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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01522079
Other study ID # Dias
Secondary ID
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


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
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