Cardiovascular training for Parkinson's (NCT05644327)
Improve sleep quality through exercise
- Trial ID
- NCT05644327
- Official Title
- The Effects of Different Exercise Modalities on Sleep Quality and Architecture in People With Parkinson's Disease
- Goal
- Improve sleep quality through exercise
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- McGill University
- Study Type
- INTERVENTIONAL
- Enrollment
- 150 participants
- Conditions
- Parkinson Disease
- Interventions
- Cardiovascular training (CT), Resistance training (RT), Multimodal training (MT)
Summary For Families
They want to find which kind of exercise best improves sleep quality and the makeup of sleep in people with Parkinson's, for example increasing deep restorative sleep and cutting down nighttime awakenings. Participants are assigned to cardiovascular training, resistance training, or a combined program, with cardio raising heart rate and aerobic fitness to strengthen circadian cues and slow wave sleep, resistance work building muscle to reduce nighttime stiffness and sleep disruption, and the combined approach doing both. Exercise here is a nonpharmacologic complement to medications like levodopa; it does not change how levodopa works but may lessen nocturnal motor symptoms and improve sleep without adding drug side effects. The trial seeks adults 40 and over with mild to moderate idiopathic Parkinson's (Hoehn and Yahr 0.5,3.5), on stable meds and reporting poor sleep (PDSS-2 >15), while excluding people with dementia, severe untreated sleep apnea, major cognitive or depressive impairment, serious exercise contraindications, or who are already highly active.
Locations
- Jewish Rehabilitation Hospital, Laval, Quebec, Canada
- Human Brain Control of Locomotion Laboratory, Montreal, Quebec, Canada
- Cummings Centre, Montreal, Quebec, Canada
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Cardiovascular training (CT). They want to find which kind of exercise best improves sleep quality and the makeup of sleep in people with Parkinson's, for example increasing deep restorative sleep and cutting down nighttime awakenings. Participants are assigned to cardiovascular training, resistance training, or a combined program, with cardio raising heart rate and aerobic fitness to strengthen circadian cues and slow wave sleep, resistance work building muscle to reduce nighttime stiffness and sleep disruption, and the combined approach doing both. Exercise here is a nonpharmacologic complement to medications like levodopa; it does not change how levodopa works but may lessen nocturnal motor symptoms and improve sleep without adding drug side effects. The trial seeks adults 40 and over with mild to moderate idiopathic Parkinson's (Hoehn and Yahr 0.5,3.5), on stable meds and reporting poor sleep (PDSS-2 >15), while excluding people with dementia, severe untreated sleep apnea, major cognitive or depressive impairment, serious exercise contraindications, or who are already highly active.
- Who can participate?
- Participants must be at least 40 Years.
- Where is this trial located?
- This trial is recruiting at 3 locations.
- 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 6 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?
- This trial has a group that receives no study treatment (you would continue your usual care) alongside the treatment groups. Because assignment is random, you have about a 1 in 4 chance (roughly 25%) of being in the no-treatment group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- Assessments are performed at baseline, after 12 weeks of training, and at an 8-week post-intervention follow-up.