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Spinal Muscular Atrophy and Cardiac Autonomic Function

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ClinicalTrials.gov Identifier: NCT01522079
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : January 31, 2012
Sponsor:
Information provided by (Responsible Party):
Cristina Marcia Dias, 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.


Condition or disease Intervention/treatment Phase
Spinal Muscular Atrophy Procedure: Air stacking manuever Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spinal Muscular Atrophy and Cardiac Autonomic Function
Study Start Date : January 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : October 2011


Arm Intervention/treatment
Experimental: Air stacking
Electrocardiogram signals were recorded for analyses of heart rate variability during air stacking in supine and sitting position.
Procedure: Air stacking manuever
Electrocardiogram signals were recorded for analyses of heart rate variability during air stacking in supine and sitting position
Other Name: HRV during air stacking




Primary Outcome Measures :
  1. Cardiac autonomic function [ Time Frame: Thirty minutes during air stacking manuever ]
    Evaluation of heart rate variability in patients with spinal muscular atrophy



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Ages Eligible for Study:   5 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522079


Sponsors and Collaborators
Centro Universitário Augusto Motta
Investigators
Principal Investigator: Cristina M Dias, PT - PhD Centro Universitário Augusto Motta

Responsible Party: Cristina Marcia Dias, Professor DSc, Centro Universitário Augusto Motta
ClinicalTrials.gov Identifier: NCT01522079     History of Changes
Other Study ID Numbers: Dias
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by Cristina Marcia Dias, Centro Universitário Augusto Motta:
spinal muscular atrophy
heart rate variability
posture
air stacking

Additional relevant MeSH terms:
Atrophy
Muscular Atrophy
Muscular Atrophy, Spinal
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Motor Neuron Disease
Neurodegenerative Diseases
Neuromuscular Diseases