High-Intensity Aerobic Exercise for Parkinson Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cleveland Clinic, Cleveland, OH
Parkinson Disease
High-Intensity Aerobic Exercise - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a long-term, high-intensity aerobic exercise intervention may have the potential to slow the progression of Parkinson's disease.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether High-Intensity Aerobic Exercise will improve 1 primary outcome, 1 secondary outcome, and 1 other outcome in patients with Parkinson Disease. Measurement will happen over the course of Baseline (on and off medications), 6 months (off medications), 12 months (off medication).

Month 12
MDS-UPDRS III Motor Score
Nine Hole Peg Test
Processing Speed Test

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Usual and Customary Care Group
1 of 2
High-Intensity Exercise Group
1 of 2
Active Control
Experimental Treatment

This trial requires 252 total participants across 2 different treatment groups

This trial involves 2 different treatments. High-Intensity Aerobic Exercise is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

High-Intensity Exercise Group
Other
Mild to moderate Parkinson's disease patients: The exercise group will be asked to cycle 3x/week for 12 months on a Peloton bicycle which will be delivered to their home.
Usual and Customary Care GroupMild to moderate Parkinson's disease patients, receiving no exercise intervention through the research. They will continue to receive usual and customary care for their Parkinson's disease during the 12 month period.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (on and off medications), 6 months (off medications), 12 months (off medication)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline (on and off medications), 6 months (off medications), 12 months (off medication) for reporting.

Who is running the study

Principal Investigator
J. A.
Jay Alberts, Principal Investigator
The Cleveland Clinic

Closest Location

Cleveland Clinic - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adult with a diagnosis of idiopathic PD by a physician or physician extender
Hoehn and Yahr stage I-III
Demonstrate the ability to safely mount and dismount the Peloton stationary cycle
In-home wireless network (WiFi; required for Peloton system exercise data transmission)

Patient Q&A Section

How many people get parkinson disease a year in the United States?

"About 1,300 new cases of Parkinson's disease are diagnosed each year in the United States. Most (89%) are male. Most (65%) have symptoms in their 40s and 60s. Only a small fraction of patients (5%) have no symptoms and is diagnosed before age 60. The majority have symptoms for up to 20 years." - Anonymous Online Contributor

Unverified Answer

What are the signs of parkinson disease?

"Many patients will be newly diagnosed with PD as they are experiencing motor symptoms. Physicians should be familiar with the symptoms of PD and be able to identify key signs that should prompt further investigation. The clinical manifestations of PD are typically progressive before death. Thus, patients, their families, and health professionals need to know how PD changes over time and how to recognize its early onset. Further clinical examination and objective measurement of Parkinson's signs are recommended for this purpose to ensure timely diagnosis and to optimize the treatment of PD." - Anonymous Online Contributor

Unverified Answer

What is parkinson disease?

"parkinson disease is a chronic and slowly progressive neurodegenerative disorder that causes abnormal movement of muscles, including stiffness, slowness, and tremor. The word "parkinson" is from the Greek word for shaking, Parkinson's disease, is the second most common neurodegenerative disorder after Alzheimer's disease.\n" - Anonymous Online Contributor

Unverified Answer

Can parkinson disease be cured?

"The treatment of PD with levodopa can reduce the symptoms of PD for up to 20 years. The benefits of levodopa outweigh the risks associated with it. Thus levodopa can be used to achieve a successful outcome in PD. The risk of being cured by levodopa needs to be weighed against the risk of levodopa toxicity. The use of deep brain stimulation has not been proven to be curative in refractory PD and may require surgery. Therefore, only certain PD patients should start levodopa treatment to try to achieve a cure." - Anonymous Online Contributor

Unverified Answer

What are common treatments for parkinson disease?

"More than 60% of adults with PD utilize multiple drugs for treatment. Physicians should monitor patients for compliance with their treatment regimen and use of complementary and alternative medicines." - Anonymous Online Contributor

Unverified Answer

What causes parkinson disease?

"Parkinson disease has a complex aetiology. The strongest risk factor for Parkinson disease is old age; however, other risk factors include environmental and genetic factors. People with no family history of parkinsonism have an increased risk of developing Parkinson disease compared to genetic mutations. The causes include environmental factors, including the use of pesticides or the industrial use of cobalt.\nTreatment may include dopamine agonists and anticholinergic drugs. Surgery or other interventions may be used to improve symptoms or control complications.\nThere are a number of risk factors that increase the risk of developing Parkinson's disease. Many people, however, have no known risk factors as the disease occurs randomly and is thought to develop at random." - Anonymous Online Contributor

Unverified Answer

Has high-intensity aerobic exercise proven to be more effective than a placebo?

"The inclusion criteria (no previous exercise or medicine therapy and at least six months of the study, but not less than three months of the study), the choice of treatment, and the follow-up period was not well-defined. The subjects were not blinded by the researchers to which group they were assigned and the subjects did not receive the best available treatment." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets parkinson disease?

"Age of onset is generally earlier than age of diagnosis in patients with PD. More research is needed to confirm the gender difference and to identify the age of onset of the disease in patients diagnosed with PD in different geographical areas and in patients with different ages and ethnic backgrounds." - Anonymous Online Contributor

Unverified Answer

Is high-intensity aerobic exercise safe for people?

"High-intensity aerobic exercise can be a safe and useful strategy to achieve a reduction in the risk of falling in older people with Parkinson's disease." - Anonymous Online Contributor

Unverified Answer

What is high-intensity aerobic exercise?

"Moderate intensity aerobic exercise induced improvements in quality of life and a more rapid decrease in depressive symptoms in patients presenting with Parkinson's disease. Aerobic exercise may have a preventive role in PD, by reducing the clinical severity of the disease and improving the quality of life." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating parkinson disease?

"Until now, there has not been any drug that has a positive effect in the treatment of PD. [The drugs currently available for treating PD are the levodopa (often combined with dopamine agonists) and dopamine antagonist, such as bromocriptine. These drugs can decrease the motor complications of PD and may help to regulate the disease severity in the long term.] [No new medicines have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of PD. If you are looking to join a PD clinical trial, [with the Power tool (http://www.withpower." - Anonymous Online Contributor

Unverified Answer

How does high-intensity aerobic exercise work?

"Aerobic exercise at high levels is an important component to the benefits of exercise and is a well-established treatment for Parkinson's disease. Based on the findings of this meta analysis there remain unanswered questions, such as how do we determine intensity for the benefits and when do we need to increase exercise to improve symptoms. Future studies should be conducted to determine what level of intensity leads to improvements in motor function, physical functioning and quality of life." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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