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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 April 2022
Main ID:  NCT01555905
Date of registration: 14/03/2012
Prospective Registration: No
Primary sponsor: University of Florida
Public title: Respiratory Muscle Strength in Patients With NMD RMST
Scientific title: Respiratory Muscle Strength and Function in Patients With Neuromuscular Disease
Date of first enrolment: April 2011
Target sample size: 17
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01555905
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Barbara K Smith, PhD, PT
Address: 
Telephone:
Email:
Affiliation:  University of Florida
Key inclusion & exclusion 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



Age minimum: 6 Months
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Neuromuscular Disease
Intervention(s)
Device: Threshold PEP or IMT device Phillips-Respironics
Primary Outcome(s)
Maximal respiratory pressure [Time Frame: 3 months]
Secondary Outcome(s)
Peak flow volumes during loaded breaths [Time Frame: 3 months]
Secondary ID(s)
IRB201600270
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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