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Spinal Muscular Atrophy and Cardiac Autonomic Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cristina Marcia Dias, Centro Universitário Augusto Motta
ClinicalTrials.gov Identifier:
NCT01522079
First received: January 24, 2012
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Spinal Muscular Atrophy and Cardiac Autonomic Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centro Universitário Augusto Motta:

Primary Outcome Measures:
  • Cardiac autonomic function [ Time Frame: Thirty minutes during air stacking manuever ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   5 Years to 25 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522079

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

No publications provided

Responsible Party: Cristina Marcia Dias, Professor DSc, Centro Universitário Augusto Motta
ClinicalTrials.gov Identifier: NCT01522079     History of Changes
Other Study ID Numbers: Dias
Study First Received: January 24, 2012
Last Updated: January 26, 2012
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on May 16, 2013