Recruiting
Phase 2

Rehabilitation

Sponsor:

Teachers College, Columbia University

Code:

NCT05700825

Conditions

Parkinson Disease

Dysphagia

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Expiratory Muscle Strength Training + Cough Skill Training

Study Details

Brief 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.

Conditions

Parkinson Disease

Dysphagia

Study ID

NCT05700825

Start date

Aug 11, 2022

Status verified date

Sep, 2025

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: In-person

experimental: Telehealth

Interventions

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.

Primary outcome measure

  • Change in Peak Expiratory Flow Rate (Cough PEFR) - phase 1 [ Time Frame: Pretraining to posttraining (after four weeks of intensive training) ]
  • Change in Peak Expiratory Flow Rate (Cough PEFR) - phase 2 [ Time Frame: post-training to post one-year maintenance ]
  • Change in Penetration-Aspiration Scale (PAS) - phase 1 [ Time Frame: Pretraining to posttraining (after four weeks of intensive training) ]
  • Change in Penetration-Aspiration Scale (PAS) - phase 2 [ Time Frame: post-training to post one-year maintenance ]

Central Contacts and Locations

Central contacts

Michelle Troche, PhD

212-678-3072uadlab@tc.columbia.edu

Locations

Purdue University

Recruiting

West Lafayette, Indiana, United States, 47907

Contacts

Georgia Malandraki, PhD

malandraki@purdue.edu

More Information

Sponsor

Teachers College, Columbia University

Last update posted

Sep 24, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Teachers College, Columbia University on 2025-09-24.