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Respiratory Muscle Strength in Patients With NMD (RMST)

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01555905
First received: March 14, 2012
Last updated: April 4, 2017
Last verified: April 2017
  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

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
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: 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
Study First Received: March 14, 2012
Last Updated: April 4, 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

ClinicalTrials.gov processed this record on September 21, 2017