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Trial record 1 of 87 for:    Respiratory strength neuromuscular disease
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Respiratory Muscle Strength in Patients With NMD (RMST)

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ClinicalTrials.gov Identifier: NCT01555905
Recruitment Status : Recruiting
First Posted : March 16, 2012
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neuromuscular Disease Device: Threshold PEP or IMT device Phillips-Respironics Not Applicable

Detailed Description:
Subjects undergo a 12-week period of inspiratory muscle strength training. Respiratory strength is assessed before and after the training period.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Respiratory Muscle Strength and Function in Patients With Neuromuscular Disease
Study Start Date : April 2011
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Exercise
Threshold PEP or IMT device Phillips-Respironics
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555905


Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Barbara K Smith, PhD, PT    352-294-5315    bksmith@phhp.ufl.edu   
Contact: Lee Kugelmann    352-273-6855    ekugelm@ufl.edu   
Principal Investigator: Barbara K Smith, PhD, PT         
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Barbara K Smith, PhD, PT University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01555905    
Other Study ID Numbers: UF-IRB 201600270
First Posted: March 16, 2012    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Florida:
Respiratory Muscle Strength
Additional relevant MeSH terms:
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Neuromuscular Diseases
Nervous System Diseases