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Spinal Muscular Atrophy and Cardiac Autonomic Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01522079
First Posted: January 31, 2012
Last Update Posted: January 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cristina Marcia Dias, Centro Universitário Augusto Motta
  Purpose

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 Intervention
Spinal Muscular Atrophy Procedure: Air stacking manuever

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spinal Muscular Atrophy and Cardiac Autonomic Function

Resource links provided by NLM:


Further study details as provided by Cristina Marcia Dias, Centro Universitário Augusto Motta:

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


Enrollment: 9
Study Start Date: January 2011
Study Completion Date: October 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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%.

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Responsible Party: Cristina Marcia Dias, Professor DSc, Centro Universitário Augusto Motta
ClinicalTrials.gov Identifier: NCT01522079     History of Changes
Other Study ID Numbers: Dias
First Submitted: January 24, 2012
First Posted: January 31, 2012
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