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Exercise to Improve Sleep in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cardiovascular training (CT)
Resistance training (RT)
Multimodal training (MT)
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, Sleep, Exercise, Cardiovascular training, Resistance training, Multimodal training, Motor function, Cognition, Quality of life

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; 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.

Sites / Locations

  • Jewish Rehabilitation HospitalRecruiting
  • Human Brain Control of Locomotion LaboratoryRecruiting
  • Cummings Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Cardiovascular training (CT)

Resistance training (RT)

Multimodal training (MT)

Control condition (CON; waiting list)

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 training period. Each session will include five minutes of warm-up and cool-down performed at the beginning and at the end of the training, respectively. Furthermore, five minutes of stretching will be performed after the cool-down. CT's sessions will last approximately 45 minutes (30 to 50 minutes) and will be interspersed with 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 and end with five-minute of warm-up and cool-down, which will include exercise on a recumbent stepper and stretching, respectively. RT's sessions will last approximately 45 minutes (40 to 50 minutes) and will be interspersed with 48 hours of recovery.

Multimodal training (MT) will combine cardiovascular and resistance training interventions using the modalities described previously, but each component will be shortened to match the overall training duration (i.e., volume) among groups. The first part of each training session will always include three resistance exercises, which will be followed by 15-20 minutes of cardiovascular training performed on the total body recumbent stepper. Periodization will follow the same progression previously described for cardiovascular and resistance training, respectively, reaching vigorous intensity towards the end of the training period. Training sessions will include a five-minute warm-up and cool-down on the total body recumbent stepper. MT's sessions will approximately last 45 minutes (40 to 50 minutes) and will be interspersed with 48 hours of recovery.

The control condition (CON; waiting list) will receive no intervention (i.e., exercise) but usual care. Participants in the CON will be required to go about their normal life, maintaining their current physical activity levels until the end of the study. Then, they will be offered to join one of the training programs/condition.

Outcomes

Primary Outcome Measures

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 architectures
Changes in slow-wave power measured with polysomnography.
Changes in sleep architectures
Changes in sleep spindles density measured with polysomnography.
Changes in sleep architectures
Changes in REM sleep duration (%) measured with polysomnography.

Secondary Outcome Measures

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.
Changes in Quality of Life Scale
PD Quality of Life Scale (PDQUALIF); values = 0-100%; higher values (%) reflect worse quality of life.

Full Information

First Posted
November 18, 2022
Last Updated
December 8, 2022
Sponsor
McGill University
Collaborators
Jewish Rehabilitation Hospital, The Memory Lab, The Human Brain Control of Locomotion Lab (HBCL), The Cummings Centre, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT05644327
Brief Title
Exercise to Improve Sleep in Parkinson's Disease
Official Title
The Effects of Different Exercise Modalities on Sleep Quality and Architecture in People With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 1, 2026 (Anticipated)
Study Completion Date
September 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University
Collaborators
Jewish Rehabilitation Hospital, The Memory Lab, The Human Brain Control of Locomotion Lab (HBCL), The Cummings Centre, Canadian Institutes of Health Research (CIHR)

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 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.
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. Almost all (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 are clinically relevant as they have been associated with a 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 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, RT, MT, and CON 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 exercise modality, positive changes in sleep quality and architecture mediate exercise-induced improvements in aspects directly related to QoL such as cognitive and motor function. Design: A four-arm, parallel-group, multi-site, single-blinded RCT with assessments performed at baseline (T0) and after 12 weeks of training (T1), as well as at 8 weeks post-intervention (T2), by assessors blinded to the participants' group allocation. Methods: After completing T0, participants will be randomly allocated into four groups using a sequence created and held by a central randomization service (https://www.randomizer.at) using a 1:1:1:1 ratio. Permuted blocks of varying sizes to ensure balance over time will be used. Adherence to the training programs and training intensity progression will be monitored by trainers who will track attendance and record responses to exercise (e.g., HR) during training sessions. Participants who will miss training sessions due to valid reasons (e.g., doctor appointments) will be offered make-up sessions to complete the full 36 training sessions. Participants who do not complete 80% of the training (>27 training sessions) over the 12-week, develop injuries that preclude safety during training, or desire to stop the program, will be excluded. Changes in objective and subjective measures of sleep quality will be assessed with polysomnography 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 part III 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. The plasma concentration of different inflammatory biomarkers will be assessed using enzyme-linked immunosorbent assays (ELISA) kits following the instructions provided by the manufacturers. Cardiorespiratory fitness will be assessed with a graded exercise test (GXT) performed on a recumbent stepper. Expected results: 1) MT will be more effective than RT, CT, and CON at improving objective and subjective sleep quality and sleep architecture; 2) Sleep architecture improvements, regardless of the type of exercise performed, will mediate enhancements in cognition and motor function; 3) Improvements in sleep quality (i.e., sleep efficiency), regardless of the type of exercise performed, will mediate enhancements in different QoL-related aspects such as fatigue and psychological functioning. Impact: This will be the first study comparing the effect of MT, CT and RT on sleep quality and architecture and investigating whether these changes mediate improvements in cognitive and motor function as well as QoL-related aspects (e.g., fatigue). The results of the study will provide important information to design more personalized exercise-based treatments, which are patient-oriented and aimed at optimizing the effect of sleep on cognitive and motor function as well as QoL in PD.

