Expiratory Muscle Training for Persons With Neurodegenerative Disease (EMST)

This study has been completed.
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00856518
First received: March 3, 2009
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

Respiratory difficulty is one of the primary factors leading to death in patients with Parkinson's Disease (PD) and Multiple Sclerosis. Both diseases are progressive degenerating diseases that cause difficulties in breathing, airway protection and swallowing. Patients with PD and MS typically become sedentary and lose endurance, maximal fitness levels and overall pulmonary function. Much of the research focus has been on the motor symptoms of PD and MS yet the pulmonary and swallowing complications are perhaps ultimately the most important disability as the diseases progress. The inability to generate adequate respiratory pressure is responsible for reduced cough magnitudes and cough response times. Cough is critical for the clearance of foreign materials in the airway helping to reduce infiltration of bacteria and subsequent respiratory infection. With reduced cough function an increased risk for pulmonary disease occurs due to a reduced ability to protect the airways. There are a number of promising outcomes from an expiratory strength-training program. By increasing expiratory muscle strength and expiratory pressure generation, effective breathing, clearance of the airway, and improved swallowing can occur. These explicit outcomes are predicted based on our experience with the use of an innovative device-driven, home-based expiratory strength training program focused on the expiratory muscles of respiration. This project focuses on following patients with PD and MS for an initial 5 weeks of strength training and them testing the outcome of a caregiver program for maintaining treatment effects.


Condition Intervention Phase
Parkinson's Disease
Multiple Sclerosis
Device: Expiratory Muscle Strength Trainer
Device: sham device
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Expiratory Muscle Training for Persons With Neurodegenerative Disease

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Penetration-Aspiration Scale Score [ Time Frame: Study completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2009
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Experimental Group
Device: Expiratory Muscle Strength Trainer
Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles.
Other Name: EMST
Sham Comparator: Arm 2
sham group
Device: sham device
Looks just like the EMST device but does not provide a load on the target muscle group

Detailed Description:

The proposed investigation will:

Determine if 5 weeks of Expiratory Muscle Strength Training (EMST) increases maximal expiratory driving pressure (MEP) and improves swallow, cough and breathing function in individuals with PD and MS. Following the post assessment of the 5 week EMST program we will then evaluate three different modules for monitoring the continuation of the treatment while assessing patient quality of life and caregiver burden/satisfaction. This will help us determine if one particular home training method results in different physiological and functional outcomes.

Aim 1. Determine the effects of an EMST program on swallow function, voluntary cough production and breathing function in individuals with PD and MS identified as below normal limits for their age and sex (via physiological measures).

Hypothesis 1: There will significant and positive treatment effects following 5 weeks of EMST on the measures of swallow, cough production and breathing function in those with PD and MS following 5 weeks of treatment.

Aim 2: Determine the outcome of three uniquely structured home treatment monitoring programs in maintaining the EMST post treatment effect for patients with MS and PD. These programs are referred to as: Education Module (A), Question Only (B), and Education Module plus Question (C). The monitoring system will be provided by VitelNet, a leading provider of home health monitoring, clinician-based telemedicine Hypothesis 2: Program C will provide greater maintenance of the EMST treatment effect for both patient groups compared to programs A and B.

Aim 3: Determine the effects of the home monitoring programs for improving patient quality of life and caregiver burden/satisfaction.

Hypothesis 3: Program C will provide greater improvements in patient quality of life and caregiver burden compared to programs A and B.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Multiple Sclerosis Participants

  • Diagnosis of primary, secondary, or relapsing-remitting MS by a neurologist. Over 85% of the patient populations that come from the study sites demonstrate relapsing-remitting MS with an average relapse frequency of once every 3 years.

Parkinson's Disease Participants

  • Hoehn & Yahr, stage II and III as indicated by certified movement disorders neurologist

All Participants

  • Between 35 and 80 years of age
  • Non-smoking or no smoking within the previous five years
  • No history of head and neck cancer, asthma or COPD, untreated hypertension
  • Sufficient facial muscle strength so as to achieve and maintain adequate lip closure around a circular mouthpiece
  • Cognition within normal limits as determined by the: Mini Mental Status Exam (MMSE; 1975No neurological (other than MS or PD) condition which adversely affects respiratory muscle or gas exchange system
  • Reduced MEP's compared to published normative data for age and sex
  • Reduced expiratory peak flow rates (6-8 L/s for young to middle age adults and 3.6 L/s for 65 and older) during voluntary cough production for age and sex (Bolser, personal communication; Smith-Hammond & Goldstein, 2006)
  • Participant report of symptoms related to swallow impairment

Exclusion Criteria:

DBS COPD Asthma Smoking or smoking within preceding 5 years

  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: NCT00856518

Locations
United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Janis Daly, PhD MS North Florida/South Georgia Veterans Health System, Gainesville, FL
  More Information

Additional Information:
No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00856518     History of Changes
Other Study ID Numbers: B6576-R
Study First Received: March 3, 2009
Last Updated: August 14, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Multiple Sclerosis
Parkinson's disease
Dysphagia

Additional relevant MeSH terms:
Sclerosis
Parkinson Disease
Multiple Sclerosis
Neurodegenerative Diseases
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014