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Spinal Muscular Atrophy and Cardiac Autonomic Function

NCT ID: NCT01522079

Last Updated: 2012-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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%.

Conditions

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Spinal Muscular Atrophy

Keywords

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spinal muscular atrophy heart rate variability posture air stacking

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Air stacking

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

Group Type EXPERIMENTAL

Air stacking manuever

Intervention Type PROCEDURE

Electrocardiogram signals were recorded for analyses of heart rate variability during air stacking in supine and sitting position

Interventions

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Air stacking manuever

Electrocardiogram signals were recorded for analyses of heart rate variability during air stacking in supine and sitting position

Intervention Type PROCEDURE

Other Intervention Names

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HRV during air stacking

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centro Universitário Augusto Motta

OTHER

Sponsor Role lead

Responsible Party

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Cristina Marcia Dias

Professor DSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cristina M Dias, PT - PhD

Role: PRINCIPAL_INVESTIGATOR

Centro Universitário Augusto Motta

Other Identifiers

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Dias

Identifier Type: -

Identifier Source: org_study_id