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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00843739
First received: February 12, 2009
Last updated: September 16, 2011
Last verified: February 2009
  Purpose

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 Intervention Phase
Parkinson's Disease
Device: EMST - Active Treatment
Device: sham EMST
Phase 1
Phase 2

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 in Patients With Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Maximum Expiratory Pressure [ Time Frame: Four weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Penetration-Aspiration Score [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
  • Peak Expiratory Flow Rate [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
  • Laryngeal Compression Duration [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
  • Speech timing [ Time Frame: Four weeks ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: January 2004
Study Completion Date: December 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00843739

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

Additional Information:
Publications:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00843739     History of Changes
Other Study ID Numbers: HD046903-01A112, HD046903-01A112
Study First Received: February 12, 2009
Last Updated: September 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Breathing
Cough
Speech
Swallow
Parkinson's disease

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

ClinicalTrials.gov processed this record on November 27, 2014