Exercise Therapy for Parkinson's Disease

Recruiting at 1 trial location

Overseen By Marc Roig, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGill University

Disqualifiers: Atypical parkinsonism, Dementia, Severe OSA, others

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

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how two exercise types—cardiovascular training (such as running) and resistance training (such as weight lifting)—affect sleep and overall well-being in people with Parkinson's disease. Researchers aim to determine if improved sleep from these exercises also enhances brain health and quality of life. Participants will engage in one type of exercise for 12 weeks, twice a week, with evaluations conducted before and after the program. This trial suits individuals with mild to moderate Parkinson's who experience sleep difficulties and maintain a stable medication routine. As an unphased trial, it offers a unique opportunity to contribute to understanding how exercise can improve life quality 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both cardiovascular and resistance exercises are generally safe for people with Parkinson's disease (PD). Aerobic exercises, including cardiovascular workouts, can improve balance, walking, and motor skills in individuals with PD. They also help lower the risk of heart disease and can increase life expectancy. Some research suggests that high-intensity aerobic exercise might protect brain cells that produce dopamine, which is important for movement.

Resistance training is also beneficial. Studies indicate it increases muscle strength and aids mobility. It can improve quality of life and help with issues like "freezing of gait," when someone feels stuck and unable to move.

Both types of exercise have been extensively studied and are well-tolerated. No major safety concerns have been reported for either type in people with Parkinson's disease. Participants usually manage these exercises well, making them a safe option for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring exercise therapy for Parkinson's Disease because it taps into the body's natural ability to improve its own function without medication. Unlike standard treatments that primarily rely on medication to manage symptoms, cardiovascular and resistance training focus on enhancing physical fitness, which could lead to improved mobility and strength. Cardiovascular training ramps up gradually to a vigorous intensity, potentially boosting heart health and endurance, while resistance training strengthens muscles through a systematic increase in intensity. These methods offer a non-invasive, holistic approach that might complement existing treatments and improve quality of life for patients.

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

This trial will compare two types of exercise therapy for Parkinson's disease: cardiovascular training and resistance training. Research has shown that aerobic exercise, such as cardiovascular training, can improve heart health and reduce the risk of heart disease in people with Parkinson's. Regular aerobic exercise may also slow the progression of Parkinson's and protect dopamine-producing brain cells, which are often lost in the disease. Meanwhile, resistance training has significantly increased muscle strength, by 15% to 83.2%, in people with Parkinson's. This type of exercise can also enhance coordination and balance, making everyday movements easier. Both exercise types improve movement-related symptoms in Parkinson's, making them promising therapy options. ^{2 3 6 7 8}

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 but are on stable medication. They should not be in other drug/exercise trials, have severe untreated sleep apnea, dementia or conditions that prevent exercise. A score >18 on PDSS-2 and <21 on MoCA excludes them.

Inclusion Criteria

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

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

You have been diagnosed with significant sleep problems, with a score higher than 18 on a sleep quality test called the PDSS-2.

Exclusion Criteria

You have a Beck Depression Inventory (BDI version 2) score higher than 4.

You have been regularly doing structured exercise at least twice a week for the past two months before joining the study.

I have a health condition that makes it hard for me to exercise.

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 or resistance training for 12 weeks, at least two times per week

12 weeks

24 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cardiovascular Training
• Resistance Training

Trial Overview

The study tests how cardiovascular (CT) and resistance training (RT) affect sleep quality in Parkinson's patients over 12 weeks of training at least twice a week. It also looks at whether better sleep improves brain function and life quality.

How Is the Trial Designed?

Group I: Resistance training 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 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.

Group II: Cardiovascular training 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 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.

Who Is Running the Clinical Trial?

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+

Jewish Rehabilitation Hospital

Collaborator

Trials

7

Recruited

810+

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]

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]

Exercise has numerous benefits for individuals with Parkinson's disease, helping to reduce disability and improve movement disorders.

