Respiratory Muscle Strength in Patients With NMD

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Florida
Sponsor:
Collaborator:
Acid Maltase Deficiency Association
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01555905
First received: March 14, 2012
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

Inspiratory Muscle strength training (IMST) will significantly improve maximal inspiratory pressure and pulmonary function in patients with neuromuscular disease and respiratory muscle contractile dysfunction.


Condition Intervention Phase
Neuromuscular Disease
Device: Threshold PEP or IMT device Phillips-Respironics
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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:
  • VT/FVC [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The primary endpoints for inspiratory muscle training efficacy will include respiratory muscle strength.


Secondary Outcome Measures:
  • VT/FVC [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Secondary outcome measures include respiratory function and breathing pattern during loaded breathing


Estimated Enrollment: 30
Study Start Date: April 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise 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.

  Eligibility

Ages Eligible for Study:   12 Months to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neuromuscular Disease

Exclusion Criteria:

  • Above or below age range.
  • No acute illness at time of study.
  • Use of tobacco products.
  • FVC within normal limits.
  • No evidence of Neuromuscular Disease.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: LeeAnn Lawson, MSN    352-273-7762    llawson@peds.ufl.edu   
Principal Investigator: Barbara K Smith, PhD, PT         
Sponsors and Collaborators
University of Florida
Acid Maltase Deficiency Association
Investigators
Principal Investigator: Barbara K Smith, PhD, PT University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01555905     History of Changes
Other Study ID Numbers: UF-IRB 147-2011
Study First Received: March 14, 2012
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Florida:
Respiratory Muscle Strength

Additional relevant MeSH terms:
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 21, 2014