Expiratory Muscle Training for Persons With Neurodegenerative Disease

NCT00856518 | Completed Phase 2 Results

• 1 other identifier: B6576-R
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease; Multiple Sclerosis

Keywords

Multiple Sclerosis; Parkinson's disease; Dysphagia

Outcome Measures

Primary Outcomes (3)

• Maximum Expiratory Pressure (MEP)

  Expiratory pressure generating capacity assessed via handheld manometer.

  at baseline and again after 5-week EMST exercise

• Penetration-Aspiration Scale Score

  The Penetration-Aspiration Scale (PAS) was used to measure swallow safety. PAS is an 8 point ordinal scale for quantification of penetration and aspiration. PAS measures the depth to which material enters the airway and if the material is expelled following penetration or aspiration. Categorical groupings of PAS scores include "normal to mild" (1-2), "moderate" (3-5) and "severe" (6-8, indicating that material has passed into the lower airway). These PAS scores may be useful in denoting clinically significant changes (e.g. moderate to mild) resulting from treatment or disease progression. The following table reports the percentage of participants (out of the respective total group participants in EMST and Sham) with changed PAS score of 1 point or more (improving or worsening) and without PAS score changes from pre- to post treatment. The data represent an exploratory quantification without statistical analysis.

  at baseline and again after 5-week EMST exercise

• Swallow-related Quality of Life (SWAL-QOL)

  The SWAL-QOL is a validated and standardized tool that measures burden; symptom status including pharyngeal, oral, and saliva; fear; and mental health subdomains. Responses are determined according to an ordinal scale where 1 equals a severe problem and 5 equals no problem. The SWAL-QOL provides an overall score as well as subscale scores. Subjects rate quality of life as follows (expressed as percentage of the possible perfect score): little to no impact (81% - 100%), mild impact (61% - 80%), moderate impact (41% - 60%), severe impact (21% - 40%), and profound impact (0% - 20%).

  at baseline and after 5-week of EMST exercise

Study Arms (2)

Arm 1: EMST

ACTIVE COMPARATOR

The experimental group receives five weeks of expiratory muscle strength training (EMST) using a positive pressure threshold device

Device: EMST

Arm 2: Sham group

SHAM COMPARATOR

The Sham group undergoes the same 5-week EMST exercise as the experimental group using the same device but without a spring for minimal pressure load

Device: Sham

Interventions

EMST DEVICE

Pressure threshold device (Expiratory Muscle Strength Trainer) targeted at increase muscle force generation of expiratory and submental muscles.

Also known as: EMST 150

Arm 1: EMST

Sham DEVICE

The same device just like the EMST but does not provide a load on the target muscle group

Arm 2: Sham group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• DBS
• COPD
• Asthma
• Smoking or smoking within preceding 5 years

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Florida: collaborator

Study Sites (1)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Multiple Sclerosis; Deglutition Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Dr. Janis Daly
• Organization: North Florida/South Georgia Veterans Health System

janis.daly@neurology.ufl.edu

352-376-1611

Study Officials

• Janis J. Daly, PhD MS

  North Florida/South Georgia Veterans Health System, Gainesville, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: March 5, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 10, 2017
• Results First Posted: November 29, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)