Aerobic Exercise for Parkinson's Disease

(PDex Trial)

Recruiting at 1 trial location

Overseen By Merrill Landers, PT, DPT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nevada, Las Vegas

Disqualifiers: Heart arrhythmias, Uncontrolled blood pressure, Dementia, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how aerobic exercise might reduce inflammation in people with Parkinson's disease (PD) and older adults. The goal is to determine if exercise can slow PD progression by protecting nerve cells. Participants in the PD group have a neurologist-diagnosed Parkinson's and can perform moderate aerobic exercise for 30 minutes with short breaks. The trial will compare results between those with PD and a control group of older adults without major medical issues. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance the quality of life for those with Parkinson's disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that aerobic exercise is safe for older adults and people with Parkinson's disease?

Research has shown that aerobic exercise is safe and beneficial for people with Parkinson's disease (PD). It can enhance movement, balance, and even alleviate non-motor symptoms of PD. Studies suggest that exercise might slow the disease by protecting dopamine-producing brain cells, which are vital for movement.

One study demonstrated that six months of high-intensity aerobic exercise helped protect these crucial brain cells. Another study found that regular aerobic exercise improved disease severity, balance, and movement in patients with mild to moderate PD.

Overall, exercise not only supports general health but may also help slow the progression of Parkinson's. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about aerobic exercise as a treatment for Parkinson's Disease because it offers a non-drug approach to managing symptoms. Unlike traditional treatments like medication or surgery, aerobic exercise can improve motor function and overall quality of life without the side effects associated with drugs. Additionally, exercise is accessible and can be tailored to individual abilities, making it a versatile option for many patients. This approach not only targets the physical symptoms of Parkinson's but also promotes overall health and well-being.

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

Research has shown that aerobic exercise can greatly benefit people with Parkinson's disease (PD). Studies have found improvements in balance, walking speed, and movement skills for those with PD. Evidence also suggests that aerobic exercise can lower the risk of developing Parkinsonism, particularly in men. Although regular exercise has not been proven to significantly slow the overall progression of PD in all studies, it offers many health benefits, such as reducing the risk of heart disease and lowering the chance of early death. Exercise is believed to reduce inflammation, potentially protecting nerve cells from damage in PD. Overall, aerobic exercise appears promising as a supportive method to improve symptoms in PD.

In this trial, participants diagnosed with Parkinson's disease will engage in aerobic exercise, and researchers will compare their outcomes to a control group of age- and sex-matched older adults. ^{1 2 3 6 7}

Who Is on the Research Team?

Merrill Landers, DPT, PhD

Principal Investigator

University of Nevada, Las Vegas

Are You a Good Fit for This Trial?

This trial is for people aged 30-85 with Parkinson's disease who can do 30 minutes of moderate exercise with short breaks, and healthy adults in the same age range. It excludes those with conditions like heart issues or uncontrolled blood pressure that prevent safe exercise, and those with dementia as indicated by a low score on a cognitive assessment.

Inclusion Criteria

I am between 30 and 85 years old.

PwP: Neurologist-diagnosed PD

PwP: Able to participate in 30 minutes of continuous moderate aerobic exercise with 2-3 short breaks per self-report

Exclusion Criteria

I don't have health issues like heart problems or uncontrolled blood pressure that stop me from exercising.

Those with dementia will be excluded because there are self-report questionnaires in this study. This will be identified using the Montreal Cognitive Assessment and a score at or below a 21. Participants with mild cognitive impairment and no impairment will be included.

I am cleared to participate in moderate exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurement of blood serum levels of various biomarkers

1 day

1 visit (in-person)

Exercise Intervention

Participants undergo 30 minutes of aerobic exercise at different intensities to assess changes in biomarkers

2 weeks

2 visits (in-person), 1 week apart

Follow-up

Participants are monitored for changes in biomarkers and overall health

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic exercise

Trial Overview

The study investigates how aerobic exercise might protect brain cells from dying in Parkinson's disease by reducing inflammation. Participants will engage in regular moderate aerobic exercises to see if this slows down the progression of their condition.

How Is the Trial Designed?

Group I: Control Active Control 1 Intervention

Older, adults who are age- and sex-matched to the PD participants.

Group II: Parkinson Disease Active Control 1 Intervention

Participants diagnosed with Parkinson disease (PD) will the main arm of the study and will be compared to the control group.

Aerobic exercise is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function
• Reduction of depression

Approved in European Union as Aerobic Exercise for:

• Cardiovascular rehabilitation
• Improvement of physical function
• Enhancement of cognitive function

Approved in Canada as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function

Who Is Running the Clinical Trial?

University of Nevada, Las Vegas

Lead Sponsor

Trials

81

Recruited

14,700+

Published Research Related to This Trial

Individuals with mild to moderate Parkinson's disease (PD) can achieve peak exercise capacity similar to those without PD, but they exhibit lower peak power during both upper- and lower-extremity exercises.

Submaximal heart rate and oxygen consumption were higher in individuals with PD compared to controls, indicating a different physiological response to exercise despite similar maximal performance levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular and metabolic responses to upper- and lower-extremity exercise in men with idiopathic Parkinson's disease. Protas, EJ., Stanley, RK., Jankovic, J., et al.[2019]

A systematic review of seven studies, including five randomized controlled trials, found that vigorous-intensity aerobic exercise did not lead to significant improvements in motor function or disease severity in individuals with Parkinson disease compared to moderate or low-intensity exercise.

