Expiratory Muscle Training in Patients With Parkinson's Disease (EMST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00843739
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : September 20, 2011
Information provided by (Responsible Party):
University of Florida

Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: EMST - Active Treatment Device: sham EMST Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Expiratory Muscle Training in Patients With Parkinson's Disease
Study Start Date : January 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: EMST
Four week device driven strength training program
Device: EMST - Active Treatment
Hand held device used for strengthening expiratory muscles
Other Name: Respiratory Muscle Strength Training
Sham Comparator: sham
Four week sham device driven training program
Device: sham EMST
Four week sham device training program
No Intervention: Control
Four weeks of no intervention

Primary Outcome Measures :
  1. Maximum Expiratory Pressure [ Time Frame: Four weeks ]

Secondary Outcome Measures :
  1. Penetration-Aspiration Score [ Time Frame: Four weeks ]
  2. Peak Expiratory Flow Rate [ Time Frame: Four weeks ]
  3. Laryngeal Compression Duration [ Time Frame: Four weeks ]
  4. Speech timing [ Time Frame: Four weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00843739

United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Principal Investigator: Christine M Sapienza, Ph.D. University of Florida

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: University of Florida Identifier: NCT00843739     History of Changes
Other Study ID Numbers: HD046903-01A112
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: September 20, 2011
Last Verified: February 2009

Keywords provided by University of Florida:
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases