What is the mechanism of action of this treatment?

Common treatments for Parkinson's Disease (PD) include pharmacologic therapies like levodopa, dopamine agonists, and MAO-B inhibitors, which work by replenishing or mimicking dopamine to alleviate motor symptoms. Nonpharmacologic treatments, such as cardiovascular, resistance, and multimodal exercise, are also essential. These exercises improve sleep quality and architecture, which is crucial for PD patients as poor sleep can worsen both motor and nonmotor symptoms, thereby enhancing overall quality of life. Additionally, exercise promotes neuroplasticity, potentially slowing the progression of the disease.

What side effects are associated with this type of intervention?

Exercise modalities such as cardiovascular, resistance, and multimodal training are generally well-tolerated in Parkinson's Disease, with minimal side effects like muscle soreness or fatigue. Pharmacological treatments, including dopamine agonists, can cause nausea, dizziness, hallucinations, and impulse control disorders, while long-term use of levodopa may lead to motor fluctuations and dyskinesias. Nonpharmacologic approaches like cognitive behavioral therapy and bright light therapy are also well-tolerated, with few adverse effects.

What prior FDA approvals exist?

FDA-approved treatments for Parkinson's Disease primarily include pharmacologic agents such as levodopa, dopamine agonists (e.g., pramipexole, ropinirole), MAO-B inhibitors (e.g., selegiline, rasagiline), and amantadine. These medications aim to manage motor symptoms and improve quality of life. While exercise modalities like cardiovascular, resistance, and multimodal training are not FDA-approved treatments, they are being studied for their potential to improve sleep quality and overall quality of life in PD patients, similar to the benefits seen with pharmacologic treatments.

What other types of research exist?

Promising, novel alternatives to traditional exercise modalities for Parkinson's Disease patients include tai chi, virtual reality (VR) training, and cognitive behavioral therapy for insomnia (CBT-I). These interventions have demonstrated improvements in balance, motor function, walking distance, and sleep quality, potentially enhancing the overall quality of life for PD patients.

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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

Summary

This trial will test if different types of exercise can improve sleep and quality of life in people with Parkinson's disease. Participants will do cardiovascular, resistance, or combined exercises for a few months. The study aims to see if better sleep leads to better movement, thinking, and overall well-being.

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.

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.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks (post-intervention) and 8 weeks (follow-up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in objective sleep quality

Changes in sleep architectures

Changes in subjective sleep quality

Secondary study objectives

Changes in Quality of Life Scale

Changes in cognitive function

Changes in fatigue

+2 more

Other study objectives

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Parkinson's Disease (PD) include pharmacologic therapies like levodopa, dopamine agonists, and MAO-B inhibitors, which work by replenishing or mimicking dopamine to alleviate motor symptoms. Nonpharmacologic treatments, such as cardiovascular, resistance, and multimodal exercise, are also essential. These exercises improve sleep quality and architecture, which is crucial for PD patients as poor sleep can worsen both motor and nonmotor symptoms, thereby enhancing overall quality of life. Additionally, exercise promotes neuroplasticity, potentially slowing the progression of the disease.

Current Management and Emerging Therapies in Multiple System Atrophy.

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Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,373 Previous Clinical Trials

26,519,092 Total Patients Enrolled

The Memory LabUNKNOWN

McGill UniversityLead Sponsor

403 Previous Clinical Trials

1,017,909 Total Patients Enrolled

Media Library

Cardiovascular training (CT) Clinical Trial Eligibility Overview. Trial Name: NCT05644327 — N/A

Parkinson's Disease Research Study Groups: Multimodal training (MT), Cardiovascular training (CT), Control condition (CON; waiting list), Resistance training (RT)

Parkinson's Disease Clinical Trial 2023: Cardiovascular training (CT) Highlights & Side Effects. Trial Name: NCT05644327 — N/A

Cardiovascular training (CT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05644327 — N/A

~62 spots leftby Dec 2026

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