RecruitingNot applicable

Genetics and Aerobic Exercise to Slow Parkinson's Disease Trial

Genetics and Aerobic Exercise to Slow Parkinson's Disease (GEARS) Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits
  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will exercise at community-based sites 3x/week for 12 months."
  • "Following the two enrollment visits, the participant will begin attending PFP classes 3x/wk at the community center most convenient to them."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how genes and exercise may work together to slow Parkinson's disease. It is for 200 adults with Parkinson's in the Cleveland and Salt Lake City areas. Participants will have genetic testing and ride stationary bikes at community sites 3 times a week for 12 months.

The proposed multi-site, Genetics and Aerobic Exercise to Slow PD (GEARS) Trial will, for the first time, determine the interplay between genetics and exercise in altering PD progression. In sum, 200 PD patients will be recruited from the Cleveland and Salt Lake City metro areas to participate in the Pedaling for Parkinson's (PFP) community-based exercise program. Participants will exercise at community-based sites 3x/week for 12 months. All participants will undergo genotyping using an array that includes the genome backbone and common risk variants associated to increase risk for multiple neurological disorders including PD.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are an adult diagnosed with Parkinson's by a doctor or another qualified health care provider.
  • Your Parkinson's is at stage 1–3 on the Hoehn and Yahr scale, which measures how severe symptoms are.
  • You can safely get on and off a stationary bike.
  • You have reliable transportation to the community exercise site.
  • You have a smartphone to track activity data.
  • You take a steady dose of Parkinson's medicine.

Who can't join

  • You are in another Parkinson's study testing a treatment meant to change how the disease progresses.
  • You have dementia or other thinking problems that prevent you from understanding and agreeing to join.
  • You have implanted deep brain stimulation electrodes or have had focused ultrasound treatment for Parkinson's.
  • A health screening says you need medical approval to exercise, but you do not get approval from your health care provider.
  • You have a muscle, bone, or joint problem, such as arthritis, weak bones, or back problems, that limits your ability to cycle.
  • You have a nervous system disease other than Parkinson's, such as multiple sclerosis or stroke.
  • You currently have an abnormal heart rhythm.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Adult with a diagnosis of PD by a physician or physician extender 2. Hoehn and Yahr stage I-III 3. Demonstrate the ability to safely mount and dismount a stationary cycle 4. Reliable transportation to the community exercise facility 5. Smartphone device for activity data monitoring 6. On a stable dose of anti-parkinsonian medication Exclusion Criteria: 1. Participation in disease modifying PD-related clinical trial or study 2. Diagnosis of dementia or any neurocognitive impairment that compromises one's ability to provide informed consent. 3. Implanted deep brain stimulation electrodes or focused ultrasound for PD management 4. Recommendation for medical clearance using the American College of Sports Medicine (ACSM) Preparticipation Health Screen a. If the ACSM screen recommends medical clearance, the participant must obtain medical clearance by their health care provider prior to participation. b. Those who choose not to obtain physician clearance will not be eligible for participation. e) A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in a cycling intervention f) Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke) g) Current cardiac arrhythmia

Study sites (1)

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