Exercise for Parkinson's Disease

Recruiting at 4 trial locations

Overseen By Marc Roig, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGill University

Disqualifiers: Atypical parkinsonism, Dementia, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 36

Duration: 12 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of exercise can improve sleep and quality of life for people with Parkinson's disease. Participants will engage in cardiovascular training (CT), resistance training (RT), a combination of both known as multimodal training (MT), or join a control group with no new exercise routine. The goal is to determine if these exercises alleviate sleep problems, which are common in Parkinson's. Ideal candidates are those with Parkinson's who experience sleep difficulties and are not already participating in extensive exercise routines. As an unphased trial, this study provides a unique opportunity to contribute to understanding how exercise can enhance sleep and quality of life for those with Parkinson's.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you have been on a stable dosage of medication for the past month.

What prior data suggests that these exercise modalities are safe for individuals with Parkinson's disease?

Studies have shown that exercise is generally safe and beneficial for people with Parkinson's disease (PD). Research indicates that multimodal training (MT), which combines various exercises, effectively manages PD symptoms. It improves movement and quality of life without major safety concerns.

Cardiovascular training (CT), including activities like walking or cycling, is also safe for people with PD. This aerobic exercise can reduce the risk of heart disease and aid movement. Studies have not reported any major safety issues for this exercise in people with PD.

Resistance training (RT), involving lifting weights or using resistance bands, enhances muscle strength and movement in people with PD. Research shows that moderate-intensity resistance training is well-tolerated, with no major side effects reported.

Overall, these types of exercise are both safe and beneficial for people with Parkinson's. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these exercise programs for Parkinson's disease because they offer a non-drug approach that could improve symptoms. Unlike medications that primarily aim to manage symptoms, these exercise routines—cardiovascular, resistance, and multimodal training—are designed to enhance physical function and possibly slow disease progression. Cardiovascular training focuses on heart health and endurance, resistance training builds muscle strength, and multimodal training combines both for a comprehensive workout. This holistic approach could offer a new avenue for managing Parkinson's, with the potential for fewer side effects compared to traditional drug treatments.

What evidence suggests that this trial's exercise treatments could be effective for Parkinson's disease?

Research has shown that different types of exercise can help people with Parkinson's disease (PD). In this trial, participants will follow various exercise regimens. Cardiovascular training (CT), which includes aerobic exercises like walking or cycling, improves balance, walking, and movement. Resistance training (RT), focusing on strength exercises, strengthens muscles and aids balance and walking. Multimodal training (MT), combining aerobic and strength exercises, enhances walking ability, movement, and strength. These exercises may also improve quality of life and address sleep issues, which often affect people with PD. Overall, these exercise methods offer promising benefits for managing PD symptoms. ^{2 6 7 8 9}

Who Is on the Research Team?

Marc Roig, Ph.D.

Principal Investigator

McGill University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My medication dose has been the same for the last month.

Having poor sleep quality defined as a score > 15 in the PDSS-2

My Parkinson's Disease is in the early to mid stages.

Exclusion Criteria

Having absolute contraindications to exercise

Having a Beck Depression Inventory score >31

I have severe osteoporosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform either cardiovascular training, resistance training, multimodal training, or are allocated to a control condition for 12 weeks. Training is performed three times per week.

12 weeks

36 sessions (in-person)

Follow-up

Participants are monitored for changes in sleep quality, cognitive function, and quality of life 8 weeks after the intervention.

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cardiovascular training (CT)
• Multimodal training (MT)
• Resistance training (RT)

Trial Overview

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.

How Is the Trial Designed?

Group I: Resistance training (RT) Experimental Treatment 1 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 Treatment 1 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 Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

The Memory Lab

Collaborator

Trials

1

Recruited

150+

Jewish Rehabilitation Hospital

Collaborator

Trials

7

Recruited

810+

The Human Brain Control of Locomotion Lab (HBCL)

Collaborator

Trials

1

Recruited

150+

The Cummings Centre

Collaborator

Trials

1

Recruited

150+

Published Research Related to This Trial

Resistance training (RT) and endurance training (ET) are safe and feasible exercise modalities for people with Parkinson's disease, showing significant benefits in muscle strength, functional capacity, and quality of life based on a review of 33 new randomized controlled trials.

RT demonstrated a strong positive impact on muscle strength (SMD = 0.83) and functional capacity, while ET improved cardiorespiratory fitness (SMD = 0.27) and also showed potential benefits for functional outcomes, indicating that both types of exercise can be effective adjunct therapies for managing Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parkinson's disease and intensive exercise therapy - An updated systematic review and meta-analysis. Gamborg, M., Hvid, LG., Dalgas, U., et al.[2022]

A network meta-analysis of 20 trials involving 719 patients with Parkinson's disease found that short periods of high-intensity resistance training significantly improved motor symptoms, as measured by the Unified Parkinson's Disease Motor Rating Scale (UPDRS III).

Both aerobic and resistance training at varying intensities showed efficacy in improving motor symptoms and quality of life in Parkinson's patients, suggesting that exercise prescriptions should include these modalities, although further high-quality studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of aerobic and resistance training on the motor symptoms in Parkinson's disease: Systematic review and network meta-analysis. Zhou, X., Zhao, P., Guo, X., et al.[2023]

A tablet-based training program for Parkinson's disease patients was successfully tested over 9 months, helping them stay motivated and develop personalized training routines after inpatient treatment.

