Progressive Resistance Training for Parkinson's (NCT04796506)
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
- UNKNOWN
- 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?
- 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 9 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?
- This trial has 2 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- If randomized to progressive resistance training (PRT) you will have supervised PRT 3 times per week for 12 weeks; after the first 12 weeks responders will continue PRT for an additional 12 weeks and non-responders will transition to endurance training (ET).