Cycling slows Parkinson disease progression
- Trial ID
- NCT06442033
- Official Title
- Genetics and Aerobic Exercise to Slow Parkinson's Disease (GEARS) Trial
- Goal
- Cycling slows Parkinson disease progression
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Jay Alberts
- Study Type
- INTERVENTIONAL
- Enrollment
- 200 participants
- Conditions
- Parkinson Disease
- Interventions
- High intensity stationary cycling
Summary For Families
GEARS is testing whether high-intensity aerobic exercise, analyzed alongside participants' genetic information, can slow Parkinson's progression and improve motor function. The plan uses supervised high-intensity stationary cycling to raise heart rate and boost brain-protective growth factors like BDNF, which may strengthen motor circuits and slow neurodegeneration; exercise is used alongside, not instead of, usual medicines and participants stay on a stable anti-parkinsonian regimen. The trial is looking for adults 18 and older with Parkinson's at Hoehn and Yahr stages 1 to 3 who can safely mount a stationary bike, have reliable transportation and a smartphone for activity tracking, and are on stable medication. People with dementia, implanted DBS or focused ultrasound, certain heart or musculoskeletal problems, other neurological diseases, or current participation in another disease-modifying PD trial are not eligible, and anyone flagged by the ACSM screen must get medical clearance first.
Locations
- The Cleveland Clinic, Cleveland, Ohio, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying High intensity stationary cycling. GEARS is testing whether high-intensity aerobic exercise, analyzed alongside participants' genetic information, can slow Parkinson's progression and improve motor function. The plan uses supervised high-intensity stationary cycling to raise heart rate and boost brain-protective growth factors like BDNF, which may strengthen motor circuits and slow neurodegeneration; exercise is used alongside, not instead of, usual medicines and participants stay on a stable anti-parkinsonian regimen. The trial is looking for adults 18 and older with Parkinson's at Hoehn and Yahr stages 1 to 3 who can safely mount a stationary bike, have reliable transportation and a smartphone for activity tracking, and are on stable medication. People with dementia, implanted DBS or focused ultrasound, certain heart or musculoskeletal problems, other neurological diseases, or current participation in another disease-modifying PD trial are not eligible, and anyone flagged by the ACSM screen must get medical clearance first.
- 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?
- 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 4 years and 4 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.