90 Participants Needed

Aerobic Exercise for Parkinson's Disease

(PDex Trial)

Recruiting at 1 trial location
ML
ML
Overseen ByMerrill Landers, PT, DPT, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Nevada, Las Vegas
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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.

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.12345

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.25678

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.24569

Research Team

ML

Merrill Landers, DPT, PhD

Principal Investigator

University of Nevada, Las Vegas

Eligibility Criteria

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
See 3 more

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Older, adults who are age- and sex-matched to the PD participants.
Group II: Parkinson DiseaseActive Control1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Nevada, Las Vegas

Lead Sponsor

Trials
81
Recruited
14,700+

Findings from Research

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

References

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]
Aerobic exercise intervention improves aerobic capacity and movement initiation in Parkinson's disease patients. [2022]
Vigorous Aerobic Exercise in the Management of Parkinson Disease: A Systematic Review. [2021]
Clinical Trial Highlights - Aerobic Exercise for Parkinson's Disease. [2023]
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]
Current Perspectives on Aerobic Exercise in People with Parkinson's Disease. [2022]
Cardiopulmonary Function and Aerobic Exercise in Parkinson's: A Systematic Review of the Literature. [2022]
Cardiovascular and metabolic responses to upper- and lower-extremity exercise in men with idiopathic Parkinson's disease. [2019]
A randomised controlled cross-over trial of aerobic training versus Qigong in advanced Parkinson's disease. [2014]
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