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Spinal Muscular Atrophy and Cardiac Autonomic Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cristina Marcia Dias, Centro Universitário Augusto Motta
ClinicalTrials.gov Identifier:
NCT01522079
First received: January 24, 2012
Last updated: January 26, 2012
Last verified: January 2012
History of Changes

January 24, 2012
January 26, 2012
January 2011
August 2011   (final data collection date for primary outcome measure)
Cardiac autonomic function [ Time Frame: Thirty minutes during air stacking manuever ] [ Designated as safety issue: Yes ]
Evaluation of heart rate variability in patients with spinal muscular atrophy
Same as current
Complete list of historical versions of study NCT01522079 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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
Both
5 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01522079
Dias
Yes
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