Respiratory Muscle Strength in Patients With NMD

This study is currently recruiting participants.
Verified January 2014 by University of Florida
Sponsor:
Collaborator:
Acid Maltase Deficiency Association
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01555905
First received: March 14, 2012
Last updated: January 16, 2014
Last verified: January 2014

March 14, 2012
January 16, 2014
April 2011
April 2015   (final data collection date for primary outcome measure)
VT/FVC [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The primary endpoints for inspiratory muscle training efficacy will include respiratory muscle strength.
Same as current
Complete list of historical versions of study NCT01555905 on ClinicalTrials.gov Archive Site
VT/FVC [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary outcome measures include respiratory function and breathing pattern during loaded breathing
Same as current
Not Provided
Not Provided
 
Respiratory Muscle Strength in Patients With NMD
Respiratory Muscle Strength and Function in Patients With Neuromuscular Disease

Inspiratory Muscle strength training (IMST) will significantly improve maximal inspiratory pressure and pulmonary function in patients with neuromuscular disease and respiratory muscle contractile dysfunction.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Neuromuscular Disease
Device: Threshold PEP or IMT device Phillips-Respironics
The subject will be instructed to take 8-15 deep, forceful breaths through the Threshold device, followed by at least 3 minutes of rest. The process will be repeated 3 more times for a total of 4 sets of 8-15 breaths. IMST will be completed three to five days per week, based upon the subject's daily baseline level of fatigue.
Experimental: Exercise
Intervention: Device: Threshold PEP or IMT device Phillips-Respironics
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Neuromuscular Disease

Exclusion Criteria:

  • Above or below age range.
  • No acute illness at time of study.
  • Use of tobacco products.
  • FVC within normal limits.
  • No evidence of Neuromuscular Disease.
Both
12 Months to 65 Years
No
Not Provided
United States
 
NCT01555905
UF-IRB 147-2011
No
University of Florida
University of Florida
Acid Maltase Deficiency Association
Principal Investigator: Barbara K Smith, PhD, PT University of Florida
University of Florida
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP