Dysphagia, Dystussia, Parkinson's Disease
Conditions
Keywords
Rehabilitation, Parkinson's disease, Swallowing, Cough, Dysphagia, Dystussia
Brief summary
Currently, there are no efficacious behavioral treatment approaches to address uncompensated aspiration, or aspiration without appropriate cough response, in Parkinson's disease (PD). This is of particular public health concern given that aspiration pneumonia is the leading cause of death in persons with PD. The overarching aim of the proposed study is to determine the efficacy of two distinct intensive rehabilitation paradigms, expiratory muscle strength training (EMST) and sensorimotor treatment for airway protection (smTAP), on airway protective clinical outcomes in persons with PD and dysphagia. The investigators anticipate the results will lead to reductions in the risks associated with airway protective deficits.
Detailed description
Study Rationale: Aspiration pneumonia is a leading cause of death in persons with Parkinson's disease (PD). One of the main reasons people with PD develop aspiration pneumonia is that they often have both swallowing dysfunction (dysphagia) and cough dysfunction (dystussia). Because of this, if food or liquid enters the airway, a cough is not elicited and the material remains in the airway (silent aspiration). It is then possible for the material to enter the lungs resulting in an infection called aspiration pneumonia. Currently, there are no tested treatment approaches that specifically target silent aspiration. Hypothesis: The goal of this study is to determine how well two different rehabilitation treatments, expiratory muscle strength training (EMST) and sensorimotor treatment for airway protection (smTAP), work to improve cough and swallowing function in persons with PD and dysphagia. Study Design: This study will include two participant groups; one group will receive EMST and the other will receive smTAP. There will be initial baseline testing of swallowing, coughing, respiratory, and laryngeal function. The investigators will also measure the participants' perception of their cough and swallowing problem. Then, participants will be randomly assigned (much like the flip of a coin) to either the EMST or smTAP training groups. The participants will be further randomized to receive immediate training or delayed training where there is a 5-week wait to start with a second baseline performed at the end of the 5-week delay. Once training is complete the participants will once again complete measures of swallowing, coughing, respiratory and laryngeal function. Impact on Diagnosis/Treatment of Parkinson's Disease: The investigators anticipate that this study will assist in better understanding what treatments work best to improve swallowing and cough in people with PD; resulting in an immediate shift in the clinical management of swallowing and cough dysfunction in PD. The investigators also believe that participants will have improvements in swallowing and cough function; therefore, reducing the risk of aspiration pneumonia.
Interventions
DEVICEEMST
BEHAVIORALsmTAP
Sponsors
Michael J. Fox Foundation for Parkinson's Research
University of Florida
Teachers College, Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with PD (Hoehn and Yahr Stages II-IV) 2. Difficulty swallowing 3. Not actively receiving swallowing therapy.
Exclusion criteria
1. Other neurological disorders (e.g., multiple sclerosis, stroke, etc.) 2. History of head and neck cancer 3. History of breathing disorders or diseases (e.g., COPD) 4. History of smoking in the last five years 5. Uncontrolled hypertension 6. Difficulty complying due to neuropsychological dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Voluntary Cough Peak Flow | Pre to Post treatment (Pre: Baseline and Post Treatment: 5 weeks) | Peak expiratory flow rate (PEFR) was measured before (baseline) and after 5 weeks of treatment with EMST and smTAP. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Expiratory Muscle Strength Training (EMST) Participants will receive Expiratory Muscle Strength Training (EMST) | 34 |
| Sensorimotor Training for Airway Protection (smTAP) Participants will receive Sensorimotor training for airway protection (smTAP) | 31 |
| Total | 65 |
Baseline characteristics
| Characteristic | Sensorimotor Training for Airway Protection (smTAP) | Expiratory Muscle Strength Training (EMST) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 25 Participants | 47 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants | 18 Participants |
| Age, Continuous | 69.1 years | 70.5 years | 70 years |
| Maximum Expiratory Pressure | 112 cm H20 | 97 cm H20 | 102 cm H20 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 31 participants | 34 participants | 65 participants |
| Sex: Female, Male Female | 9 Participants | 13 Participants | 22 Participants |
| Sex: Female, Male Male | 22 Participants | 21 Participants | 43 Participants |
| Voluntary Cough Peak Flow | 3.05 l/s | 2.98 l/s | 3.04 l/s |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 31 |
| other Total, other adverse events | 0 / 34 | 0 / 31 |
| serious Total, serious adverse events | 0 / 34 | 0 / 31 |
Outcome results
Primary
Change in Voluntary Cough Peak Flow
Peak expiratory flow rate (PEFR) was measured before (baseline) and after 5 weeks of treatment with EMST and smTAP.
Time frame: Pre to Post treatment (Pre: Baseline and Post Treatment: 5 weeks)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| EMST | Change in Voluntary Cough Peak Flow | 0.17 l/s |
| smTAP | Change in Voluntary Cough Peak Flow | 0.51 l/s |