Rehabilitation of Airway Protection in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Rehabilitation of Airway Protection in Parkinson's Disease: Comparing In-person and Telehealth Service Delivery Models

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05700825
• Other study ID #: NS126319
• Secondary ID: 1R01NS126319
• Status: Recruiting
• Phase: Phase 2
• Start date: August 11, 2022
• Est. completion date: September 1, 2027

Study information

• Verified date: June 2024
• Source: Teachers College, Columbia University
• Contact: Michelle Troche, PhD
• Phone: 212-678-3072
• Email: uadlab[@]tc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Airway protective disorders are a prevalent and progressive consequence of Parkinson's Disease (PD), and often result in aspiration pneumonia which is the leading cause of death in PD. Despite this, a large number of patients with PD do not access specialized services to address these critical deficits. The investigators will examine the comparative effectiveness of a novel treatment paradigm delivered in-person versus via telehealth in persons with PD, as well as the role of patient burden and treatment adherence on outcomes; thus, the proposed research is relevant to public health and in line with NIH's mission to identify novel, efficacious, and accessible rehabilitation strategies for short- and long-term improvement of dysfunctional airway protection in PD.

Description:

Progressive disorders of airway protection, such as swallowing disorders (dysphagia) and cough disorders (dystussia), are highly prevalent in PD and have significant negative implications for health and quality of life. In fact, aspiration pneumonia, commonly associated with dysphagia/dystussia, is a leading cause of death in PD. Despite this, there is currently no established standard of care for the treatment of airway protective disorders in this population. Even more critically, approximately 40% of individuals with PD in the United States do not access rehabilitation services or receive specialized care for these potentially life-threatening airway protective deficits. Expiratory Muscle Strength Training (EMST) and Cough Skill Training (CST) have been found to improve airway protective disorders in PD and be feasible via telehealth. However, a significant clinical-research gap remains in that it has not been demonstrated that clinical outcomes are comparable (non-inferior) when these treatments are delivered via telehealth versus in-person. This gap limits access to these important services with detrimental effects to health and quality of life. The long-term goal of this line of research is to improve the health outcomes of individuals with PD, specifically as they relate to airway protective dysfunction. The objective of this application is to pair EMST + CST - and compare clinical and patient-centered outcomes when conducted in-person versus via telehealth in the short- and the long-term. Also, the investigators will assess the role of specific patient burden factors and resultant treatment adherence on clinical outcomes. Therefore, the aims of this study are to: 1) Compare clinical and patient-centered outcomes following four weeks of intensive in-person vs. telehealth EMST+CST treatment in persons with PD, 2) Compare clinical and patient-centered outcomes from a long-term EMST+CST maintenance program offered in-person vs. via telehealth in persons with PD, and 3) Identify the role of specific patient burden factors (i.e., geographic location, cognitive function, disease severity, and caregiver burden) on treatment adherence in the short- and long-term and the influence of treatment adherence on clinical outcomes. The investigators will achieve these aims by conducting a two-arm, two site, randomized clinical trial in 120 people with PD comparing in-person vs. telehealth EMST+CST treatment after a four-week intensive period (aim1) and after a one year maintenance treatment period (with assessments at six and 12 months - aim 2). The investigators anticipate our findings will result in immediately translatable clinical deliverables that will have broad impact for reduced burden and improved accessibility of treatment. Further, these findings will inform our future studies investigating these treatments and service delivery models on long-term outcomes (i.e., aspiration pneumonia, hospitalization, death), accessibility, and healthcare costs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion criteria:

• Diagnosed with PD (Hoehn and Yahr Stages II-IV)126,127 confirmed by a Movement Disorders fellowship trained neurologist having reviewed the video recorded Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assessment for each participant and using strict UK brain bank criteria

• airway protective deficits as defined as a minimum of penetration of thin liquids (penetration-aspiration score>3) as determined by instrumental swallowing assessment and/or dystussia as determined by voluntary cough assessment (PEFR =4.1 L/s)

• not actively receiving exercise-based swallowing therapy

• between the ages of 50 and 90.

Exclusion criteria:

• Other neurological disorders (e.g., multiple sclerosis, stroke, brain tumor, etc.)

• history of head and neck cancer

• history of breathing disorders or diseases (e.g., COPD)

• history of smoking in the last five years

• uncontrolled hypertension

• difficulty complying due to neuropsychological dysfunction (i.e., severe depression with >28 on the Beck Depression Index (BDI-II), dementia with <19 on the Montreal Cognitive Assessment (MoCA))

• allergy to capsaicin or barium

• further than 1.5 hours (door to door) distance from either Teachers College, Columbia University or Purdue University.

Related Conditions & MeSH terms

• Dysphagia
• Parkinson Disease

Intervention

Behavioral:
• Expiratory Muscle Strength Training + Cough Skill Training
Expiratory Muscle Strength Training (EMST). EMST is a widely used and efficacious treatment approach that uses a calibrated device with a one-way, spring-loaded pressure relief valve to mechanically overload the expiratory and submental muscles. Cough Skill Training (CST) involves a digital peak flow meter device which measures PEFR (peak expiratory flow rate) in liters/second and allows patients to receive immediate biofeedback.

Locations

Country	Name	City	State
United States	Teachers College, Columbia University	New York	New York
United States	Purdue University	West Lafayette	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Teachers College, Columbia University	National Institute of Neurological Disorders and Stroke (NINDS), Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Peak Expiratory Flow Rate (Cough PEFR) - phase 1		Pretraining to posttraining (after four weeks of intensive training)
Primary	Change in Peak Expiratory Flow Rate (Cough PEFR) - phase 2		post-training to post one-year maintenance
Primary	Change in Penetration-Aspiration Scale (PAS) - phase 1	PAS, max value: 8 (most impaired), min value 1 (least impaired).	Pretraining to posttraining (after four weeks of intensive training)
Primary	Change in Penetration-Aspiration Scale (PAS) - phase 2	PAS, max value: 8 (most impaired), min value 1 (least impaired).	post-training to post one-year maintenance
Secondary	Change in Maximum Expiratory Pressure - phase 1		Pretraining to posttraining (after four weeks of intensive training)
Secondary	Change in Maximum Expiratory Pressure - phase 2		post-training to post one-year maintenance
Secondary	Change in Cough expired volume - phase 1		Pretraining to posttraining (after four weeks of intensive training)
Secondary	Change in Cough expired volume - phase 2		post-training to post one-year maintenance
Secondary	Treatment Adherence - phase 1	percent of prescribed training coughs and breaths completed	posttraining (after four weeks of intensive training)
Secondary	Change in Treatment Adherence- phase 2	percent of prescribed training coughs and breaths completed	post-training to post one-year maintenance
Secondary	Change in SWAL-QOL- phase 1	self-report questionnaire of swallowing quality of life, 44 min score, 220 max score - higher score is better QOL	Pretraining to posttraining (after four weeks of intensive training)
Secondary	Change in SWAL-QOL - phase 2	self-report questionnaire of swallowing quality of life, 44 min score, 220 max score - higher score is better QOL	post-training to post one-year maintenance