Exercise for Parkinson's Disease

(EBEPD Trial)

Overseen By Jessamyn McKenzie

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pacific Parkinson's Research Centre

Disqualifiers: Diabetes, Hypertension, Neurological, Psychiatric, others

Compensation: Varies

Number of Visits: 3

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if exercise can improve how the brain uses energy in people with Parkinson's disease. Researchers will use brain scans to compare the effects of active exercise (physical activity or physical therapy) with passive exercise. Participants with mild to moderate Parkinson's who exercise less than 120 minutes a week may qualify. The study will compare brain activity in Parkinson's patients with that of healthy volunteers to identify any differences. As an unphased trial, this study provides participants the chance to contribute to groundbreaking research that could enhance understanding of Parkinson's disease and improve future treatments.

Will I have to stop taking my current medications?

The trial requires participants to be able to tolerate being off Parkinson's disease medication for up to 24 hours. Other medications or conditions may impact participation and will be discussed individually with the study team.

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

Past studies have shown that exercise is safe for people with Parkinson's disease (PD). Exercise plays a crucial role in managing PD and can improve movement and balance. Research indicates that most people can exercise without major issues, and it can also aid in mood and sleep problems.

One study found that exercise therapies can safely reduce PD symptoms. People with PD who remain active might also live longer. Therefore, both active and passive exercises used in the clinical trial are considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise approaches for Parkinson's Disease because they offer a unique way to manage symptoms compared to traditional medication and surgical options. Unlike typical treatments that focus on managing dopamine levels or deep brain stimulation, these exercise protocols aim to improve physical function and potentially slow disease progression through increased physical activity. The active exercise intervention starts immediately, allowing participants to potentially see benefits sooner, while the passive exercise arm helps maintain activity levels during a delayed start, offering a low-impact alternative. This trial could reveal important insights into how different types of exercise impact Parkinson's symptoms, paving the way for more holistic treatment strategies.

What evidence suggests that exercise might be an effective treatment for Parkinson's disease?

Research shows that exercise can help people with Parkinson's disease (PD) by improving movement and balance. This trial will compare two different exercise interventions. Participants in one arm will immediately start a six-month intervention of active exercise, which studies have found can lead to better overall health for those with PD, reducing symptoms and possibly lowering the risk of death. Participants in the other arm will undergo passive exercise for six months before starting active exercise. Exercise is linked to maintaining and improving movement, flexibility, and balance. It might also help with non-motor symptoms like mood and fatigue. Overall, staying active seems to be a promising way to manage Parkinson's disease. ^{1 3 4 5 6}

Who Is on the Research Team?

Vesna Sossi

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's Disease who can lay still for up to 90 minutes and are medically cleared to exercise. They shouldn't have severe claustrophobia, metal implants, significant cardiovascular or respiratory disease, other neurological or psychiatric disorders, recent surgeries or tattoos, substance use problems, be pregnant/breastfeeding, weigh over 158kg (347 lbs), or have a history of cancer within the last 5 years.

Inclusion Criteria

Currently exercise less than 120 minutes per week (PD non-exercisers)

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

I have Parkinson's disease diagnosed by specific criteria, family history allowed.

Exclusion Criteria

I cannot stay still for 90 minutes.

I am currently pregnant or breastfeeding.

I have chronic conditions like diabetes, kidney, heart issues, or neurological disorders.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline PET/MRI scans to assess initial brain energetics

1 week

1 visit (in-person)

Exercise Intervention

Non-exercisers undergo a supervised six-month exercise program with PET/MRI scans before and after

6 months

Multiple visits (in-person) for exercise sessions and scans

Delayed Intervention

Participants in the delayed intervention group undergo passive exercise for six months before starting active exercise

6 months

Multiple visits (in-person) for passive exercise sessions

Follow-up

Participants are monitored for changes in cognitive and motor function after the intervention

6 months

2 visits (in-person) for assessments

What Are the Treatments Tested in This Trial?

Interventions

• Active exercise
• Passive exercise

Trial Overview The study investigates if active and passive exercises affect brain energy usage in Parkinson's patients by comparing before-and-after brain scans using fMRI and PET. Healthy volunteers will also be scanned for comparison. Participants must currently exercise less than two hours per week.

How Is the Trial Designed?

Group I: Immediate intervention start: active exercise Active Control 1 Intervention

Immediately starts the six month intervention of active exercise following the baseline scan.

Group II: Delayed intervention start: passive exercise Placebo Group 2 Interventions

Starts the six month intervention of active exercise six months after the baseline scan. During the six month delay, participants in this arm undergo passive exercise.

Who Is Running the Clinical Trial?

Pacific Parkinson's Research Centre

Lead Sponsor

Trials

7

Recruited

170+

Natural Sciences and Engineering Research Council, Canada

Collaborator

Trials

63

Recruited

3,000+

Published Research Related to This Trial

In a 16-month study involving 121 individuals with Parkinson's disease, the flexibility/balance/function exercise (FBF) program showed significant improvements in overall physical function compared to a home-based control group at 4 months.

The supervised aerobic exercise (AE) program demonstrated better walking economy than the FBF program at multiple time points (4, 10, and 16 months), indicating its effectiveness in enhancing physical performance in individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for people in early- or mid-stage Parkinson disease: a 16-month randomized controlled trial. Schenkman, M., Hall, DA., Barón, AE., et al.[2022]

A 10-week exercise program significantly improved spinal flexibility and physical performance in 46 participants with early to midstage Parkinson's disease, compared to a control group that received no specific exercise.

