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

University of Florida

Status and phase: Completed; Phase 2; Phase 1

Conditions: Parkinson's Disease

Treatments: Device: sham EMST; Device: EMST - Active Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00843739

HD046903-01A112

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

EMST

Experimental group

Description:

Four week device driven strength training program

Treatment:

Device: EMST - Active Treatment

sham

Sham Comparator group

Description:

Four week sham device driven training program

Treatment:

Device: sham EMST

Control

No Intervention group

Description:

Four weeks of no intervention