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?
- 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 6 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.