Expiratory Muscle Training in Patients With Parkinson's Disease

Parkinson's Disease Clinical Trial

— EMST  

Official title:

Expiratory Muscle Training in Patients With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843739
• Other study ID #: HD046903-01A112
• Secondary ID: HD046903-01A112
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 12, 2009
• Last updated: September 16, 2011
• Start date: January 2004
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Respiratory difficulty is one of the primary factors leading to death in patients with Idiopathic Parkinson's Disease (IPD). The progressive degeneration of a family of segregated motor and non-motor circuits in the brain results in motor and non-motor dysfunction. Breathing and swallowing are well known to be affected in IPD, and attention to these functions is fitting since most patients eventually experience morbidity and even mortality as a result of this dysfunction. Patients with IPD 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 IPD (tremor, rigidity, bradykinesia) yet the pulmonary complications are perhaps ultimately the most important disability. 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 due to a reduced ability to protect the airways occurs. Moreover, the recognized debilitating disruptions to voice and speech characteristics that limit communication, care taking, employment opportunities and social interactions are also a result of poor respiratory function. 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, production of a louder and clearer voice as well as 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.

The aims of this study are to: 1) Investigate the activity of expiratory muscle strength training (EMT) in patients with idiopathic Parkinson's disease (IPD), 2) Determine the effect of increased expiratory force generation on breathing, cough magnitude, speech production, and swallowing, 3) Determine the effect of increased expiratory force generation on the patient's perception of speech change, 4) Determine the effect of Dopamine-replacement therapy (Parkinson's medications) on breathing, coughing, speaking, and swallowing measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 85 Years

Eligibility

Inclusion Criteria:

• Adults between the age of 35 and 85 years.

• Diagnosis of Idiopathic Parkinson's Disease (either tremor-predominant or rigid- predominant) by their neurologist.

• Disability level of II, III, or IV (Hoehn & Yahr, 1976) as indicated in their most recent neurological evaluation.

• Forced Expiratory Volumes (FEV1) and forced vital capacity (FVC) within normative range for age and sex determined by a pulmonary function screening.

• Persons who are able to maintain their current level of physical activity (including both aerobic exercise and weightlifting) throughout the entire training period.

*Subjects will be asked to report any significant changes in their level of activity throughout their participation in the study in regards to intensity and frequency of exercise (i.e. a sedentary person begins exercising three to four days per week).

• Completion of the informed consent to participate in the study.

Exclusion Criteria:

• Other neurological disorders

• Positive history of any of the following conditions:

• Gastrointestinal disease

• Gastro-esophageal surgery

• Head or neck cancer

• History of breathing disorders or diseases (e.g., Asthma, chronic obstructive pulmonary disease (COPD)).

• Untreated hypertension

• Heart disease

• History of smoking in the last five years

• Failing the screening test of pulmonary functions (e.g., FEV1/FVC < 75%)

• Difficulty in complying with the training protocol due to neuropsychological dysfunction (e.g., severe depression).

• Other illness that would prevent patient from completing the protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• EMST - Active Treatment
Hand held device used for strengthening expiratory muscles
• sham EMST
Four week sham device training program

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (7)

Baker S, Davenport P, Sapienza C. Examination of strength training and detraining effects in expiratory muscles. J Speech Lang Hear Res. 2005 Dec;48(6):1325-33. — View Citation

Chiara T, Martin D, Sapienza C. Expiratory muscle strength training: speech production outcomes in patients with multiple sclerosis. Neurorehabil Neural Repair. 2007 May-Jun;21(3):239-49. Epub 2007 Mar 9. — View Citation

Kim J, Davenport P, Sapienza C. Effect of expiratory muscle strength training on elderly cough function. Arch Gerontol Geriatr. 2009 May-Jun;48(3):361-6. doi: 10.1016/j.archger.2008.03.006. Epub 2008 May 23. — View Citation

Pitts T, Bolser D, Rosenbek J, Troche M, Okun MS, Sapienza C. Impact of expiratory muscle strength training on voluntary cough and swallow function in Parkinson disease. Chest. 2009 May;135(5):1301-8. doi: 10.1378/chest.08-1389. Epub 2008 Nov 24. — View Citation

Saleem AF, Sapienza CM, Okun MS. Respiratory muscle strength training: treatment and response duration in a patient with early idiopathic Parkinson's disease. NeuroRehabilitation. 2005;20(4):323-33. — View Citation

Wheeler KM, Chiara T, Sapienza CM. Surface electromyographic activity of the submental muscles during swallow and expiratory pressure threshold training tasks. Dysphagia. 2007 Apr;22(2):108-16. Epub 2007 Feb 10. — View Citation

Wheeler-Hegland KM, Rosenbek JC, Sapienza CM. Submental sEMG and hyoid movement during Mendelsohn maneuver, effortful swallow, and expiratory muscle strength training. J Speech Lang Hear Res. 2008 Oct;51(5):1072-87. doi: 10.1044/1092-4388(2008/07-0016). Epub 2008 Aug 26. Erratum in: J Speech Lang Hear Res. 2008 Dec;51(6):1643. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Expiratory Pressure		Four weeks	No
Secondary	Penetration-Aspiration Score		Four weeks	No
Secondary	Peak Expiratory Flow Rate		Four weeks	No
Secondary	Laryngeal Compression Duration		Four weeks	No
Secondary	Speech timing		Four weeks	No

External Links

•   Department of Communication Sciences and Disorders - UF
•   Movement Disorders Center - Univ of Florida