Expiratory Muscle Training for Persons With Neurodegenerative Disease
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Parkinson's Disease, Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT00856518
- Run by
- VA Office of Research and Development
- People needed
- 42
- Starts
- 2009-03-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2017-02-10
Who can join
Age: 35 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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