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Clinical Trials/NCT01522079
NCT01522079
Completed
Not Applicable

Spinal Muscular Atrophy and Cardiac Autonomic Function

Centro Universitário Augusto Motta0 sites9 target enrollmentJanuary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Muscular Atrophy
Sponsor
Centro Universitário Augusto Motta
Enrollment
9
Primary Endpoint
Cardiac autonomic function
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

Detailed Description

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%.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
October 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Centro Universitário Augusto Motta
Responsible Party
Principal Investigator
Principal Investigator

Cristina Marcia Dias

Professor DSc

Centro Universitário Augusto Motta

Eligibility Criteria

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

Outcomes

Primary Outcomes

Cardiac autonomic function

Time Frame: Thirty minutes during air stacking manuever

Evaluation of heart rate variability in patients with spinal muscular atrophy

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