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Exercise for Parkinson's Disease
N/A
Recruiting
Led By Marc Roig, Ph.D.
Research Sponsored by McGill University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks (post-intervention) and 8 weeks (follow-up)
Awards & highlights
Study Summary
This trial will look at how exercise affects sleep in people with Parkinson's and its effect on quality of life. 4 groups of participants will exercise 3x/week for 12 weeks and be assessed at baseline and post-intervention.
Who is the study for?
This trial is for people with mild to moderate Parkinson's Disease who have poor sleep quality. They must be on a stable medication dose and not have severe cognitive or mental health issues, untreated sleep apnea, osteoporosis, or other neurological conditions. They shouldn't already be very active or in another exercise/drug study.Check my eligibility
What is being tested?
The study tests how cardiovascular training (CT), resistance training (RT), and multimodal training (MT) affect sleep and life quality in Parkinson's patients over 12 weeks. Participants will train three times a week and are compared to a control group on a waiting list.See study design
What are the potential side effects?
Exercise programs may cause muscle soreness, fatigue, joint pain, or increase the risk of falls especially if balance is affected by Parkinson’s disease. However, these side effects vary from person to person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks (post-intervention) and 8 weeks (follow-up)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks (post-intervention) and 8 weeks (follow-up)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in objective sleep quality
Changes in sleep architectures
Changes in subjective sleep quality
Secondary outcome measures
Changes in Quality of Life Scale
Changes in cognitive function
Changes in fatigue
+2 moreOther outcome measures
Cardiorespiratory fitness
Inflammatory biomarkers
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Resistance training (RT)Experimental Treatment1 Intervention
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.
Group II: Multimodal training (MT)Experimental Treatment1 Intervention
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.
Group III: Cardiovascular training (CT)Experimental Treatment1 Intervention
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.
Group IV: Control condition (CON; waiting list)Active Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resistance training (RT)
2018
Completed Phase 3
~170
Find a Location
Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,348 Previous Clinical Trials
26,455,435 Total Patients Enrolled
The Memory LabUNKNOWN
McGill UniversityLead Sponsor
397 Previous Clinical Trials
1,000,118 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My medication dose has been the same for the last month.I have Parkinson's Disease at a mild to moderate stage.I have severe osteoporosis.I have a neurological condition like atypical parkinsonism, dementia, or stroke.I have severe sleep apnea that hasn't been treated.I am not part of any other exercise or drug trials.My Parkinson's Disease is in the early to mid stages.My medication dose has been the same for the last month.I often have trouble sleeping well.
Research Study Groups:
This trial has the following groups:- Group 1: Multimodal training (MT)
- Group 2: Cardiovascular training (CT)
- Group 3: Control condition (CON; waiting list)
- Group 4: Resistance training (RT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any ongoing recruiting efforts for this investigative trial?
"Data on clinicaltrials.gov confirms that this experiment has launched its recruitment phase, with the initial post date being September 1st 2021 and the last edit taking place in December 8th 2022."
Answered by AI
Could you provide an estimate of the number of participants involved in this experiment?
"Affirmative. Per the information found on clinicaltrials.gov, this research trial is currently seeking participants to join. It was first announced on September 1st 2021 and its most recent update occurred December 8th 2022. There are 150 positions open between 3 different medical facilities."
Answered by AI
What does this investigation seek to accomplish?
"This medical trial spans 12 weeks post-intervention and 8 weeks of follow up, with the primary objective of evaluating changes in sleep quality. Additionally, secondary outcomes include assessing Quality of Life Scale (PDQUALIF), cognitive function via SCOPA-COG, and fatigue based on the PD Fatigue Scale."
Answered by AI
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