Recruiting

Exercise & Sleep

Sponsor:

McGill University

Code:

NCT04558879

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

CT

RT

Study Details

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.

Conditions

Parkinson Disease

Study ID

NCT04558879

Start date

Sep 15, 2021

Status verified date

Mar, 2024

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cardiovascular training

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.

experimental: Resistance training

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.

Interventions

CT

12 weeks of exercise Cardiovascular Training

RT

12 weeks of exercise Resistance Training

Primary outcome measure

  • Sleep efficiency (SE) [ Time Frame: 12 weeks ]
  • Subjective sleep quality [ Time Frame: 12 weeks ]
  • 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 ]

Central Contacts and Locations

Central contacts

Marc Roig, PhD

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

Locations

Jewish Rehabiliation Hospital

Recruiting

Laval, Quebec, Canada, H7V 1R2

Contacts

Marc Roig, PhD

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

Josephine Salib, MSc

450-688-9550

More Information

Sponsor

McGill University

Last update posted

Mar 15, 2024

Last verified

Mar, 2024

Keywords

  • Parkinson's disease
  • Rehabilitation
  • Neurosciences
  • Sleep
  • Exercise
  • Cardiovascular training
  • Resistance training
  • Cognition
  • Motor function
  • 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 2024-03-15.