## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** 35450
#### Organization
**Class:** OTHER
**Full Name:** McGill University
### Status Module
#### Completion Date
**Date:** 2025-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-15

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-09-15

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2020-09-22
**Type:** ACTUAL
**Study First Submit Date:** 2020-09-09
**Study First Submit QC Date:** 2020-09-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Jewish Rehabilitation Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** McGill University

#### Responsible Party

**Investigator Affiliation:** McGill University

**Investigator Full Name:** Marc Roig

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Parkinson Disease

**Keywords:**

- Parkinson's disease

- Rehabilitation

- Neurosciences

- Sleep

- Exercise

- Cardiovascular training

- Resistance training

- Cognition

- Motor function

- Quality of life

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Behavioral: CT

**Label:** Cardiovascular training

**Type:** EXPERIMENTAL

#### Arm Group 2

**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 Names:**

- Behavioral: RT

**Label:** Resistance training

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cardiovascular training

**Description:** 12 weeks of exercise Cardiovascular Training

**Name:** CT

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Resistance training

**Description:** 12 weeks of exercise Resistance Training

**Name:** RT

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** Paired-pulse of transcranial magnetic stimulation (TMS) protocol to estimate variation in cortical excitability measured as motor evoked potential (MEP).

**Measure:** Intra-cortical facilitation

**Time Frame:** 12 weeks

**Description:** Paired-pulse of transcranial magnetic stimulation (TMS) protocol to estimate variation in cortical excitability measured as motor evoked potential (MEP).

**Measure:** Short intra-cortical inhibition

**Time Frame:** 12 weeks

**Description:** Paired-pulse of transcranial magnetic stimulation (TMS) protocol to estimate variation in cortical excitability measured as length of the pause in electromyographic activity.

**Measure:** Silent period

**Time Frame:** 12 weeks

**Description:** Maximum rate of oxygen consumption measured during maximum physical effort.

**Measure:** Cardiorespiratory fitness

**Time Frame:** 12 weeks

#### Primary Outcomes

**Description:** Actigraphy; SE = total sleep time/time spent in bed.

**Measure:** Sleep efficiency (SE)

**Time Frame:** 12 weeks

**Description:** Parkinson's Disease Sleep Scale version 2 (PDSS-2); Score range from 0-60; higher scores represent worse sleep quality.

**Measure:** Subjective sleep quality

**Time Frame:** 12 weeks

**Description:** Polysomnography combined with electroencephalogram

**Measure:** Objective sleep measurements, including duration and percentage of sleep stages, total sleep time (TLT), wake after sleep onset (WASO), sleep latency (SL).

**Time Frame:** 12 weeks

#### Secondary Outcomes

**Description:** Unified Parkinson's Disease Rating Scale part III; Scores range from 0-56; higher scores represent a worse motor function.

**Measure:** Motor function

**Time Frame:** 12 weeks

**Description:** Scale for Outcomes in Parkinson's Disease-Cognition; Scores range from 0-43; higher scores reflect better performance.

**Measure:** Cognition

**Time Frame:** 12 weeks

**Description:** Parkinson's Disease Fatigue Scale; Scores range from 16-80; higher scores reflect a higher presence of fatigue.

**Measure:** Fatigue

**Time Frame:** 12 weeks

**Description:** Scale for Outcomes in Parkinson's Disease-Psychosocial; Scores range from 0-33; higher scores reflect a worse psychosocial functioning.

**Measure:** Psychosocial functioning

**Time Frame:** 12 weeks

**Description:** Parkinson's Disease Quality of Life Scale; Scores range from 0-128; higher scores indicate lower quality of life.

**Measure:** Quality of life-related aspects in Parkinson's disease

**Time Frame:** 12 weeks

**Description:** Visuomotor tracking task; accuracy in performing a novel motor task with the dominant hand.

**Measure:** Motor learning

**Time Frame:** 12 weeks

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 45 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** marc.roigpull@mcgill.ca

**Name:** Marc Roig, PhD

**Phone:** 514-398-4400

**Phone Ext:** 00841

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Laval

**Contacts:**

***Contact 1:***

- **Email:** marc.roigpull@mcgill.ca

- **Name:** Marc Roig, PhD

- **Phone:** 450-688-9550

- **Phone Ext:** 4677

- **Role:** CONTACT

***Contact 2:***

- **Name:** Josephine Salib, MSc

- **Phone:** 450-688-9550

- **Phone Ext:** 4217

- **Role:** CONTACT

**Country:** Canada

**Facility:** Jewish Rehabiliation Hospital

**State:** Quebec

**Status:** RECRUITING

**Zip:** H7V 1R2

### IPD Sharing Statement Module

**Description:** Results will be published in peer-review journals.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020734

- Term: Parkinsonian Disorders

- ID: D000001480

- Term: Basal Ganglia Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009069

- Term: Movement Disorders

- ID: D000080874

- Term: Synucleinopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M13213

- Name: Parkinson Disease

- Relevance: HIGH

- As Found: Parkinson's Disease

- ID: M22494

- Name: Parkinsonian Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M25603

- Name: Ganglion Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M4774

- Name: Basal Ganglia Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12029

- Name: Movement Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M2217

- Name: Synucleinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010300

- Term: Parkinson Disease

### Misc Info Module

- Version Holder: 2024-05-24
