Back to resultsRespiratory Muscle Strength in Patients With NMD (RMST)
Primary Purpose
Neuromuscular Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Threshold PEP or IMT device Phillips-Respironics
Sponsored by
About this trial
This is an interventional prevention trial for Neuromuscular Disease focused on measuring Respiratory Muscle Strength
Eligibility 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
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise
Arm Description
Threshold PEP or IMT device Phillips-Respironics
Outcomes
Primary Outcome Measures
Maximal Inspiratory Pressure
The primary endpoints for inspiratory muscle training efficacy will be maximal inspiratory pressure tests, a measure of respiratory strength.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01555905
Brief Title
Respiratory Muscle Strength in Patients With NMD
Acronym
RMST
Official Title
Respiratory Muscle Strength and Function in Patients With Neuromuscular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2022 (Actual)
Study Completion Date
March 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Subjects undergo a 12-week period of inspiratory muscle strength training. Respiratory strength is assessed before and after the training period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Disease
Keywords
Respiratory Muscle Strength
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Threshold PEP or IMT device Phillips-Respironics
Intervention Type
Device
Intervention Name(s)
Threshold PEP or IMT device Phillips-Respironics
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximal Inspiratory Pressure
Description
The primary endpoints for inspiratory muscle training efficacy will be maximal inspiratory pressure tests, a measure of respiratory strength.
Time Frame
Baseline (pre-IMST) and 3 months (post-IMST)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara K Smith, PhD, PT
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Respiratory Muscle Strength in Patients With NMD
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