This scoping review proposes specific exercise modalities, including Brazilian dance, deep-water exercises, and Nordic walking, along with walking tests to help therapists design effective exercise programs tailored for people with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Samba, deep water, and poles: a framework for exercise prescription in Parkinson's disease. Peyré-Tartaruga, LA., Martinez, FG., Zanardi, APJ., et al.[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]

Regular weight-training can lead to positive adaptations in cardiovascular health, including decreased heart rate during maximal work and improved myocardial structure, which may help reduce the risk of cardiovascular disease.

Resistance training can also enhance aerobic capacity and improve metabolic health markers like glucose tolerance and insulin sensitivity, although caution is advised for individuals with existing cardiovascular conditions due to potential blood pressure responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health- and performance-related potential of resistance training. Stone, MH., Fleck, SJ., Triplett, NT., 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 review of seven studies indicates that physical exercise significantly improves physical performance and activities of daily living in patients with Parkinson's disease, including enhancements in strength, balance, and mobility.

The findings suggest a need for standardized exercise programs tailored to Parkinson's disease and longer-term studies to evaluate the sustainability of these improvements beyond the intervention period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is physical exercise beneficial for persons with Parkinson's disease? Crizzle, AM., Newhouse, IJ.[2006]

A study involving 35 individuals with Parkinson's disease showed that both periodized resistance training with functional exercises and traditional resistance training significantly improved functional capacity, balance, and strength over 12 weeks.

The group that included functional training specifically showed improvements in freezing of gait, while traditional resistance training led to notable improvements in motor symptoms, suggesting tailored exercise programs can effectively address different challenges faced by individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periodized Resistance Training With and Without Functional Training Improves Functional Capacity, Balance, and Strength in Parkinson's Disease. Strand, KL., Cherup, NP., Totillo, MC., et al.[2023]

Regular exercise significantly benefits patients with heart disease by improving exercise tolerance, controlling risk factors, and potentially influencing the progression of coronary artery disease.

Patients should follow physician-guided exercise plans that include dynamic endurance activities and moderate-intensity circuit weight training, with a recommended duration of 2 to 3 hours per week, while high-risk patients should exercise at lower intensities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Heart patient and sports]. Niederhauser, HU.[2008]

Resistive exercise training is considered safe for selected individuals with cardiovascular impairment and can improve muscular strength, endurance, and overall cardiovascular health, making it beneficial for recovery after cardiac events.

Patients should undergo clinical screening and a symptom-limited exercise test before starting resistive training, and those at higher risk for cardiac events should avoid heavy lifting; however, circuit weight training and isometric exercises can enhance strength and self-efficacy with minimal risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistive exercise training in cardiac patients. Recommendations. Verrill, D., Shoup, E., McElveen, G., et al.[2018]

Isometric resistance training (IRT) has been shown to significantly lower blood pressure by an average of 7.4/3.3 mmHg, which is comparable to the effects of antihypertensive medications, and can reduce the risk of major cardiovascular events by 13% to 22%.

IRT is safe for a variety of patient populations and is particularly beneficial for individuals who cannot engage in aerobic exercise or have resistant hypertension, requiring only about 17 minutes of training per week.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evidence-based guide to the efficacy and safety of isometric resistance training in hypertension and clinical implications. Baffour-Awuah, B., Pearson, MJ., Dieberg, G., et al.[2023]

Blood flow-restricted (BFR) resistance training is safe for patients with coronary artery disease (CAD) and does not lead to any training-related adverse events, making it a viable exercise option.

After 8 weeks of BFR resistance training, patients showed significant improvements in muscle strength (+8.96 kg) and a reduction in systolic blood pressure (-6.77 mmHg), indicating its efficacy in enhancing physical function and cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Resistance Exercise Improves Muscle Strength and Hemodynamics, but Not Vascular Function in Coronary Artery Disease Patients: A Pilot Randomized Controlled Trial. Kambič, T., Novaković, M., Tomažin, K., et al.[2023]

Citations

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