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Respiratory Muscle Strength in Patients With NMD (RMST)

This study is currently recruiting participants.
Verified October 2017 by University of Florida
Sponsor:
ClinicalTrials.gov Identifier:
NCT01555905
First Posted: March 16, 2012
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
  Purpose
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.

Condition Intervention
Neuromuscular Disease Device: Threshold PEP or IMT device Phillips-Respironics

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Respiratory Muscle Strength and Function in Patients With Neuromuscular Disease

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Maximal respiratory pressure [ Time Frame: 3 months ]
    The primary endpoints for inspiratory muscle training efficacy will be maximal respiratory pressure tests, a measure of respiratory strength.


Secondary Outcome Measures:
  • Peak flow volumes during loaded breaths [ Time Frame: 3 months ]
    Secondary outcome measures include respiratory function and breathing pattern during loaded breathing against standard resistances.


Estimated Enrollment: 30
Study Start Date: April 2011
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555905


Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Barbara K Smith, PhD, PT    352-294-5315    bksmith@phhp.ufl.edu   
Contact: Lee Kugelmann    352-273-6855    ekugelm@ufl.edu   
Principal Investigator: Barbara K Smith, PhD, PT         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Barbara K Smith, PhD, PT University of Florida
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01555905     History of Changes
Other Study ID Numbers: UF-IRB 201600270
First Submitted: March 14, 2012
First Posted: March 16, 2012
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Respiratory Muscle Strength

Additional relevant MeSH terms:
Neuromuscular Diseases
Nervous System Diseases