Exercise to Improve Sleep in Parkinson's Disease

NCT05644327 | Recruiting

• 1 other identifier: MP5020221584
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; Rehabilitation; Sleep; Exercise; Cardiovascular training; Resistance training; Multimodal training; Motor function; Cognition; Quality of life

Outcome Measures

Primary Outcomes (5)

• 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.

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

• Changes in subjective sleep quality

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

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

• Changes in sleep architecture

  Changes in slow-wave power measured with polysomnography.

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

• Changes in sleep architecture

  Changes in sleep spindles density measured with polysomnography.

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

• Changes in sleep architectures

  Changes in REM sleep duration (%) measured with polysomnography.

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

Secondary Outcomes (5)

• Changes in motor function

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

• Changes in cognitive function

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

• Changes in fatigue

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

• Changes in psychosocial functioning

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

• Changes in Quality of Life Scale

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

Other Outcomes (2)

• Inflammatory biomarkers

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

• Cardiorespiratory fitness

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

Study Arms (4)

Cardiovascular training (CT)

EXPERIMENTAL

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.

Behavioral: Cardiovascular training (CT)

Resistance training (RT)

EXPERIMENTAL

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.

Behavioral: Resistance training (RT)

Multimodal training (MT)

EXPERIMENTAL

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.

Behavioral: Multimodal training (MT)

Control condition (CON; waiting list)

NO INTERVENTION

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.

Interventions

Cardiovascular training (CT) BEHAVIORAL

12 weeks of CT

Cardiovascular training (CT)

Resistance training (RT) BEHAVIORAL

12 weeks of RT

Resistance training (RT)

Multimodal training (MT) BEHAVIORAL

12 weeks of MT

Multimodal training (MT)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jewish Rehabilitation Hospital: collaborator
• McGill University: lead
• The Memory Lab: collaborator
• The Human Brain Control of Locomotion Lab (HBCL): collaborator
• The Cummings Centre: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (3)

Jewish Rehabilitation Hospital

Laval, Quebec, H7V 1R2, Canada

RECRUITING

Human Brain Control of Locomotion Laboratory

Montreal, Quebec, H2W 1S4, Canada

RECRUITING

Cummings Centre

Montreal, Quebec, H3W 3E8, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marc Roig, Ph.D.

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Roig, Ph.D.

CONTACT

514-398-4400; marc.roigpull@mcgill.ca

Caroline Paquette, Ph.D.

CONTACT

514-398-4400; caroline.paquette@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Assessors will be blinded to the participants' group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 9, 2022
• Study Start: September 1, 2021
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)