Speed Manipulated Adaptive Rehabilitation Therapy Bike for Parkinson's Disease

Study Overview
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Brief Summary
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Parkinson's disease (PD) is a progressive neurological disorder that results in slowness of movement, muscle stiffness, tremor, and postural instability. These symptoms significantly affect PD patients' quality of life, independence, and functional performance. There is currently no cure for PD, but symptoms can be treated with levodopa or deep brain stimulation surgery. Exercise-based rehabilitation has similar beneficial effects to surgical and pharmacological management without the potential negative side effects. Cycling-based interventions have been shown to increases motor function and mobility in individuals with PD. Specifically, benefits are greater when cycling cadence (revolutions per minute, RPM) is 30% greater than a self-selected pace. Although high cadence cycling improves motor function in individuals with PD, there is significant heterogeneity in individual responses. To maximize the treatment effects and minimize the heterogeneity of high-cadence cycling, it is important to determine patient-specific settings. Previous studies have shown that higher variability (entropy) of cadence leads to greater improvement in motor function. The entropy of cadence calculation will be utilized to understand how patient-specific settings can drive improvements. The purpose of this study is to determine patient-specific settings and measure the effects of high cadence stationary (i.e. dynamic) cycling on functional performance in individuals with PD. Volunteers with Parkinson's disease will complete 12 cycling sessions over a 1-month period and measures of motor function, quality of life, functional performance, mood and exercise readiness will be collected.

Detailed Description
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Potential participants will be prescreened with the ACSM pre-participation questionnaire over the phone or in person. Those who qualify will be asked to visit the research lab and sign the informed consent. Participants will be randomized into one of two groups: 1) patients-specific adaptive dynamic cycling or 2) non-adaptive dynamic cycling. Both groups will participate in a total of 12 sessions, each session consisting of 5 minutes of warm-up, 30 minutes of the main exercise, and 5 minutes of the cool-down period. 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. For the non-adaptive group, individuals will cycle on the dynamic bike with pre-determined settings that will stay constant throughout the exercise protocol.

Official Title
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Effects of Patient-Specific Adaptive Dynamic Cycling on Function Improvement in Individuals With Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: Dynamic high-cadence cycling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic Parkinson's disease 50-79 years of age no contraindications to exercise including cardiovascular disease or stroke Exclusion Criteria: one or more major signs/symptoms of cardiovascular or pulmonary disease

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled study with 2 arms
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adaptive dynamic cycling<br>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. | Behavioral: Dynamic high-cadence cycling<br>* Resistance settings will be changed based on entropy of cadence every 3 sessions. Cadence will be set at 80RPM for both groups<br>* Other names: S.M.A.R.T. cycling;|
| Active Comparator: Non-adaptive dynamic cycling<br>For the non-adaptive group, individuals will cycle on the dynamic bike with pre-determined settings that will stay constant throughout the exercise protocol. | Behavioral: Dynamic high-cadence cycling<br>* Resistance settings will be changed based on entropy of cadence every 3 sessions. Cadence will be set at 80RPM for both groups<br>* Other names: S.M.A.R.T. cycling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in motor symptoms | MDS-UPDRS Motor III (Movement Disorders Society- Unified Parkinson's Disease Rating Scale) Minimum Score-0 Maximum Score- 138 Lower score represents improvement | 4 weeks | 
| Change in motor kinematics | Kinesia One- Accelerometry | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | PDQ-39 (Parkinson' disease quality of life, 39 questions) Minimum Score- 0 Maximum Score- 156 | 4 weeks | 
| Change in mobility | Timed up and Go | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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movement disorders, exercise, adaptive therapy, cycling