Only one study indicated that vigorous-intensity exercise resulted in higher aerobic fitness, but overall, the evidence is insufficient to recommend vigorous exercise as a standard treatment for Parkinson disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vigorous Aerobic Exercise in the Management of Parkinson Disease: A Systematic Review. Rodríguez, MÁ., Albillos-Almaraz, L., López-Aguado, I., et al.[2021]

A 16-week aerobic exercise program for 8 Parkinson's Disease patients led to a significant 26% improvement in aerobic capacity, indicating that exercise can benefit PD patients similarly to healthy individuals.

The intervention also resulted in faster movement initiation times, suggesting that aerobic exercise may help counteract the slowing of muscle activation associated with Parkinson's Disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic exercise intervention improves aerobic capacity and movement initiation in Parkinson's disease patients. Bergen, JL., Toole, T., Elliott, RG., et al.[2022]

Moderate aerobic exercise significantly improves balance and gait in patients with Parkinson's disease, based on a systematic review of nine randomized controlled trials involving 444 patients.

While moderate aerobic exercise does not show a significant effect on overall motor symptoms, different types of exercise, particularly treadmill workouts, can enhance the quality of life for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of moderate aerobic exercise for patients with Parkinson's disease: a systematic review and meta-analysis of randomized controlled trials. Li, Y., Song, H., Shen, L., et al.[2021]

Aerobic exercise is a safe and effective complementary treatment for people with Parkinson's disease, showing significant improvements in physical fitness (VO2max) and motor symptoms, particularly when performed at higher intensities.

While aerobic exercise offers general health benefits and may reduce cardiovascular risks, there is currently insufficient evidence regarding its impact on health-related quality of life and non-motor symptoms in Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Perspectives on Aerobic Exercise in People with Parkinson's Disease. Schootemeijer, S., van der Kolk, NM., Bloem, BR., et al.[2022]

A systematic review of nine studies found that aerobic exercise positively impacts cardiac function in individuals with early-stage Parkinson's disease, suggesting potential benefits for heart health.

However, there is a significant gap in research regarding the effects of aerobic exercise on pulmonary function in Parkinson's patients, indicating a need for further studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiopulmonary Function and Aerobic Exercise in Parkinson's: A Systematic Review of the Literature. Aburub, A., Ledger, SJ., Sim, J., et al.[2022]

Aerobic training significantly improved physical performance in Parkinson's disease patients, as evidenced by increased distance in the Six-Minute Walking Test and reduced breathlessness, while Qigong did not show similar benefits.

Despite the improvements in exercise capacity, aerobic training did not lead to significant changes in overall self-sufficiency or quality of life measures, indicating that while it helps with physical ability, it may not address broader aspects of living with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled cross-over trial of aerobic training versus Qigong in advanced Parkinson's disease. Burini, D., Farabollini, B., Iacucci, S., et al.[2014]

Aerobic exercise may positively affect motor symptoms in Parkinson's disease and could potentially slow its progression, as suggested by ongoing randomized clinical trials (RCTs).

The review identified six RCTs with participant numbers ranging from 28 to 370 and follow-up periods between 8 weeks and 18 months, highlighting the need for more studies that explore both clinical outcomes and neuroplasticity markers to determine the best exercise parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Trial Highlights - Aerobic Exercise for Parkinson's Disease. Schootemeijer, S., Darweesh, SKL., de Vries, NM.[2023]

Aerobic exercise (AE) can improve gait, specifically walking speed and stride length, as well as mobility and lower limb muscle strength in individuals with mild to moderate Parkinson's disease, based on a review of 10 studies involving 411 participants.

However, the evidence for improvements in cardiorespiratory function, postural balance, and overall quality of life was found to be low or very low, indicating that while AE has some benefits, it may not significantly enhance quality of life for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of aerobic exercise on functional capacity and quality of life in individuals with Parkinson's disease: A systematic review of randomized controlled trials. de Oliveira, MPB., Lobato, DFM., Smaili, SM., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

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

A systematic review and meta-analysis on effects of aerobic ...

Aerobic exercise had beneficial effects in improving balance, gait (velocity and stride/step length), and motor function in PD patients.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7851311/

Current Perspectives on Aerobic Exercise in People with ...

Aerobic exercise has generic health benefits for people with PD, including a reduced incidence of cardiovascular disease, a lower mortality, and an improved ...

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frontiersin.org

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

Effectiveness of aerobic and resistance training on the ...

Our results show that different aerobic and resistance training showed effects in PD patients, reflecting the complementary efficacy of aerobic ...

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neurology.org

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Long-term Effect of Regular Physical Activity and Exercise ...

Regular physical activity and moderate to vigorous exercise levels at baseline did not significantly affect the subsequent clinical progression of PD. However, ...

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jnnp.bmj.com

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

Exercise as medicine in Parkinson's disease

20 Here, the active group (vs sedentary) showed a lower risk of Parkinsonism (HR: 0.18; 95% CI: 0.07 to 0.51), but this effect was restricted to men (HR: 0.34; ...

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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.

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medicine.yale.edu

medicine.yale.edu/news-article/high-intensity-exercise-can-reverse-neurodegeneration-in-parkinsons-disease/

High-intensity Exercise May Reverse Neurodegeneration in ...

Six months of high-intensity aerobic exercise preserves the dopamine-producing neurons in the brain, a small pilot study finds.