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

Trial Summary

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.

What data supports the effectiveness of the treatment involving exercise for Parkinson's disease?

Research shows that exercise therapy, including goal-based task-specific training, can improve motor symptoms and daily life activities in people with Parkinson's disease. Physical rehabilitation programs have been found to significantly improve physical disability and motor function, although these benefits may not last if regular exercise is not maintained. ^{1 2 3 4 5}

Is exercise safe for people with Parkinson's disease?

Exercise, including resistance and endurance training, is generally safe for people with Parkinson's disease and does not worsen symptoms. However, safety concerns like the risk of falls and cardiovascular issues should be considered, especially in more active patients. ^{1 6 7 8 9}

How does exercise treatment for Parkinson's disease differ from other treatments?

Exercise treatment for Parkinson's disease is unique because it focuses on improving motor symptoms through goal-based, task-specific training, which has shown to be more effective than nonspecific approaches. Unlike medication or surgery, exercise also enhances mood, cognition, and sleep, offering a holistic improvement in quality of life. ^{1 2 10 11 12}

What is the purpose of this trial?

There is increasing evidence that the usage and delivery of energy to the brain, known as brain energetics, is altered in people with Parkinson's disease (PD). This project will explore whether exercise has a positive impact on brain energetics using functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) brain scanning in PD subjects. PD subjects will be scanned before and after a supervised exercise program to investigate the effect of exercise on brain energetics. In a separate study, the investigators will also scan healthy volunteers to compare brain energetics in the healthy brain with the brain energetics data in PD subjects acquired in this study.

Research Team

Vesna Sossi

Principal Investigator

University of British Columbia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Physical Activity, Exercise, and Physiotherapy in Parkinson's Disease: Defining the Concepts. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

[New approaches in exercise therapy for Parkinson's disease]. [2022]

3. France pubmed.ncbi.nlm.nih.gov

[Exercices program and rehabilitation of motor disorders in Parkinson's disease]. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Physical therapy and Parkinson's disease: a controlled clinical trial. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Exercise to improve spinal flexibility and function for people with Parkinson's disease: a randomized, controlled trial. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Exercise for people in early- or mid-stage Parkinson disease: a 16-month randomized controlled trial. [2022]

7. United States 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. [2021]

8. Denmark pubmed.ncbi.nlm.nih.gov

Parkinson's disease and intensive exercise therapy - An updated systematic review and meta-analysis. [2022]

9. England pubmed.ncbi.nlm.nih.gov

How might physical activity benefit patients with Parkinson disease? [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The Role of Exercise in Parkinson's Disease. [2021]

11. Austria pubmed.ncbi.nlm.nih.gov

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

12. Korea (South) pubmed.ncbi.nlm.nih.gov

The Efficacy of Exercise Programs for Parkinson's Disease: Tai Chi versus Combined Exercise. [2021]