Patients reported positive aspects such as structured support and Parkinson's specificity, but also suggested improvements for better individualization and flexibility in training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Implementation of an individualized tablet-based training program in the domestic setting following complex treatment of Parkinson's disease-Success factors and barriers]. Wagner, L., Deck, R.[2022]

An 8-week resistance training program significantly improved maximum leg press strength relative to body mass in 18 individuals with Parkinson's disease, indicating enhanced lower-body strength (P < .05).

The training involved moderate volume, high-load exercises performed twice weekly, demonstrating that this type of resistance training can be beneficial for strength and function in people with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of moderate-volume, high-load lower-body resistance training on strength and function in persons with Parkinson's disease: a pilot study. Schilling, BK., Pfeiffer, RF., Ledoux, MS., et al.[2021]

The article provides evidence-based exercise guidelines for individuals with multiple sclerosis, stroke, and Parkinson disease, emphasizing the importance of both aerobic and resistance training.

For multiple sclerosis, the recommended regimen is 2-3 days per week of aerobic training (10-30 minutes at moderate intensity) and 2-3 days of resistance training (1-3 sets of 8-15 repetitions). Stroke guidelines suggest 3-5 days of aerobic training (20-40 minutes) and similar resistance training, while Parkinson disease guidelines recommend 3-5 days of aerobic training (20-60 minutes) and resistance training (1-3 sets of 8-12 repetitions).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training Guidelines for Multiple Sclerosis, Stroke, and Parkinson Disease: Rapid Review and Synthesis. Kim, Y., Lai, B., Mehta, T., et al.[2023]

Resistance training (RT) significantly improves muscle strength, motor impairment, mobility, balance, and quality of life in patients with Parkinson's disease, based on a meta-analysis of 18 randomized controlled trials.

While RT shows large effects compared to passive control groups, it does not demonstrate superior benefits over other physically active interventions, suggesting that any form of exercise is beneficial for Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Resistance Training on Motor- and Non-Motor Symptoms in Patients with Parkinson's Disease: A Systematic Review and Meta-Analysis. Gollan, R., Ernst, M., Lieker, E., et al.[2022]

Combining resistance training with aerobic training (CT) significantly improves physical function outcomes, such as peak oxygen uptake and muscular strength, compared to aerobic training alone (AT), based on a systematic review of multiple studies.

Shorter duration CT interventions are particularly effective for enhancing physical function, suggesting that they may help patients with coronary heart disease return to daily activities more quickly, although more high-quality research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing resistance training in the rehabilitation of coronary heart disease: A systematic review and meta-analysis. Xanthos, PD., Gordon, BA., Kingsley, MI.[2022]

Both Tai Chi and combined stretching-strengthening exercises improved functional fitness in patients with mild-to-moderate Parkinson's disease after 8 weeks of training, compared to a control group that showed deterioration.

Tai Chi specifically enhanced the emotional quality of life for participants, while the combined stretching-strengthening exercise improved social quality of life, indicating that Tai Chi may be a particularly beneficial exercise strategy for improving overall well-being in Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Exercise Programs for Parkinson's Disease: Tai Chi versus Combined Exercise. Cheon, SM., Chae, BK., Sung, HR., et al.[2021]

Resistance Training (RT) is shown to significantly improve muscle strength in individuals with Parkinson's Disease, with a moderate effect size based on a meta-analysis of 15 randomized controlled trials.

All three exercise modalities—Resistance Training, Endurance Training, and Other Intensive Training Modalities—are safe and feasible, potentially benefiting balance, walking performance, and quality of life in Parkinson's Disease, with no reported deterioration in outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parkinson's disease and intensive exercise therapy--a systematic review and meta-analysis of randomized controlled trials. Uhrbrand, A., Stenager, E., Pedersen, MS., et al.[2018]

Resistance training (RT) significantly improves knee extension, knee flexion, and leg press strength in people with Parkinson's disease compared to control groups, based on a systematic review of nine studies.

Combining RT with other forms of exercise, such as aerobic or balance training, leads to even greater improvements in strength, although RT alone may not always outperform other exercise types for certain muscle groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Resistance Training on Measures of Muscular Strength in People with Parkinson's Disease: A Systematic Review and Meta-Analysis. Roeder, L., Costello, JT., Smith, SS., et al.[2018]

Combined endurance-resistance training (CT) significantly improved submaximal exercise capacity and upper limb strength in chronic heart failure (CHF) patients compared to endurance training (ET) alone, with 60% of CT patients reporting reduced cardiac symptoms.

CT did not negatively affect left ventricular function or overall outcomes, suggesting it is a safe and effective training method for enhancing quality of life in CHF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined endurance-resistance training vs. endurance training in patients with chronic heart failure: a prospective randomized study. Beckers, PJ., Denollet, J., Possemiers, NM., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9622812/

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pmc.ncbi.nlm.nih.gov

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Cardiopulmonary Function and Aerobic Exercise in Parkinson's

In general, aerobic exercise was found to have positive effects on cardiac function for people with Parkinson's, but there is a lack of studies on the effects ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S1878747923012503

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frontiersin.org

frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2022.935176/full

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thelancet.com

thelancet.com/journals/laneur/article/PIIS1474-4422(19)30285-6/fulltext

a double-blind, randomised controlled trial

High-intensity aerobic exercise might attenuate the symptoms of Parkinson's disease, but high-quality evidence is scarce.

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sciencedirect.com

sciencedirect.com/org/science/article/pii/S1874434619000345

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clinicaltrials.gov/study/NCT00784563

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In the third year, all participants were assigned to the continuous arm after preliminary analyses of prior data raised safety concerns about interval training.

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Exercise as medicine in Parkinson's disease

Exercise is safe and represents a cornerstone in PD rehabilitation, but exercise may have even more fundamental benefits that could change clinical practice.