Expiratory Muscle Training in Patients With Parkinson's Disease

NCT00843739 | Completed Phase 1 DMC

• 1 other identifier: HD046903-01A112
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Breathing; Cough; Speech; Swallow; Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• Maximum Expiratory Pressure

  Four weeks

Secondary Outcomes (4)

• Penetration-Aspiration Score

  Four weeks

• Peak Expiratory Flow Rate

  Four weeks

• Laryngeal Compression Duration

  Four weeks

• Speech timing

  Four weeks

Study Arms (3)

EMST

EXPERIMENTAL

Four week device driven strength training program

Device: EMST - Active Treatment

sham

SHAM COMPARATOR

Four week sham device driven training program

Device: sham EMST

Control

NO INTERVENTION

Four weeks of no intervention

Interventions

EMST - Active Treatment DEVICE

Hand held device used for strengthening expiratory muscles

Also known as: Respiratory Muscle Strength Training

EMST

sham EMST DEVICE

Four week sham device training program

sham

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (7)

• 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.

  PMID: 18728114 BACKGROUND

• 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.

  PMID: 18457885 BACKGROUND

• 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.

  PMID: 17351085 BACKGROUND

• 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.

  PMID: 17294298 BACKGROUND

• 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).

  PMID: 16478374 BACKGROUND

• 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.

  PMID: 16403998 BACKGROUND

• 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.

  PMID: 19029430 RESULT

Related Links

• Movement Disorders Center - Univ of Florida

MeSH Terms

Conditions

Parkinson Disease; Respiratory Aspiration; Cough; Speech

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Verbal Behavior; Communication; Behavior

Study Officials

• Christine M Sapienza, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 13, 2009
• Study Start: January 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2008
• Last Updated: September 20, 2011

Record last verified: 2009-02

Locations

US (1)