Spinal Muscular Atrophy and Cardiac Autonomic Function

Not Applicable

Completed

• Conditions: Spinal Muscular Atrophy
• Interventions: Procedure: Air stacking manuever

• Registration Number: NCT01522079
• Lead Sponsor: Centro Universitário Augusto Motta

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%.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-08
• Study Completion: 2011-10
• Status Verified: 2012-01
• Study First Submitted: 2012-01-24
• Study First Submitted QC: 2012-01-26
• Last Update Submitted: 2012-01-26
• Study First Posted: 2012-01-31
• Last Update Posted: 2012-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Air stacking	Air stacking manuever	Electrocardiogram signals were recorded for analyses of heart rate variability during air stacking in supine and sitting position.

Primary Outcome Measures

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