Rehabilitation of Airway Protection in Parkinson's Disease

Part of paid clinical trials in West Lafayette, Indiana.

Sponsor
Teachers College, Columbia University
Study ID
NCT05700825
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Expiratory Muscle Strength Training + Cough Skill Training — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Aug 11, 2022
Status verified
Sep 2025
Primary completion
Sep 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: In-person
  • Experimental: Telehealth

Primary Outcome Measure

Change in Peak Expiratory Flow Rate (Cough PEFR) - phase 1 [ Time Frame: Pretraining to posttraining (after four weeks of intensive training) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Purdue UniversityWest LafayetteIndiana47907
Georgia Malandraki, PhD
[email protected]
Teachers College, Columbia UniversityNew YorkNew York10027-

Find similar trials in West Lafayette, IN

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Purdue University· West Lafayette, INTeachers College, Columbia University· New York, NY

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