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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EMST - Active Treatment
sham EMST
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Breathing, Cough, Speech, Swallow, Parkinson's disease

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

EMST

sham

Control

Arm Description

Four week device driven strength training program

Four week sham device driven training program

Four weeks of no intervention

Outcomes

Primary Outcome Measures

Maximum Expiratory Pressure

Secondary Outcome Measures

Penetration-Aspiration Score
Peak Expiratory Flow Rate
Laryngeal Compression Duration
Speech timing

Full Information

First Posted
February 12, 2009
Last Updated
September 16, 2011
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00843739
Brief Title
Expiratory Muscle Training in Patients With Parkinson's Disease
Acronym
EMST
Official Title
Expiratory Muscle Training in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Breathing, Cough, Speech, Swallow, Parkinson's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMST
Arm Type
Experimental
Arm Description
Four week device driven strength training program
Arm Title
sham
Arm Type
Sham Comparator
Arm Description
Four week sham device driven training program
Arm Title
Control
Arm Type
No Intervention
Arm Description
Four weeks of no intervention
Intervention Type
Device
Intervention Name(s)
EMST - Active Treatment
Other Intervention Name(s)
Respiratory Muscle Strength Training
Intervention Description
Hand held device used for strengthening expiratory muscles
Intervention Type
Device
Intervention Name(s)
sham EMST
Intervention Description
Four week sham device training program
Primary Outcome Measure Information:
Title
Maximum Expiratory Pressure
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Penetration-Aspiration Score
Time Frame
Four weeks
Title
Peak Expiratory Flow Rate
Time Frame
Four weeks
Title
Laryngeal Compression Duration
Time Frame
Four weeks
Title
Speech timing
Time Frame
Four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine M Sapienza, Ph.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18728114
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.
Results Reference
background
PubMed Identifier
18457885
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.
Results Reference
background
PubMed Identifier
17351085
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. doi: 10.1177/1545968306294737. Epub 2007 Mar 9.
Results Reference
background
PubMed Identifier
17294298
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. doi: 10.1007/s00455-006-9061-4. Epub 2007 Feb 10.
Results Reference
background
PubMed Identifier
16478374
Citation
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. doi: 10.1044/1092-4388(2005/092).
Results Reference
background
PubMed Identifier
16403998
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.
Results Reference
background
PubMed Identifier
19029430
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):1301-1308. doi: 10.1378/chest.08-1389. Epub 2008 Nov 24.
Results Reference
result
Links:
URL
http://mdc.mbi.ufl.edu
Description
Movement Disorders Center - Univ of Florida

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Expiratory Muscle Training in Patients With Parkinson's Disease

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