NCT05644327 Exercise to Improve Sleep in Parkinson's Disease
| NCT ID | NCT05644327 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2021-09-01 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will investigate the impact of three common exercise modalities, cardiovascular, resistance, and multimodal (i.e., a combination of the previous two) training, on sleep quality and architecture in persons with Parkinson's disease (PD). Furthermore, the project will investigate whether the potential positive exercise-induced changes in sleep are associated with improvements in different quality of life (QoL)-related aspects. Participants will perform either cardiovascular training (CT), resistance training (RT), multimodal training (MT), or will be allocated to a control condition (i.e., waiting list - CON) for 12 weeks. Training will be performed three times/week. The assessments will be conducted at baseline, post-intervention, and follow-up (i.e. 8 weeks after the intervention) by assessors blinded to the participants' group allocation.
Eligibility Criteria
Inclusion Criteria: * Persons with mild-moderate idiopathic Parkinson's Disease (Modified Hoehn \& Yahr Scale stages 0.5-3.5); * On a stable dosage of medication during the previous month; * Having poor sleep quality defined as a score \> 15 in the PDSS-2 and/or reporting subjective sleep complaints affecting their sleep quality; Exclusion Criteria: * Having atypical parkinsonism, dementia, stroke, or any other neurological condition; * Presenting severe untreated obstructive sleep apnea (OSA); * Having a Montreal Cognitive Assessment (MoCA) score \<18 * Having a Beck Depression Inventory score \>31; * Having absolute contraindications to exercise; * Having severe osteoporosis; * Participating in an exercise or drug trial during the period of the study; * Exceeding the physical activity levels recommended for the general population (≥150 minutes/week of moderate-intensity or ≥75 minutes/week of vigorous-intensity cardiovascular activity) and/or strengthening activities ≥2 days/week.
Contact & Investigator
Marc Roig, Ph.D.
PRINCIPAL INVESTIGATOR
McGill University
Frequently Asked Questions
Who can join the NCT05644327 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05644327 currently recruiting?
Yes, NCT05644327 is actively recruiting participants. Contact the research team at marc.roigpull@mcgill.ca for enrollment information.
Where is the NCT05644327 trial being conducted?
This trial is being conducted at Laval, Canada, Montreal, Canada, Montreal, Canada.
Who is sponsoring the NCT05644327 clinical trial?
NCT05644327 is sponsored by McGill University. The principal investigator is Marc Roig, Ph.D. at McGill University. The trial plans to enroll 150 participants.
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