Recruiting

Adaptive Rehabilitation

Sponsor:

Kent State University

Code:

NCT05361200

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Dynamic high-cadence cycling

Study Details

Brief summary:

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.

Conditions

Parkinson Disease

Study ID

NCT05361200

Start date

Apr 11, 2022

Status verified date

Feb, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Adaptive dynamic cycling

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.

active comparator: Non-adaptive dynamic cycling

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

Interventions

Dynamic high-cadence cycling

Resistance settings will be changed based on entropy of cadence every 3 sessions. Cadence will be set at 80RPM for both groups

Primary outcome measure

  • Change in motor symptoms [ Time Frame: 4 weeks ]
  • Change in motor kinematics [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Angela L Ridgel, PhD

330-672-7495aridgel@kent.edu

Locations

Kent State University

Recruiting

Kent, Ohio, United States, 44242

Contacts

More Information

Sponsor

Kent State University

Last update posted

Feb 16, 2024

Last verified

Feb, 2024

Keywords

  • movement disorders
  • exercise
  • adaptive therapy
  • cycling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kent State University on 2024-02-16.