High intensity stationary cycling for Parkinson's (NCT06442033)
High intensity cycling slows Parkinson
- Trial ID
- NCT06442033
- Official Title
- Genetics and Aerobic Exercise to Slow Parkinson's Disease (GEARS) Trial
- Goal
- High intensity cycling slows Parkinson
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Jay Alberts
- Study Type
- INTERVENTIONAL
- Enrollment
- 200 participants
- Conditions
- Parkinson Disease
- Interventions
- High intensity stationary cycling
Summary For Families
The GEARS trial (Genetics and Aerobic Exercise to Slow Parkinson's Disease) is testing whether regular, high-intensity cycling in community classes can slow Parkinson's progression and whether a person’s genes change how much benefit they get. Participants will join the Pedaling for Parkinson's program and ride a stationary bike three times a week for 12 months, while researchers also do genetic testing to calculate a risk score and compare changes over time; participants will have checkups both while on their medication and after about 12 hours off medication so researchers can see the direct effects of exercise. The trial will enroll 200 adults with a physician diagnosis of Parkinson's in early to mid stages (stage I to III) who can safely get on and off a stationary bike, can travel to a community exercise site, have a smartphone for activity tracking, and are on a stable Parkinson's medication plan. People with dementia or serious memory problems, implanted brain devices for Parkinson's, other major neurological diseases, certain heart rhythm or musculoskeletal issues, or current participation in another disease-modifying trial are not eligible.
Locations
- The Cleveland Clinic, Cleveland, Ohio, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying High intensity stationary cycling. The GEARS trial (Genetics and Aerobic Exercise to Slow Parkinson's Disease) is testing whether regular, high-intensity cycling in community classes can slow Parkinson's progression and whether a person’s genes change how much benefit they get. Participants will join the Pedaling for Parkinson's program and ride a stationary bike three times a week for 12 months, while researchers also do genetic testing to calculate a risk score and compare changes over time; participants will have checkups both while on their medication and after about 12 hours off medication so researchers can see the direct effects of exercise. The trial will enroll 200 adults with a physician diagnosis of Parkinson's in early to mid stages (stage I to III) who can safely get on and off a stationary bike, can travel to a community exercise site, have a smartphone for activity tracking, and are on a stable Parkinson's medication plan. People with dementia or serious memory problems, implanted brain devices for Parkinson's, other major neurological diseases, certain heart rhythm or musculoskeletal issues, or current participation in another disease-modifying trial are not eligible.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- 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 trial is estimated to last approximately 4 years and 4 months.
- 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?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- How many visits does this trial involve?
- Five in-person assessments are required over a total study duration of about 12.5 months.
- 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.