Spinal Muscular Atrophy and Cardiac Autonomic Function

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2011

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%.

Interventions

  • Procedure: Air stacking manuever
    • Electrocardiogram signals were recorded for analyses of heart rate variability during air stacking in supine and sitting position

Arms, Groups and Cohorts

  • Experimental: Air stacking
    • Electrocardiogram signals were recorded for analyses of heart rate variability during air stacking in supine and sitting position.

Clinical Trial Outcome Measures

Primary Measures

  • Cardiac autonomic function
    • Time Frame: Thirty minutes during air stacking manuever
    • Evaluation of heart rate variability in patients with spinal muscular atrophy

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 25 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Centro Universitário Augusto Motta
  • Provider of Information About this Clinical Study
    • Principal Investigator: Cristina Marcia Dias, Professor DSc – Centro Universitário Augusto Motta
  • Overall Official(s)
    • Cristina M Dias, PT – PhD, Principal Investigator, Centro Universitário Augusto Motta

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