## Protocol Section
### Identification Module
**NCT ID:** NCT01522079

**Brief Title:** Spinal Muscular Atrophy and Cardiac Autonomic Function

**Official Title:** Spinal Muscular Atrophy and Cardiac Autonomic Function

#### Organization Study ID Info
**ID:** Dias
#### Organization
**Class:** OTHER
**Full Name:** Centro Universitário Augusto Motta
### Status Module
#### Completion Date
**Date:** 2011-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-01-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-01-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-08

**Type:** ACTUAL

#### Start Date
**Date:** 2011-01

**Status Verified Date:** 2012-01

#### Study First Post Date
**Date:** 2012-01-31
**Type:** ESTIMATED
**Study First Submit Date:** 2012-01-24
**Study First Submit QC Date:** 2012-01-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centro Universitário Augusto Motta

#### Responsible Party

**Investigator Affiliation:** Centro Universitário Augusto Motta

**Investigator Full Name:** Cristina Marcia Dias

**Investigator Title:** Professor DSc

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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%.

### Conditions Module

**Conditions:**

- Spinal Muscular Atrophy

**Keywords:**

- spinal muscular atrophy

- heart rate variability

- posture

- air stacking

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 9

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: Air stacking manuever

**Label:** Air stacking

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Air stacking

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

**Name:** Air stacking manuever

**Other Names:**

- HRV during air stacking

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Evaluation of heart rate variability in patients with spinal muscular atrophy

**Measure:** Cardiac autonomic function

**Time Frame:** Thirty minutes during air stacking manuever

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 25 Years

**Minimum Age:** 5 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Centro Universitário Augusto Motta

**Name:** Cristina M Dias, PT - PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000020879

- Term: Neuromuscular Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000013118

- Term: Spinal Cord Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000016472

- Term: Motor Neuron Disease

- ID: D000019636

- Term: Neurodegenerative Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12090

- Name: Muscular Atrophy

- Relevance: HIGH

- As Found: Muscular Atrophy

- ID: M12091

- Name: Muscular Atrophy, Spinal

- Relevance: HIGH

- As Found: Spinal Muscular Atrophy

- ID: M4589

- Name: Atrophy

- Relevance: HIGH

- As Found: Atrophy

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M22619

- Name: Neuromuscular Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M15915

- Name: Spinal Cord Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M18879

- Name: Motor Neuron Disease

- Relevance: LOW

- As Found: Unknown

- ID: M4024

- Name: Amyotrophic Lateral Sclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5342

- Name: Spinal Muscular Atrophy

- Relevance: HIGH

- As Found: Spinal Muscular Atrophy

- ID: T349

- Name: Amyotrophic Lateral Sclerosis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009133

- Term: Muscular Atrophy

- ID: D000009134

- Term: Muscular Atrophy, Spinal

- ID: D000001284

- Term: Atrophy

### Misc Info Module

- Version Holder: 2024-05-24
