Recruiting

CT, RT, MT

Sponsor:

McGill University

Code:

NCT05644327

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Cardiovascular training (CT)

Resistance training (RT)

Multimodal training (MT)

Study Details

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

Study ID

NCT05644327

Start date

Sep 1, 2021

Status verified date

Mar, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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 and/or reporting subjective sleep complaints affecting their sleep quality;

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cardiovascular training (CT)

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.

experimental: Resistance training (RT)

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.

experimental: Multimodal training (MT)

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.

no intervention: Control condition (CON; waiting list)

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)

12 weeks of CT

Resistance training (RT)

12 weeks of RT

Multimodal training (MT)

12 weeks of MT

Primary outcome measure

  • Changes in objective sleep quality [ Time Frame: 12 weeks (post-intervention) and 8 weeks (follow-up) ]
  • Changes in subjective sleep quality [ Time Frame: 12 weeks (post-intervention) and 8 weeks (follow-up) ]
  • Changes in sleep architecture [ Time Frame: 12 weeks (post-intervention) and 8 weeks (follow-up) ]
  • Changes in sleep architecture [ Time Frame: 12 weeks (post-intervention) and 8 weeks (follow-up) ]
  • Changes in sleep architectures [ Time Frame: 12 weeks (post-intervention) and 8 weeks (follow-up) ]

Central Contacts and Locations

Central contacts

Marc Roig, Ph.D.

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

Caroline Paquette, Ph.D.

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

Locations

Jewish Rehabilitation Hospital

Recruiting

Laval, Quebec, Canada, H7V 1R2

Contacts

Marc Roig, Ph.D.

450-688-9550marc.roigpull@mcgill.ca

Jacopo Cristini, MSc

450-688-9550jacopo.cristini@mail.mcgill.ca

Human Brain Control of Locomotion Laboratory

Recruiting

Montreal, Quebec, Canada, H2W 1S4

Contacts

Caroline Paquette, Ph.D.

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

Alexandra Potvin-Desrochers, Ph.D.

514-398-4184alexandra.potvin-desrochers@mail.mcgill.ca

More Information

Sponsor

McGill University

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University on 2026-03-13.