Airway Protection Rehabilitation for Parkinson's Disease

Recruiting at 1 trial location

Overseen By Michelle Troche, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Teachers College, Columbia University

Disqualifiers: Other neurological disorders, Breathing disorders, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to assist people with Parkinson's Disease (PD) who struggle to protect their airways, potentially leading to serious lung issues. The study will test a new treatment involving Expiratory Muscle Strength Training (EMST) and Cough Skill Training, which are breathing and coughing exercises, delivered either in-person or through telehealth. It seeks participants with PD who have swallowing or coughing difficulties and are not currently receiving exercise-based therapy for swallowing. Participants must live within 1.5 hours of the study locations and meet other specific health criteria. This research aims to make effective treatments more accessible to people with PD. As a Phase 2 trial, it focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in PD care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Expiratory Muscle Strength Training (EMST) combined with Cough Skill Training is safe for people with Parkinson's Disease. These treatments improve airway protection without major side effects.

One study found that participants increased their ability to exhale forcefully by 19% after using EMST. This improvement, known as Maximum Expiratory Pressure (MEP), indicates that the treatment is effective and well-tolerated. No serious side effects related to the treatment were reported.

Overall, these findings suggest that this treatment approach is safe for those with Parkinson's Disease. It focuses on strengthening the muscles used for breathing and coughing, which can help prevent issues like aspiration pneumonia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for Parkinson's disease because they focus on enhancing airway protection, which is a critical issue for many patients. Unlike standard treatments that mainly address motor symptoms, Expiratory Muscle Strength Training coupled with Cough Skill Training targets the muscles involved in breathing and coughing. This approach not only aims to improve respiratory function but also offers the convenience of being delivered in-person or via telehealth, making it accessible to more patients. By strengthening the muscles involved in expiration and coughing, these methods have the potential to significantly reduce the risk of aspiration and related complications.

What evidence suggests that this trial's treatments could be effective for airway protection in Parkinson's Disease?

Research has shown that Expiratory Muscle Strength Training (EMST) can greatly improve breathing and swallowing for people with Parkinson's Disease. Studies have found that EMST strengthens and enhances coughing, which helps protect the airway. This is crucial because problems with airway protection can lead to serious issues like pneumonia, a leading cause of death in people with Parkinson's. In this trial, participants will receive either in-person or telehealth delivery of the combined EMST and Cough Skill Training. Combining EMST with Cough Skill Training might enhance these benefits by teaching patients how to clear their airways better. Early research suggests this combined approach is a promising way to manage airway protection problems in Parkinson's Disease. ^{2 6 7 8 9}

Who Is on the Research Team?

Michelle Troche, PhD

Principal Investigator

Teachers College, Columbia University

Are You a Good Fit for This Trial?

This trial is for people aged 50-90 with Parkinson's Disease who have trouble swallowing or coughing but aren't currently getting therapy for it. They must be diagnosed by a specialist and can't have other neurological disorders, recent smoking history, breathing diseases, severe depression or dementia.

Inclusion Criteria

I have trouble swallowing thin liquids or coughing effectively.

I have Parkinson's disease, stages II-IV, confirmed by a specialist.

I am not currently undergoing any exercise-based therapy for swallowing.

Exclusion Criteria

I have had head or neck cancer in the past.

My blood pressure is not well-controlled.

I have a history of lung problems like COPD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intensive Treatment

Participants undergo four weeks of intensive Expiratory Muscle Strength Training (EMST) and Cough Skill Training (CST) delivered in-person or via telehealth

4 weeks

4 visits (in-person or virtual)

Maintenance Treatment

Participants continue with a long-term EMST+CST maintenance program offered in-person or via telehealth

1 year

Assessments at 6 and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Expiratory Muscle Strength Training + Cough Skill Training

Trial Overview

The study tests whether training to strengthen the muscles used in breathing out and coughing helps protect the airway better than usual care. It compares results of doing these exercises in-person versus via telehealth to see which is more effective.

How Is the Trial Designed?

Group I: Telehealth Experimental Treatment 1 Intervention

Group II: In-person Active Control 1 Intervention

Who Is Running the Clinical Trial?

Teachers College, Columbia University

Lead Sponsor

Trials

27

Recruited

6,100+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Purdue University

Collaborator

Trials

239

Recruited

72,200+

Published Research Related to This Trial

In a study involving 56 participants with Parkinson's Disease, neither expiratory muscle strength training (EMST) nor sensorimotor training of airway protection (smTAP) showed significant changes in vocal fold bowing or the presence of vocal fold lesions, indicating that these treatments do not negatively impact vocal fold health.

