Respiratory Muscle Strength in Patients With NMD

This study is currently recruiting participants.

Verified November 2012 by University of Florida

Sponsor:

Information provided by (Responsible Party):

University of Florida

ClinicalTrials.gov Identifier:

NCT01555905

First received: March 14, 2012

Last updated: November 28, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 14, 2012

Last Updated Date

November 28, 2012

Start Date ^ICMJE

April 2011

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

VT/FVC [ Time Frame: 3 months ] [ Designated as safety issue: No ]

The primary endpoints for inspiratory muscle training efficacy will include respiratory muscle strength.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01555905 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

VT/FVC [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary outcome measures include respiratory function and breathing pattern during loaded breathing

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Respiratory Muscle Strength in Patients With NMD

Official Title ^ICMJE

Respiratory Muscle Strength and Function in Patients With Neuromuscular Disease

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Neuromuscular Disease

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Exercise

Intervention: Device: Threshold PEP or IMT device Phillips-Respironics

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2014

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

12 Months to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01555905

Other Study ID Numbers ^ICMJE

UF-IRB 147-2011

Has Data Monitoring Committee

Responsible Party

University of Florida

Study Sponsor ^ICMJE

University of Florida

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Barbara K Smith, PhD, PT

University of Florida

Information Provided By

University of Florida

Verification Date

November 2012

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

To Top