Respiratory Muscle Strength in Patients With NMD

NCT01555905 | Terminated Results FDA Device

• 1 other identifier: IRB201600270
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Disease

Keywords

Respiratory Muscle Strength

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Exercise

EXPERIMENTAL

Threshold PEP or IMT device Phillips-Respironics

Device: Threshold PEP or IMT device Phillips-Respironics

Interventions

Threshold PEP or IMT device Phillips-Respironics DEVICE

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.

Exercise

Eligibility Criteria

• Age: 6 Months - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of neuromuscular disease
• Clinical evidence of impaired pulmonary function

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Limitations and Caveats

Study termination due to low proportion of subjects who completed the intervention and returned to the study center for post-testing.

Results Point of Contact

• Title: D. Barbara Smith
• Organization: University of Florida

bksmith@ufl.edu

3522945315

Study Officials

• Barbara K Smith, PhD, PT

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 16, 2012
• Study Start: April 1, 2011
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 16, 2023
• Results First Posted: May 16, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)