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, Sleep, Exercise, Cardiovascular training, Resistance training, Multimodal training, Motor function, Cognition, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Assessors will be blinded to the participants' group allocation
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiovascular training (CT)
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 training period. Each session will include five minutes of warm-up and cool-down performed at the beginning and at the end of the training, respectively. Furthermore, five minutes of stretching will be performed after the cool-down. CT's sessions will last approximately 45 minutes (30 to 50 minutes) and will be interspersed with 48 hours of recovery.
Arm Title
Resistance training (RT)
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 and end with five-minute of warm-up and cool-down, which will include exercise on a recumbent stepper and stretching, respectively. RT's sessions will last approximately 45 minutes (40 to 50 minutes) and will be interspersed with 48 hours of recovery.
Arm Title
Multimodal training (MT)
Arm Type
Experimental
Arm Description
Multimodal training (MT) will combine cardiovascular and resistance training interventions using the modalities described previously, but each component will be shortened to match the overall training duration (i.e., volume) among groups. The first part of each training session will always include three resistance exercises, which will be followed by 15-20 minutes of cardiovascular training performed on the total body recumbent stepper. Periodization will follow the same progression previously described for cardiovascular and resistance training, respectively, reaching vigorous intensity towards the end of the training period. Training sessions will include a five-minute warm-up and cool-down on the total body recumbent stepper. MT's sessions will approximately last 45 minutes (40 to 50 minutes) and will be interspersed with 48 hours of recovery.
Arm Title
Control condition (CON; waiting list)
Arm Type
No Intervention
Arm Description
The control condition (CON; waiting list) will receive no intervention (i.e., exercise) but usual care. Participants in the CON will be required to go about their normal life, maintaining their current physical activity levels until the end of the study. Then, they will be offered to join one of the training programs/condition.
Intervention Type
Behavioral
Intervention Name(s)
Cardiovascular training (CT)
Intervention Description
12 weeks of CT
Intervention Type
Behavioral
Intervention Name(s)
Resistance training (RT)
Intervention Description
12 weeks of RT
Intervention Type
Behavioral
Intervention Name(s)
Multimodal training (MT)
Intervention Description
12 weeks of MT
Primary Outcome Measure Information:
Title
Changes in objective sleep quality
Description
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)
Title
Changes in subjective sleep quality
Description
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)
Title
Changes in sleep architectures
Description
Changes in slow-wave power measured with polysomnography.
Time Frame
12 weeks (post-intervention) and 8 weeks (follow-up)
Title
Changes in sleep architectures
Description
Changes in sleep spindles density measured with polysomnography.
Time Frame
12 weeks (post-intervention) and 8 weeks (follow-up)
Title
Changes in sleep architectures
Description
Changes in REM sleep duration (%) measured with polysomnography.
Time Frame
12 weeks (post-intervention) and 8 weeks (follow-up)
Secondary Outcome Measure Information:
Title
Changes in motor function
Description
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)
Title
Changes in cognitive function
Description
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)
Title
Changes in fatigue
Description
PD Fatigue Scale; values = 16-80; higher values reflect worse fatigue.
Time Frame
12 weeks (post-intervention) and 8 weeks (follow-up)
Title
Changes in psychosocial functioning
Description
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)
Title
Changes in Quality of Life Scale
Description
PD Quality of Life Scale (PDQUALIF); values = 0-100%; higher values (%) reflect worse quality of life.
Time Frame
12 weeks (post-intervention) and 8 weeks (follow-up)
Other Pre-specified Outcome Measures:
Title
Inflammatory biomarkers
Description
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)
Title
Cardiorespiratory fitness
Description
VO2 peak measured during a Graded Exercise Test (GXT)
Time Frame
12 weeks (post-intervention) and 8 weeks (follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Roig, Ph.D.
Phone
514-398-4400
Ext
84599
Email
marc.roigpull@mcgill.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Paquette, Ph.D.
Phone
514-398-4400
Ext
00890
Email
caroline.paquette@mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Roig, Ph.D.
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish Rehabilitation 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, Ph.D.
Phone
450-688-9550
Ext
84599
Email
marc.roigpull@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Jacopo Cristini, MSc
Phone
450-688-9550
Ext
84416
Email
jacopo.cristini@mail.mcgill.ca
Facility Name
Human Brain Control of Locomotion Laboratory
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W 1S4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Paquette, Ph.D.
Phone
514-398-4400
Ext
00890
Email
caroline.paquette@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Alexandra Potvin-Desrochers, Ph.D.
Phone
514-398-4184
Ext
09833
Email
alexandra.potvin-desrochers@mail.mcgill.ca
Facility Name
Cummings Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3W 3E8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Fragapane
Phone
514.734.1797
Email
maria.fragapane@cummingscentre.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise to Improve Sleep in Parkinson's Disease

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