Exercise and Sleep in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

The Effect of Different Exercise Modalities on Sleep Quality and Architecture in People With Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04558879
• Other study ID #: 35450
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2024
• Source: McGill University
• Contact: Marc Roig, PhD
• Phone: 514-398-4400
• Email: marc.roigpull[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the impact of two common exercise modalities, cardiovascular and resistance training, on sleep quality and architecture in persons with Parkinson's disease (PD), and whether these potential positive changes in sleep are associated with improvements in brain plasticity and different quality of life (QoL)-related aspects. Participants will perform either cardiovascular training (CT) or resistance training (RT) for 12 weeks, at least two times/week. The assessments will be performed at baseline and after training by an assessor blinded to the participants' group allocation.

Description:

Background: Over 100,000 Canadians are currently living with PD. Every year, 6.600 new cases are diagnosed and this number is expected to double by 2031. Most (98%) of those persons experience sleep problems, which can appear even before the onset of the cardinal motor symptoms of the disease, affecting multiple aspects of their QoL. Persons with PD also show alterations in sleep architecture, which have been associated with faster disease progression. Since medications used to reduce sleep problems in PD have potential adverse side effects, exercise has been proposed as a potential non-pharmacological alternative to improve sleep quality and architecture in people with PD. However, the most beneficial type of intervention to improve sleep in this clinical population is still to be determined.

Objective: 1) To conduct a 12-week RCT comparing the effects of CT and RT on both objective and subjective measures of sleep quality and architecture in patients with mild-to-moderate PD; 2) To assess whether, regardless of the type of exercise, positive changes in sleep quality and architecture mediate exercise-induced improvements in cognitive and motor function as well as in different aspects that directly impact on QoL; 3) To explore whether, regardless of the type of exercise used, positive changes in sleep architecture will be associated with improvements in brain plasticity and motor learning.

Design: a single-blinded RCT in which assessments will be performed at baseline (pre) and after (post) training by an assessor blinded to the participants' group allocation.

Outcomes: 1) objective and subjective sleep quality as well as sleep architecture; 2) cognitive and motor function as well as fatigue, psychological functioning, and QoL; 3) motor learning and brain plasticity.

Methods: Changes in objective (i.e. sleep efficiency) and subjective measures of sleep quality will be assessed with actigraphy and the PD sleep scale version 2, respectively. Sleep architecture will be measured with polysomnography. Motor and cognitive function will be assessed with the Unified PD Rating Scale and the Scale for Outcomes in PD-Cognition, respectively. Fatigue, psychosocial functioning and QoL will be assessed with the PD Fatigue Scale, the Scale for Outcomes in PD-Psychosocial and the PD QoL Scale, respectively. Motor learning will be assessed using a visuomotor tracking task; whereas brain plasticity will be measured with transcranial magnetic stimulation applied over the primary motor cortex.

Expected results: 1) CT will be more effective than RT in improving objective and subjective sleep quality. RT and CT will be equally effective in improving sleep architecture; 2) Improvements in sleep quality and architecture will be associated with enhancements in cognition, motor function and different QoL-related aspects; 3) Positive changes in sleep architecture will mediated increases in brain plasticity and motor learning.

Impact: This will be the first study comparing the effect of CT and RT on sleep quality and architecture and exploring associations with cognitive and motor function as well as aspects that directly impact QoL. The results of the study will provide important information to design more personalized exercise-based treatments, which are patient-oriented and aimed to mitigate sleep complains in this clinical population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• Persons with mild-moderate idiopathic Parkinson's Disease (Modified Hoehn & Yahr Scale stages 1-3);

• On a stable dosage of medication during the previous month;

• Having poor sleep quality defined as a score > 18 in the PDSS-2(scores above this cut-off value define clinically relevant sleep disorders);

Exclusion Criteria:

• Having atypical parkinsonism, dementia or any other neurological, psychiatric or cardiovascular comorbidity affecting the ability to perform exercise;

• Presenting severe untreated obstructive sleep apnea (OSA);

• Having a Montreal Cognitive Assessment (MoCA) score <21

• Having a Beck Depression Inventory (BDI version 2) score >4

• Having absolute contraindications to exercise and to undergo transcranial magnetic stimulation (TMS);

• Currently are or will be enrolled in a drug or exercise trial during the duration of the study;

• Having participated in a structured exercise program > 2 times per week in the two months prior to the enrollment in the study

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• CT
12 weeks of exercise Cardiovascular Training
• RT
12 weeks of exercise Resistance Training

Locations

Country	Name	City	State
Canada	Jewish Rehabiliation Hospital	Laval	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University	Jewish Rehabilitation Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intra-cortical facilitation	Paired-pulse of transcranial magnetic stimulation (TMS) protocol to estimate variation in cortical excitability measured as motor evoked potential (MEP).	12 weeks
Other	Short intra-cortical inhibition	Paired-pulse of transcranial magnetic stimulation (TMS) protocol to estimate variation in cortical excitability measured as motor evoked potential (MEP).	12 weeks
Other	Silent period	Paired-pulse of transcranial magnetic stimulation (TMS) protocol to estimate variation in cortical excitability measured as length of the pause in electromyographic activity.	12 weeks
Other	Cardiorespiratory fitness	Maximum rate of oxygen consumption measured during maximum physical effort.	12 weeks
Primary	Sleep efficiency (SE)	Actigraphy; SE = total sleep time/time spent in bed.	12 weeks
Primary	Subjective sleep quality	Parkinson's Disease Sleep Scale version 2 (PDSS-2); Score range from 0-60; higher scores represent worse sleep quality.	12 weeks
Primary	Objective sleep measurements, including duration and percentage of sleep stages, total sleep time (TLT), wake after sleep onset (WASO), sleep latency (SL).	Polysomnography combined with electroencephalogram	12 weeks
Secondary	Motor function	Unified Parkinson's Disease Rating Scale part III; Scores range from 0-56; higher scores represent a worse motor function.	12 weeks
Secondary	Cognition	Scale for Outcomes in Parkinson's Disease-Cognition; Scores range from 0-43; higher scores reflect better performance.	12 weeks
Secondary	Fatigue	Parkinson's Disease Fatigue Scale; Scores range from 16-80; higher scores reflect a higher presence of fatigue.	12 weeks
Secondary	Psychosocial functioning	Scale for Outcomes in Parkinson's Disease-Psychosocial; Scores range from 0-33; higher scores reflect a worse psychosocial functioning.	12 weeks
Secondary	Quality of life-related aspects in Parkinson's disease	Parkinson's Disease Quality of Life Scale; Scores range from 0-128; higher scores indicate lower quality of life.	12 weeks
Secondary	Motor learning	Visuomotor tracking task; accuracy in performing a novel motor task with the dominant hand.	12 weeks