Spinal Muscular Atrophy and Cardiac Autonomic Function

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01522079

Enrollment

Registered

2012-01-31

Start date

2011-01-31

Completion date

2011-10-31

Last updated

2012-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Muscular Atrophy

Keywords

spinal muscular atrophy, heart rate variability, posture, air stacking

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%.

Interventions

PROCEDUREAir stacking manuever

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 25 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Cardiac autonomic function	Thirty minutes during air stacking manuever	Evaluation of heart rate variability in patients with spinal muscular atrophy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026