Improve cognition via resistance training
- Trial ID
- NCT04796506
- Official Title
- Slow Wave Sleep As a Biomarker of Rehabilitation-induced Cognitive Improvement in Parkinson's Disease R01 HD100670
- Goal
- Improve cognition via resistance training
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Colorado, Denver
- Study Type
- INTERVENTIONAL
- Enrollment
- 120 participants
- Conditions
- Parkinson Disease
- Interventions
- Progressive Resistance Training (PRT), Delayed Exercise Training (DE), Endurance Training (ET)
Summary For Families
They want to know whether targeted exercise can improve thinking and memory in people with mid-stage Parkinson's, and whether increases in slow wave sleep, the deep sleep that helps consolidate memories, can serve as a measurable sign of those brain changes. Participants are randomized to progressive resistance training, aerobic endurance training, or a delayed-exercise group; strength training builds muscle and motor control and promotes brain plasticity, while aerobic training raises heart rate and cardiorespiratory fitness and can deepen slow wave sleep, and the study tracks sleep and cognitive tests to link sleep changes with cognitive benefit. The trial seeks people aged 45 and older with idiopathic PD at Hoehn and Yahr stage 2 or 3, mild cognitive impairment range on the MoCA (scores 18 to 25), on stable medications and able to safely exercise, and excludes those with deep brain stimulation, untreated sleep apnea, regular exercise habits, significant heart or lung disease, or signs of atypical Parkinsonism.
Locations
- University of Colorado, Anschutz Medical Campus, Aurora, Colorado, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Progressive Resistance Training (PRT). They want to know whether targeted exercise can improve thinking and memory in people with mid-stage Parkinson's, and whether increases in slow wave sleep, the deep sleep that helps consolidate memories, can serve as a measurable sign of those brain changes. Participants are randomized to progressive resistance training, aerobic endurance training, or a delayed-exercise group; strength training builds muscle and motor control and promotes brain plasticity, while aerobic training raises heart rate and cardiorespiratory fitness and can deepen slow wave sleep, and the study tracks sleep and cognitive tests to link sleep changes with cognitive benefit. The trial seeks people aged 45 and older with idiopathic PD at Hoehn and Yahr stage 2 or 3, mild cognitive impairment range on the MoCA (scores 18 to 25), on stable medications and able to safely exercise, and excludes those with deep brain stimulation, untreated sleep apnea, regular exercise habits, significant heart or lung disease, or signs of atypical Parkinsonism.
- Who can participate?
- Participants must be between 45 Years and 100 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 9 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.