Spinal Muscular Atrophy and Cardiac Autonomic Function
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 9
- Primary Endpoint
- Cardiac autonomic function
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Cardiac autonomic function
Time Frame: Thirty minutes during air stacking manuever
Evaluation of heart rate variability in patients with spinal muscular atrophy
Secondary Outcomes
No secondary outcomes reported
Investigators
Cristina Marcia Dias
Professor DSc
Centro Universitário Augusto Motta