Expiratory Muscle Strength Trainin… for Parkinson's (NCT05700825)
Strengthen cough to reduce aspiration
- Trial ID
- NCT05700825
- Official Title
- Rehabilitation of Airway Protection in Parkinson's Disease: Comparing In-person and Telehealth Service Delivery Models
- Goal
- Strengthen cough to reduce aspiration
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Teachers College, Columbia University
- Study Type
- INTERVENTIONAL
- Enrollment
- 120 participants
- Conditions
- Parkinson Disease, Dysphagia
- Interventions
- Expiratory Muscle Strength Training + Cough Skill Training
Summary For Families
The goal is to improve airway protection so people with Parkinson's swallow more safely and have fewer episodes of choking or food and liquids entering the lungs. The program uses expiratory muscle strength training to strengthen the muscles you use to breathe out so you can generate a stronger, more effective cough, plus cough skill training to teach timing and technique, and it is being tested both in person and via telehealth to see if remote delivery works as well. This is a behavioral exercise program, not a drug, so it does not interact with levodopa or other Parkinson's medications. They are enrolling people ages 50 to 90 with Parkinson's at Hoehn and Yahr stages II to IV who show airway protection problems on instrumental swallowing tests or a weak voluntary cough, are not currently doing exercise-based swallowing therapy, and who do not have other neurologic, serious respiratory, recent smoking, uncontrolled hypertension, or severe cognitive or psychiatric issues.
Locations
- Purdue University, West Lafayette, Indiana, United States
- Teachers College, Columbia University, New York, New York, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Expiratory Muscle Strength Training + Cough Skill Training. The goal is to improve airway protection so people with Parkinson's swallow more safely and have fewer episodes of choking or food and liquids entering the lungs. The program uses expiratory muscle strength training to strengthen the muscles you use to breathe out so you can generate a stronger, more effective cough, plus cough skill training to teach timing and technique, and it is being tested both in person and via telehealth to see if remote delivery works as well. This is a behavioral exercise program, not a drug, so it does not interact with levodopa or other Parkinson's medications. They are enrolling people ages 50 to 90 with Parkinson's at Hoehn and Yahr stages II to IV who show airway protection problems on instrumental swallowing tests or a weak voluntary cough, are not currently doing exercise-based swallowing therapy, and who do not have other neurologic, serious respiratory, recent smoking, uncontrolled hypertension, or severe cognitive or psychiatric issues.
- Who can participate?
- Participants must be between 50 Years and 90 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 5 years and 1 month.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.