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Respiratory Muscle Strength in Patients With NMD (RMST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01555905
Recruitment Status : Recruiting
First Posted : March 16, 2012
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):

March 14, 2012
March 16, 2012
October 11, 2017
April 2011
June 2020   (Final data collection date for primary outcome measure)
Maximal respiratory pressure [ Time Frame: 3 months ]
The primary endpoints for inspiratory muscle training efficacy will be maximal respiratory pressure tests, a measure of respiratory strength.
VT/FVC [ Time Frame: 3 months ]
The primary endpoints for inspiratory muscle training efficacy will include respiratory muscle strength.
Complete list of historical versions of study NCT01555905 on ClinicalTrials.gov Archive Site
Peak flow volumes during loaded breaths [ Time Frame: 3 months ]
Secondary outcome measures include respiratory function and breathing pattern during loaded breathing against standard resistances.
VT/FVC [ Time Frame: 3 months ]
Secondary outcome measures include respiratory function and breathing pattern during loaded breathing
Not Provided
Not Provided
 
Respiratory Muscle Strength in Patients With NMD
Respiratory Muscle Strength and Function in Patients With Neuromuscular Disease
The purpose of this study is to determine if inspiratory muscle strength training (IMST) will impact maximal inspiratory pressure and pulmonary function in patients with neuromuscular disease.
Subjects undergo a 12-week period of inspiratory muscle strength training. Respiratory strength is assessed before and after the training period.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (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
Threshold PEP or IMT device Phillips-Respironics
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 2020
June 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed diagnosis of neuromuscular disease
  • Clinical evidence of impaired pulmonary function

Exclusion Criteria:

  • Above or below age range
  • No clinical evidence of impaired pulmonary function
  • No diagnosis of a neuromusuclar disease
  • Presence of an acute illness at time of study
  • Participating in other research studies involving investigational drugs
  • Diagnosis of a primary pulmonary disease
  • Use of tobacco products
Sexes Eligible for Study: All
6 Months to 65 Years   (Child, Adult)
No
United States
 
 
NCT01555905
UF-IRB 201600270
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
University of Florida
University of Florida
Not Provided
Principal Investigator: Barbara K Smith, PhD, PT University of Florida
University of Florida
October 2017

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