Exercise to Improve Sleep in Parkinson's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorMcGill University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Cardiovascular training (CT)

    Behavioral

    12 weeks of CT

  • Resistance training (RT)

    Behavioral

    12 weeks of RT

  • Multimodal training (MT)

    Behavioral

    12 weeks of MT

Treatment groups

150 Participants
are divided into 4 treatment groups
Group A: Cardiovascular training (CT)Experimental treatment 1 intervention
Group B: Resistance training (RT)Experimental treatment 1 intervention
Group C: Multimodal training (MT)Experimental treatment 1 intervention
Group D: Control condition (CON; waiting list)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks (post-intervention) and 8 weeks (follow-up)
2

Changes in subjective sleep quality

PD Sleep Scale version 2 (PDSS-2); values = 0-60; higher values reflect worse sleep quality.

Time frame
12 weeks (post-intervention) and 8 weeks (follow-up)
3

Changes in sleep architecture

Changes in slow-wave power measured with polysomnography.

Time frame
12 weeks (post-intervention) and 8 weeks (follow-up)
4

Changes in sleep architecture

Changes in sleep spindles density measured with polysomnography.

Time frame
12 weeks (post-intervention) and 8 weeks (follow-up)

Secondary outcomes

1

Changes in motor function

Unified PD Rating Scale part III (UPDRS part III); values = 0-132; higher values reflect worse motor function.

Time frame
12 weeks (post-intervention) and 8 weeks (follow-up)
2

Changes in cognitive function

Scale for Outcomes in PD-Cognition (SCOPA-COG); values = 0-43; higher values reflect better cognitive function.

Time frame
12 weeks (post-intervention) and 8 weeks (follow-up)
3

Changes in fatigue

PD Fatigue Scale; values = 16-80; higher values reflect worse fatigue.

Time frame
12 weeks (post-intervention) and 8 weeks (follow-up)
4

Changes in psychosocial functioning

Scale for Outcomes in PD-Psychosocial (SCOPA-PS); values = 0-100%; higher values (%) reflect worse psychosocial functioning.

Time frame
12 weeks (post-intervention) and 8 weeks (follow-up)

Other outcomes

1

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.

Time frame
12 weeks (post-intervention) and 8 weeks (follow-up)
2

Cardiorespiratory fitness

VO2 peak measured during a Graded Exercise Test (GXT)

Time frame
12 weeks (post-intervention) and 8 weeks (follow-up)

Sponsors and contacts

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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