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Parkinson's DiseasePhase 1/2EMSTNCT00843739

Expiratory Muscle Training in Patients With Parkinson's Disease

A Phase 1/2 study testing EMST - Active Treatment in people with Parkinson's Disease, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 35 to 85 years
Conditions the study is for
Parkinson's Disease
What is being tested?
EMST - Active Treatment
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteUnited States
Study dates
Jan 2004to Dec 2008
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)).
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Florida

    Gainesville, Florida, 32611

Other trials in United States

About this study

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.

Being tested
EMST - Active Treatment, sham EMST
Keywords
Breathing, Cough, Speech, Swallow, Parkinson's disease
Medical subject headings
Parkinson Disease, Respiratory Aspiration, Cough, Speech

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EMST - Active TreatmentDevice

    Also called Respiratory Muscle Strength Training

    Hand held device used for strengthening expiratory muscles

  • sham EMSTDevice

    Four week sham device training program

Study groups in NCT00843739
Study groupRoleWhat they receive
EMSTExperimentalFour week device driven strength training program
Receives: Device: EMST - Active Treatment
shamSham comparatorFour week sham device driven training program
Receives: Device: sham EMST
ControlNo interventionFour weeks of no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Expiratory Pressure

    Measured: Four weeks

Secondary outcomes (4)

  1. Penetration-Aspiration Score

    Measured: Four weeks

  2. Peak Expiratory Flow Rate

    Measured: Four weeks

  3. Laryngeal Compression Duration

    Measured: Four weeks

  4. Speech timing

    Measured: Four weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2009 (estimated)
  2. Study startJan 2004
  3. Primary completionDec 2007
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00843739
Sponsor's protocol ID
HD046903-01A112
Other IDs
HD046903-01A112
Acronym
EMST
Status last verified
Feb 2009
First submitted
12 Feb 2009
Last updated
20 Sep 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18728114

  • 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.

    PubMed 18457885

  • 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.

    PubMed 17351085

  • 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.

    PubMed 17294298

  • 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).

    PubMed 16478374

  • 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.

    PubMed 16403998

  • 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.

    PubMed 19029430

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EMST - Active Treatment in people with Parkinson's Disease, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Expiratory Pressure (time frame: Four weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00843739, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2011.

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