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Spinal Muscular Atrophy and Cardiac Autonomic Function

Primary Purpose

Spinal Muscular Atrophy

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Air stacking manuever

About this trial

This is an interventional treatment trial for Spinal Muscular Atrophy focused on measuring spinal muscular atrophy, heart rate variability, posture, air stacking

Eligibility Criteria

5 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Air stacking

Arm Description

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

Outcomes

Primary Outcome Measures

Cardiac autonomic function

Evaluation of heart rate variability in patients with spinal muscular atrophy

Secondary Outcome Measures

Full Information

NCT ID

NCT01522079

First Posted

January 24, 2012

Last Updated

January 26, 2012

Sponsor

Centro Universitário Augusto Motta

1. Study Identification

Unique Protocol Identification Number

NCT01522079

Brief Title

Spinal Muscular Atrophy and Cardiac Autonomic Function

Official Title

Spinal Muscular Atrophy and Cardiac Autonomic Function

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centro Universitário Augusto Motta

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Muscular Atrophy

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Air stacking

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Air stacking manuever

Other Intervention Name(s)

HRV during air stacking

Intervention Description

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

Primary Outcome Measure Information:

Title

Cardiac autonomic function

Description

Evaluation of heart rate variability in patients with spinal muscular atrophy

Time Frame

Thirty minutes during air stacking manuever

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cristina M Dias, PT - PhD

Organizational Affiliation

Centro Universitário Augusto Motta

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Spinal Muscular Atrophy and Cardiac Autonomic Function

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