Parkinson's Trial NCT07680725
Build breathing muscles and balance
- Trial ID
- NCT07680725
- Official Title
- The Effect of Bottle PEP Exercise on Expiratory Muscle Thickness, Strength, and Balance Parameters in Parkinson's Disease Patients
- Goal
- Build breathing muscles and balance
- Status
- RECRUITING
- Sponsor
- Marmara University
- Study Type
- OBSERVATIONAL
- Enrollment
- 42 participants
- Conditions
- Parkinson Disease (PD)
Summary For Families
Researchers are testing whether adding a simple bottle-based positive expiratory pressure device to routine neurological rehab can strengthen the muscles used for breathing out, increase their thickness, and improve balance in people with Parkinson's. The plan compares two groups: one does standard breathing-out strengthening exercises and the other uses a homemade bottle device (a 1.5-liter bottle with 10 cm of water and a tube) to do 25 forceful exhalations after deep breaths, five days a week for eight weeks; the bottle creates resistance when you breathe out, which helps keep airways open and can aid clearing secretions. Participants learn the exercises in person, are checked by a researcher over video calls, and are tested before the program, after eight weeks, and again eight weeks later. The trial is looking for ambulatory adults age 18 to 75 with confirmed Parkinson's who can follow the program and do not have active lung disease, major heart disease, active cancer, recent thoracic or abdominal surgery, significant hearing or thinking problems, or current smoking.
Locations
- Marmara University Medical Faculty, Istanbul, Maltepe, Turkey (Türkiye)
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. Researchers are testing whether adding a simple bottle-based positive expiratory pressure device to routine neurological rehab can strengthen the muscles used for breathing out, increase their thickness, and improve balance in people with Parkinson's. The plan compares two groups: one does standard breathing-out strengthening exercises and the other uses a homemade bottle device (a 1.5-liter bottle with 10 cm of water and a tube) to do 25 forceful exhalations after deep breaths, five days a week for eight weeks; the bottle creates resistance when you breathe out, which helps keep airways open and can aid clearing secretions. Participants learn the exercises in person, are checked by a researcher over video calls, and are tested before the program, after eight weeks, and again eight weeks later. The trial is looking for ambulatory adults age 18 to 75 with confirmed Parkinson's who can follow the program and do not have active lung disease, major heart disease, active cancer, recent thoracic or abdominal surgery, significant hearing or thinking problems, or current smoking.
- Who can participate?
- Participants must be between 18 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year.
- 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?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- How many visits does this trial involve?
- You will be evaluated at the beginning of the study, at the end of the 8th week, and 8 weeks after completing the exercise program.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.