NCT01522079

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

7 months

First QC Date

January 24, 2012

Last Update Submit

January 26, 2012

Conditions

Spinal Muscular Atrophy

Keywords

spinal muscular atrophyheart rate variabilitypostureair stacking

Outcome Measures

Primary Outcomes (1)

  • Cardiac autonomic function

    Evaluation of heart rate variability in patients with spinal muscular atrophy

    Thirty minutes during air stacking manuever

Study Arms (1)

Air stacking

EXPERIMENTAL

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

Procedure: Air stacking manuever

Interventions

Air stacking manueverPROCEDURE

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

Also known as: HRV during air stacking
Air stacking

Eligibility Criteria

Age5 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • respiratory disease in the last two weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesNeuromuscular Diseases

Study Officials

  • Cristina M Dias, PT - PhD

    Centro Universitário Augusto Motta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor DSc

Study Record Dates

First Submitted

January 24, 2012

First Posted

January 31, 2012

Study Start

January 1, 2011

Primary Completion

August 1, 2011

Study Completion

October 1, 2011

Last Updated

January 31, 2012

Record last verified: 2012-01