About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Cardiovascular training (CT)
Behavioral12 weeks of CT
Resistance training (RT)
Behavioral12 weeks of RT
Multimodal training (MT)
Behavioral12 weeks of MT
Treatment groups
Trial outcomes
Primary outcomes
Changes in objective sleep quality
Sleep efficiency (SE) measured with polysomnography; SE (%) = Time asleep while in bed \* 100; values = 0-100%; higher values reflect better SE.
Changes in subjective sleep quality
PD Sleep Scale version 2 (PDSS-2); values = 0-60; higher values reflect worse sleep quality.
Changes in sleep architecture
Changes in slow-wave power measured with polysomnography.
Changes in sleep architecture
Changes in sleep spindles density measured with polysomnography.
Secondary outcomes
Changes in motor function
Unified PD Rating Scale part III (UPDRS part III); values = 0-132; higher values reflect worse motor function.
Changes in cognitive function
Scale for Outcomes in PD-Cognition (SCOPA-COG); values = 0-43; higher values reflect better cognitive function.
Changes in fatigue
PD Fatigue Scale; values = 16-80; higher values reflect worse fatigue.
Changes in psychosocial functioning
Scale for Outcomes in PD-Psychosocial (SCOPA-PS); values = 0-100%; higher values (%) reflect worse psychosocial functioning.
Other outcomes
Inflammatory biomarkers
peripheral concertation of pro-inflammatory blood biomarkers (e.g., IL-6, Il-1, TNF-α); values of pro-inflammatory blood biomarkers will be reported as pg/ml.
Cardiorespiratory fitness
VO2 peak measured during a Graded Exercise Test (GXT)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
McGill University
Lead sponsor
Jewish Rehabilitation Hospital
Collaborator
The Memory Lab
Collaborator
The Human Brain Control of Locomotion Lab (HBCL)
Collaborator
The Cummings Centre
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator