Respiratory Muscle Strength in Patients With NMD

NCT ID: NCT01555905

Last Updated: 2023-05-16

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2022-03-31

Brief Summary

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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

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

Conditions

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Neuromuscular Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Exercise

Threshold PEP or IMT device Phillips-Respironics

Group Type EXPERIMENTAL

Threshold PEP or IMT device Phillips-Respironics

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara K Smith, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB201600270

Identifier Type: -

Identifier Source: org_study_id

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