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

Kent State University

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Behavioral: Dynamic high-cadence cycling

Study type: Interventional

Funder types: Other

Identifiers

NCT05361200

SMARTPD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 50 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Adaptive dynamic cycling

Experimental group

Description:

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.

Treatment:

Behavioral: Dynamic high-cadence cycling

Non-adaptive dynamic cycling

Active Comparator group

Description:

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

Treatment:

Behavioral: Dynamic high-cadence cycling