Spinal Muscular Atrophy and Cardiac Autonomic Function

Spinal Muscular Atrophy Clinical Trial

Official title:

Spinal Muscular Atrophy and Cardiac Autonomic Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522079
• Other study ID #: Dias
• Status: Completed
• Phase: N/A
• First received: January 24, 2012
• Last updated: January 26, 2012
• Start date: January 2011
• Est. completion date: October 2011

Study information

• Verified date: January 2012
• Source: Centro Universitário Augusto Motta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 25 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophy
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Spinal Muscular Atrophy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitário Augusto Motta

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac autonomic function	Evaluation of heart rate variability in patients with spinal muscular atrophy	Thirty minutes during air stacking manuever	Yes