause of morbidity and mortality in patients with spinal muscular atrophy. Air stacking is a clearance airway technique frequently used but its effects on cardiac autonomic function in patients with spinal muscle atrophy is not clear.

Objective: To evaluate the acute effect of air stacking and posture on cardiac autonomic function in patients with spinal muscular atrophy types II and III.

Methods: Patients with spinal muscle atrophy type II and III will be recruited. Electrocardiogram signals will be recorded for analyses of heart rate variability during air stacking in supine and sitting position. Data will collected before, during and after air stacking and will be compared using Anova Repeated Measures or Kruskal-Wallis Anova on Ranks, followed by Tukey test. The relationship between heart rate variability indexes and age will be evaluated by Pearson correlation. Significant level will be set at 5%.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Spinal Muscular Atrophy
Procedure: Air stacking manuever
Electrocardiogram signals were recorded for analyses of heart rate variability during air stacking in supine and sitting position
Other Name: HRV during air stacking
Experimental: Air stacking
Electrocardiogram signals were recorded for analyses of heart rate variability during air stacking in supine and sitting position.
Intervention: Procedure: Air stacking manuever
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
October 2011
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis of SMA types II and III,
  • absence of acute respiratory disease in the last two weeks,
  • agreement to participate in the study,
  • according written informed consent and
  • at least 5 years old.

Exclusion Criteria:

  • respiratory disease in the last two weeks
Sexes Eligible for Study: All
5 Years to 25 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01522079
Dias
Yes
Not Provided
Not Provided
Cristina Marcia Dias, Centro Universitário Augusto Motta
Centro Universitário Augusto Motta
Not Provided
Principal Investigator: Cristina M Dias, PT - PhD Centro Universitário Augusto Motta
Centro Universitário Augusto Motta
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP