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Exercise and Sleep in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CT
RT
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Rehabilitation, Neurosciences, Sleep, Exercise, Cardiovascular training, Resistance training, Cognition, Motor function, Quality of life

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jewish Rehabiliation HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cardiovascular training

Resistance training

Arm Description

Cardiovascular training (CT) will be performed on a recumbent stepper. CT will start at low intensity, and through a linear progression will reach vigorous intensity; then, this intensity will be maintained until the end of the intervention. Each session will include five minutes of warm-up and cool-down performed at the beginning and the end of the training, respectively. Furthermore, five minutes of stretching will be performed after the cool down. CT's sessions will approximately last 45 minutes and will be interspersed with at least 48 hours of recovery.

Resistance training (RT) intensity will be estimated using the percentage of one-maximal repetition (1-RM) defined as the maximal weight liftable for ten maximal repetitions with proper form. The program will include five exercises (leg press, lat machine, leg extension, leg curl, bench press) and will start at high-volume low-intensity. RT will follow a periodization to reach high-intensity low-volume at the end of the intervention (week 12). The training sessions will start with five-minute of warm-up performed on a recumbent stepper and will end with five-minute of stretching (cool-down). RT's sessions will approximately last 45 minutes and will be interspersed with at least 48 hours of recovery.

Outcomes

Primary Outcome Measures

Sleep efficiency (SE)
Actigraphy; SE = total sleep time/time spent in bed.
Subjective sleep quality
Parkinson's Disease Sleep Scale version 2 (PDSS-2); Score range from 0-60; higher scores represent worse sleep quality.
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

Secondary Outcome Measures

Motor function
Unified Parkinson's Disease Rating Scale part III; Scores range from 0-56; higher scores represent a worse motor function.
Cognition
Scale for Outcomes in Parkinson's Disease-Cognition; Scores range from 0-43; higher scores reflect better performance.
Fatigue
Parkinson's Disease Fatigue Scale; Scores range from 16-80; higher scores reflect a higher presence of fatigue.
Psychosocial functioning
Scale for Outcomes in Parkinson's Disease-Psychosocial; Scores range from 0-33; higher scores reflect a worse psychosocial functioning.
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.
Motor learning
Visuomotor tracking task; accuracy in performing a novel motor task with the dominant hand.

Full Information

First Posted
September 9, 2020
Last Updated
October 17, 2023
Sponsor
McGill University
Collaborators
Jewish Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04558879
Brief Title
Exercise and Sleep in Parkinson's Disease
Official Title
The Effect of Different Exercise Modalities on Sleep Quality and Architecture in People With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University
Collaborators
Jewish Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, Rehabilitation, Neurosciences, Sleep, Exercise, Cardiovascular training, Resistance training, Cognition, Motor function, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiovascular training
Arm Type
Experimental
Arm Description
Cardiovascular training (CT) will be performed on a recumbent stepper. CT will start at low intensity, and through a linear progression will reach vigorous intensity; then, this intensity will be maintained until the end of the intervention. Each session will include five minutes of warm-up and cool-down performed at the beginning and the end of the training, respectively. Furthermore, five minutes of stretching will be performed after the cool down. CT's sessions will approximately last 45 minutes and will be interspersed with at least 48 hours of recovery.
Arm Title
Resistance training
Arm Type
Experimental
Arm Description
Resistance training (RT) intensity will be estimated using the percentage of one-maximal repetition (1-RM) defined as the maximal weight liftable for ten maximal repetitions with proper form. The program will include five exercises (leg press, lat machine, leg extension, leg curl, bench press) and will start at high-volume low-intensity. RT will follow a periodization to reach high-intensity low-volume at the end of the intervention (week 12). The training sessions will start with five-minute of warm-up performed on a recumbent stepper and will end with five-minute of stretching (cool-down). RT's sessions will approximately last 45 minutes and will be interspersed with at least 48 hours of recovery.
Intervention Type
Behavioral
Intervention Name(s)
CT
Intervention Description
12 weeks of exercise Cardiovascular Training
Intervention Type
Behavioral
Intervention Name(s)
RT
Intervention Description
12 weeks of exercise Resistance Training
Primary Outcome Measure Information:
Title
Sleep efficiency (SE)
Description
Actigraphy; SE = total sleep time/time spent in bed.
Time Frame
12 weeks
Title
Subjective sleep quality
Description
Parkinson's Disease Sleep Scale version 2 (PDSS-2); Score range from 0-60; higher scores represent worse sleep quality.
Time Frame
12 weeks
Title
Objective sleep measurements, including duration and percentage of sleep stages, total sleep time (TLT), wake after sleep onset (WASO), sleep latency (SL).
Description
Polysomnography combined with electroencephalogram
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Motor function
Description
Unified Parkinson's Disease Rating Scale part III; Scores range from 0-56; higher scores represent a worse motor function.
Time Frame
12 weeks
Title
Cognition
Description
Scale for Outcomes in Parkinson's Disease-Cognition; Scores range from 0-43; higher scores reflect better performance.
Time Frame
12 weeks
Title
Fatigue
Description
Parkinson's Disease Fatigue Scale; Scores range from 16-80; higher scores reflect a higher presence of fatigue.
Time Frame
12 weeks
Title
Psychosocial functioning
Description
Scale for Outcomes in Parkinson's Disease-Psychosocial; Scores range from 0-33; higher scores reflect a worse psychosocial functioning.
Time Frame
12 weeks
Title
Quality of life-related aspects in Parkinson's disease
Description
Parkinson's Disease Quality of Life Scale; Scores range from 0-128; higher scores indicate lower quality of life.
Time Frame
12 weeks
Title
Motor learning
Description
Visuomotor tracking task; accuracy in performing a novel motor task with the dominant hand.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Intra-cortical facilitation
Description
Paired-pulse of transcranial magnetic stimulation (TMS) protocol to estimate variation in cortical excitability measured as motor evoked potential (MEP).
Time Frame
12 weeks
Title
Short intra-cortical inhibition
Description
Paired-pulse of transcranial magnetic stimulation (TMS) protocol to estimate variation in cortical excitability measured as motor evoked potential (MEP).
Time Frame
12 weeks
Title
Silent period
Description
Paired-pulse of transcranial magnetic stimulation (TMS) protocol to estimate variation in cortical excitability measured as length of the pause in electromyographic activity.
Time Frame
12 weeks
Title
Cardiorespiratory fitness
Description
Maximum rate of oxygen consumption measured during maximum physical effort.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Roig, PhD
Phone
514-398-4400
Ext
00841
Email
marc.roigpull@mcgill.ca
Facility Information:
Facility Name
Jewish Rehabiliation Hospital
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7V 1R2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Roig, PhD
Phone
450-688-9550
Ext
4677
Email
marc.roigpull@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Josephine Salib, MSc
Phone
450-688-9550
Ext
4217

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results will be published in peer-review journals.

Learn more about this trial

Exercise and Sleep in Parkinson's Disease

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