The exercise intervention led to notable enhancements in functional axial rotation and functional reach, indicating that targeted physical activity can be beneficial for mobility in individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise to improve spinal flexibility and function for people with Parkinson's disease: a randomized, controlled trial. Schenkman, M., Cutson, TM., Kuchibhatla, M., et al.[2019]

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]

A review of 53 randomized controlled trials on exercise and motor training for Parkinson's disease showed that most interventions were effective and well-supervised, lasting an average of 8.3 weeks, with high participant retention rates (69% retained ≥85% of participants).

However, the lack of detailed reporting on adherence and adverse events in 72% of trials may hinder clinicians' ability to implement these programs effectively in practice, as they need to weigh the benefits against potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and motor training in people with Parkinson's disease: a systematic review of participant characteristics, intervention delivery, retention rates, adherence, and adverse events in clinical trials. Allen, NE., Sherrington, C., Suriyarachchi, GD., et al.[2021]

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 4-week intensive physical rehabilitation program significantly improved physical disability in patients with moderately advanced Parkinson's disease, as measured by the UPDRS assessment, particularly in activities of daily living and motor function.

However, these improvements were not maintained after the rehabilitation ended, as patients returned to their normal activity levels and UPDRS scores reverted to baseline within 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy and Parkinson's disease: a controlled clinical trial. Comella, CL., Stebbins, GT., Brown-Toms, N., et al.[2019]

Physical activity is shown to be a beneficial adjunct therapy for Parkinson's disease, significantly improving motor function, cognition, mood, and sleep habits in patients.

This review analyzed 31 studies, providing clinicians with a comprehensive resource on various exercises that can enhance the quality of life for individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Exercise in Parkinson's Disease. Emig, M., George, T., Zhang, JK., et al.[2021]

Physical activity and exercise may provide significant benefits for patients with Parkinson's disease (PD), potentially improving overall health and even modifying the disease, as suggested by animal studies.

Clinical trials are necessary to confirm these benefits and to ensure safety, particularly regarding the risks of falls and cardiovascular issues, while also focusing on creating tailored exercise programs that can help overcome barriers like depression and postural instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How might physical activity benefit patients with Parkinson disease? Speelman, AD., van de Warrenburg, BP., van Nimwegen, M., et al.[2022]

Exercise and rehabilitation programs become essential for Parkinson's disease patients when motor decline occurs despite DOPAtherapy, as they can help reduce daily life disability rather than directly improving core symptoms like bradykinesia or tremor.

Only a few well-designed studies exist on the effectiveness of rehabilitation in Parkinson's disease, but they suggest that early intervention with physiotherapy focusing on postural control and fall prevention can significantly benefit patients' independence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exercices program and rehabilitation of motor disorders in Parkinson's disease]. Pélissier, J., Pérennou, D.[2006]

Task-specific training with perturbations has been shown to effectively improve gait and balance in people with Parkinson's disease, potentially reducing the risk of falls, based on initial randomized controlled trials.

Combining task-specific training with cardiovascular exercise may enhance neuroplasticity, leading to better therapy outcomes, although the current quality of evidence for these approaches is still low and more rigorous studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New approaches in exercise therapy for Parkinson's disease]. Wanner, P., Klamroth, S., Steib, S.[2022]

Recent high-level studies indicate that targeted physical training, including strength and endurance exercises, can significantly improve mobility and balance in Parkinson's disease patients.

Speech therapy, particularly the Lee Silverman Voice Treatment, has been effective in addressing speech issues in Parkinson's patients, but further research is needed to confirm the benefits of other therapies like occupational and swallowing therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical, occupational, speech and swallowing therapies and physical exercise in Parkinson's disease. Ransmayr, G.[2022]

Exercise is a crucial part of managing Parkinson's disease (PD) and is shown to improve physical fitness, but there is a lack of standardized recommendations due to the variability in exercise interventions across 83 clinical trials.

The most common exercise prescription found was multimodal exercise for 60 minutes, twice a week over 12 weeks, highlighting the need for increased physical activity levels as an effective strategy for PD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity, Exercise, and Physiotherapy in Parkinson's Disease: Defining the Concepts. Bouça-Machado, R., Rosário, A., Caldeira, D., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7495242/

Exercise Therapies for Parkinson's Disease: A Systematic ... Exercise therapies were found to be relatively safe. Exercise therapies might promote improvements in the motor symptoms of Parkinson's disease.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6962680/

Physical Activity, Exercise, and Physiotherapy in ... Conclusion. The best available evidence recommends increasing physical activity levels in PD. Exercise and physiotherapy programs seem the most efficacious ...

3. neurology.org neurology.org/doi/10.1212/WNL.0000000000013218

Long-term Effect of Regular Physical Activity and Exercise ... In the long term, the maintenance of high regular physical activity levels and exercise habits was robustly associated with better clinical course of PD.

4. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2785851

Association of Physical Activity, Including Amount and ... Individuals with PD who were physically active both before and after the PD diagnosis showed the greatest reduction in mortality rate for all PA ...

5. parkinson.org parkinson.org/living-with-parkinsons/treatment/exercise

Exercise Research shows that exercise and physical activity can not only maintain and improve mobility, flexibility and balance but also ease non-motor PD symptoms.

6. jnnp.bmj.com jnnp.bmj.com/content/95/11/1077

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.