Both EMST and smTAP were found to be safe interventions, as they did not lead to the development of vocal fold lesions despite involving forceful exhalation and repetitive coughing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cough and Swallowing Therapy and Their Effects on Vocal Fold Bowing and Laryngeal Lesions. Doruk, C., Curtis, JA., Dakin, AE., et al.[2023]

In a study involving 33 participants with Parkinson's disease, the combination of expiratory muscle training (EMT) and air stacking (AS) significantly improved both voluntary and reflex peak cough flow (PCF) compared to EMT alone.

The EMT plus AS group showed a greater enhancement in reflex PCF, indicating that this combined approach may be more effective for improving cough strength in individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Expiratory Muscle Training and Air Stacking on Peak Cough Flow in Individuals with Parkinson's Disease. Reyes, A., Castillo, A., Castillo, J.[2021]

Expiratory muscle strength training (EMST) is feasible and safe for individuals who have undergone total laryngectomy, with high compliance observed among participants in the study.

While EMST led to improvements in maximum expiratory pressure and vocal loudness, it did not result in significant changes in other pulmonary function or patient-reported outcomes, suggesting further research is needed in a larger group with more pronounced pulmonary issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expiratory Muscle Strength Training in patients After Total Laryngectomy; A Feasibility Pilot Study. van Sluis, KE., Kornman, AF., Groen, WG., et al.[2022]

After 3 months of expiratory muscle strength training (EMST), participants with Parkinson's disease showed a 19% improvement in maximum expiratory pressure (MEP), indicating that EMST is effective for enhancing respiratory function.

Following a 3-month detraining period, MEP slightly declined by 2% but remained 17% above baseline levels, suggesting that while some benefits of EMST are retained, maintenance programs may be necessary to sustain improvements in muscle strength and swallowing safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detraining outcomes with expiratory muscle strength training in Parkinson disease. Troche, MS., Rosenbek, JC., Okun, MS., et al.[2021]

The study demonstrated that both Expiratory Muscle Strength Training (EMST) and Cough Skill Training (CST) can be effectively delivered via telehealth, with participants completing treatments in about 17.5 minutes per session.

Participants showed significant improvements in airway protection measures, specifically maximum expiratory pressure (pMEP) and peak expiratory flow rate (PEFR), indicating that telehealth can enhance access to important therapies for individuals with neurodegenerative movement disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation of Airway Protection in Individuals With Movement Disorders: A Telehealth Feasibility Study. Sevitz, JS., Borders, JC., Dakin, AE., et al.[2023]

Expiratory muscle strength training (EMST) using a pressure threshold device shows promising benefits for respiratory function, including improvements in speech, swallowing, voice, and cough in individuals with neurological conditions and respiratory diseases, based on a review of 24 studies.

While EMST appears effective for airway protection in people with dysphagia due to neuromuscular issues, more research is necessary to validate and broaden the applicability of these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional outcomes associated with expiratory muscle strength training: narrative review. Laciuga, H., Rosenbek, JC., Davenport, PW., et al.[2014]

In a study involving 15 patients with multiple system atrophy (MSA), an 8-week expiratory muscle strength training (EMST) program significantly improved maximal expiratory pressure (MEP), indicating enhanced expiratory muscle strength (P = 0.006).

However, the training did not lead to significant improvements in voluntary peak cough flow (vPCF) (P = 0.845), suggesting that while EMST can strengthen muscles, it may not directly enhance cough effectiveness in MSA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expiratory Muscle Strength Training in Multiple System Atrophy: A Pilot Study. Srp, M., Bartosova, T., Klempir, J., et al.[2023]

A 4-week expiratory muscle strength training (EMST) program significantly improved maximum expiratory pressure (PEmax) in patients with Parkinson's disease, particularly in those training 5 days a week compared to a control group.

While overall quality of life did not change significantly, the 5-day training group showed notable improvements in mobility, indicating that EMST can enhance specific aspects of physical function in Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of expiratory muscle strength training intervention on the maximum expiratory pressure and quality of life of patients with Parkinson disease. Kuo, YC., Chan, J., Wu, YP., et al.[2018]

The Elevation Training Mask 2.0® (ETM) offers adjustable expiratory muscle strength resistance pressures, making it a potential alternative to traditional EMST devices for treating swallowing dysfunction.

Current results indicate that while the ETM provides lower resistance compared to the EMST150, it may still be effective for respiratory muscle strength training, warranting further research on its safety and clinical efficacy in patients with swallowing disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High elevation training mask as a respiratory muscle strength training tool for dysphagia. Shen, SC., Nachalon, Y., Randall, DR., et al.[2019]

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