What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease include levodopa, dopamine agonists, and exercise-based rehabilitation like high-cadence cycling. Levodopa can cause dyskinesia, nausea, dizziness, and hallucinations. Dopamine agonists, such as pramipexole and ropinirole, may lead to somnolence, edema, constipation, and hallucinations. Exercise-based rehabilitation typically has fewer side effects, with muscle soreness or fatigue being the most common. These treatments focus on enhancing motor function and mobility in PD patients.

What prior FDA approvals exist?

Levodopa, often combined with carbidopa, is a cornerstone treatment for managing motor symptoms in Parkinson's Disease. Other FDA-approved medications include dopamine agonists like pramipexole and ropinirole, MAO-B inhibitors such as selegiline and rasagiline, and COMT inhibitors like entacapone. Deep brain stimulation (DBS) is a surgical option for advanced cases. Exercise-based interventions, while not FDA-approved as a treatment per se, have shown significant benefits in clinical studies, particularly high-cadence cycling, which improves motor function and mobility.

What other types of research exist?

Promising, novel alternatives to high-cadence cycling for Parkinson's Disease patients include: 1) Rhythmic, music-based movement training, which leverages rhythmic cues to improve mobility and postural stability. 2) Imagining and mimicking bicycling, which has shown to improve freezing of gait (FOG) by providing nonexternal cues to maintain rhythmic gait. 3) Adaptive devices such as noninvasive neuromodulation and biomechanical loading, which can reduce tremor severity and improve motor function. These alternatives offer diverse approaches to enhance motor function and mobility in PD patients.

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Behavioral Intervention

Speed Manipulated Adaptive Rehabilitation Therapy Bike for Parkinson's Disease (SMART Trial)

N/A

Recruiting

Research Sponsored by Kent State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Idiopathic Parkinson's disease

50-79 years of age

Must not have

Presence of one or more major signs/symptoms of cardiovascular or pulmonary disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial uses high-speed cycling on a stationary bike to help people with Parkinson's disease improve their movement. Participants will have personalized bike settings to maximize benefits based on their performance. High-speed cycling on a stationary bike has been shown to improve motor functions in patients with Parkinson's disease, similar to high-intensity rehabilitation programs.

Who is the study for?

This trial is for individuals aged 50-79 with idiopathic Parkinson's disease who can safely exercise without the risk of cardiovascular or pulmonary complications. It aims to help those looking to improve their motor function and quality of life through a specialized cycling program.

What is being tested?

The study tests dynamic high-cadence cycling, which means pedaling at a speed faster than one's natural pace, to see if it improves movement and functional performance in Parkinson's patients. Participants will cycle in 12 sessions over a month while being monitored for improvements.

What are the potential side effects?

Since this intervention involves physical exercise, potential side effects may include muscle soreness, fatigue, and an increased risk of falls or injuries related to balance issues that are common in Parkinson’s disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Parkinson's disease.

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I am between 50 and 79 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have major heart or lung disease symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in motor kinematics

Change in motor symptoms

Secondary study objectives

Change in mobility

Change in quality of life

Other study objectives

Change in affect

Change in mood

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Adaptive dynamic cyclingExperimental Treatment1 Intervention

For the patient-specific adaptive dynamic cycling group, the optimization process will be done after the 3rd, 6th, and 9th sessions. The optimization procedure is based on sample entropy of cadence calculation from the previous session's cycling performance. After optimization, participants will receive specific settings for the next session.

Group II: Non-adaptive dynamic cyclingActive Control1 Intervention

For the non-adaptive group, individuals will cycle on the dynamic bike with pre-determined settings that will stay constant throughout the exercise protocol.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Parkinson's Disease (PD) include pharmacological options like levodopa, dopamine agonists, and MAO-B inhibitors, as well as non-pharmacological interventions such as high-cadence cycling. Levodopa replenishes brain dopamine levels, dopamine agonists stimulate dopamine receptors, and MAO-B inhibitors prevent dopamine breakdown. High-cadence cycling improves motor function and mobility by optimizing cadence variability, enhancing neural activation and motor control. These treatments are essential for managing motor symptoms, improving quality of life, and maintaining functional independence in PD patients.

Can music-based movement therapy improve motor dysfunction in patients with Parkinson's disease? Systematic review and meta-analysis.Context-Dependent Neural Activation: Internally and Externally Guided Rhythmic Lower Limb Movement in Individuals With and Without Neurodegenerative Disease.