Respiratory Muscle Strength in Patients With NMD

Neuromuscular Disease Clinical Trial

— RMST  

Official title:

Respiratory Muscle Strength and Function in Patients With Neuromuscular Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01555905
• Other study ID #: IRB201600270
• Status: Terminated
• Phase: N/A
• Start date: April 2011
• Est. completion date: March 2022

Study information

• Verified date: April 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Disease
• Neuromuscular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)