Respiratory Muscle Strength in Patients With NMD (RMST)

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.

Study Overview

• Status: Terminated
• Conditions: Neuromuscular Disease
• Intervention / Treatment: Device: Threshold PEP or IMT device Phillips-Respironics

Detailed Description

Subjects undergo a 12-week period of inspiratory muscle strength training. Respiratory strength is assessed before and after the training period.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal Inspiratory Pressure	The primary endpoints for inspiratory muscle training efficacy will be maximal inspiratory pressure tests, a measure of respiratory strength.	Baseline (pre-IMST) and 3 months (post-IMST)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak flow volumes during loaded breaths	Secondary outcome measures include respiratory function and breathing pattern during loaded breathing against standard resistances.	3 months

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Barbara K Smith, PhD, PT, University of Florida

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: March 14, 2012
• First Submitted That Met QC Criteria: March 15, 2012
• First Posted (Estimate): March 16, 2012

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Respiratory Muscle Strength
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: IRB201600270

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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