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?

The purpose of this study is to explore the relationships of exercise on inflammation in the body of older adults and people with Parkinson's disease (PD). This is important research for older adults but is especially important for people with PD because neuroinflammation is the main pathological mechanism that is responsible for neuron cell death in this neurodegenerative disease. As PD is a progressive disease, halting or slowing the degeneration is an important research target. Halting or slowing the disease progress is known as neuroprotection. Exercise is an attractive therapeutic treatment for people with PD as it has a lot of multi-systemic benefits, but also there is a lot of evidence to suggest that it helps improve symptoms and slow the progression of the disease. Exercise has been theorized to decrease inflammation and, therefore, has a lot of promise as a neuroprotective agent in slowing or halting the degeneration in PD. Unfortunately, there is not a lot of research that has looked into the effect of exercise on the biological processes of inflammation. Thus, the purpose of this study is to investigate the biological evidence that underlies the positive effect of exercise in people with PD.

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.

Is aerobic exercise safe for people with Parkinson's disease?

Aerobic exercise seems to be a safe activity for people with Parkinson's disease, although care should be taken to prevent falls in those who are at risk. ^{1 2 3 4 5}

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

Aerobic exercise is unique for Parkinson's disease as it focuses on improving physical fitness and motor symptoms through continuous movement of large muscles, unlike traditional drug treatments that primarily address symptoms. It may also slow disease progression and improve movement initiation, offering benefits similar to those seen in the general population. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Aerobic Exercise for Parkinson's Disease?

Research shows that aerobic exercise can improve movement initiation and aerobic capacity in people with Parkinson's Disease, which may help them move better and feel more energetic. It might also reduce the slowing of muscle activity that comes with the disease. ^{2 3 7 8 9}

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.

I am between 30 and 85 years old.

PwP: Neurologist-diagnosed PD

Exclusion Criteria

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

I am cleared to participate in moderate exercise.

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.

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

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]

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]

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]

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]

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]

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]

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]

Citations

1. Netherlands 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. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Aerobic exercise intervention improves aerobic capacity and movement initiation in Parkinson's disease patients. [2022]

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

Vigorous Aerobic Exercise in the Management of Parkinson Disease: A Systematic Review. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical Trial Highlights - Aerobic Exercise for Parkinson's Disease. [2023]

5. China 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. [2021]

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

Current Perspectives on Aerobic Exercise in People with Parkinson's Disease. [2022]

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

Cardiopulmonary Function and Aerobic Exercise in Parkinson's: A Systematic Review of the Literature. [2022]

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

Cardiovascular and metabolic responses to upper- and lower-extremity exercise in men with idiopathic Parkinson's disease. [2019]

9. Italy pubmed.ncbi.nlm.nih.gov

A randomised controlled cross-over trial of aerobic training versus Qigong in advanced Parkinson's disease. [2014]