Cycling and Treadmill With Dual Task for Parkinson's Disease Improvement

Cycling Induced Motor Cortex Plasticity and Functional Improvement -the Dual Task Evaluation Model for Parkinson Disease

Motor impairment in lower extremities is common in individuals with Parkinson disease (PD). Development sensitive test for early motor deviations is important. Conventional walking test cannot induce the PD related motor impairments, such as freezing of gait. Therefore, finding a safe substitute test to induce PD related motor impairments is important.

Studies showed that working memory related dual task walking was a sensitive test for PD. However, the optimal cognitive test needs to be clarified. Studies also showed that the neuromuscular control mechanism of leg movements during cycling were similar to those during walking. Therefore, dual task cycling test is potential to be a safe and sensitive testing model.

Studies showed that exercise could improve cognitive function and induce brain plasticity. Dual task exercise training was shown to be more effective than single task exercise training for older people to prevent fall. Whether the added cognitive task could improve to detriment brain plasticity in PD should be investigated. Transcranial magnetic stimulation can evaluate the motor cortex plasticity on-invasively and can evaluate the exercise induced brain plasticity.

The purpose of this three-year project is to develop PD-sensitive. The purposes of the first year are to translate the dual task walking test to dual task cycling test, and to establish the reliability of the dual task cycling test.

The purposes of the second year are to compare the motor cortex plasticity induced by single task cycling versus dual task cycling and to compare the difference response between PD and healthy control people.

The purpose of the third year is to evaluate the effect of 8 week long term cycling training or treadmill training of individuals with PD on motor cortex plasticity, dual task performance, and ambulation ability.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease(PD)
• Intervention / Treatment: Other: Cognitive cycling training; Other: Cognitive treadmill training

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Chang Gung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Health subjects:

Exclusion Criteria:

• Musculoskeletal injuries on legs.
• Osteoporosis.

PD subjects:

Inclusion Criteria:

- Clinical diagnosis of Parkinson disease.

Exclusion Criteria:

• Musculoskeletal injuries on legs
• Osteoporosis.
• Any peripheral or central nervous system injury or disease patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Stage 3:PD Control group; Control group
No Intervention: Stage 1:Healthy people; To establish a baseline and ensure reliability, and to explore the relationship between dual-task gait performance and dual-task cycling
No Intervention: No Intervention: Stage 2:PD people; To explore the relationship between dual-task gait and dual-task cycling performances in individuals with Parkinson's Disease (PD)
Experimental: Stage 3:PD cycling training group; Cycling training conducted with cognitive tasks	Other: Cognitive cycling training; Cycling training conducted with cognitive tasks
Experimental: Stage 3: PD treadmill training group; Treadmill training conducted with cognitive tasks	Other: Cognitive treadmill training; Treadmill training conducted with cognitive tasks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking Speed	The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).	Baseline, 4 weeks and 8 weeks
Step Length	The linear distance between the two ankles, typically expressed in centimeters(cm).	Baseline, 4 weeks and 8 weeks
Step Time	The duration taken for one complete step, measuring from foot-off of one foot to the next foot-off of the same foot, usually expressed in seconds.	Baseline, 4 weeks and 8 weeks
Power Spectral Density (PSD)	Quantifies the power of EEG signals within specific frequency bands (e.g., delta, theta, alpha, beta, and gamma) over a period.	Baseline, 4 weeks and 8 weeks.
Task Accuracy	The percentage of correct responses or actions made by participants in response to walking or cycling tasks.	Baseline, 4 weeks and 8 weeks.
Reaction Time	The duration between the onset of task start time and the participant's response to it, typically expressed in second (s).	Baseline, 4 weeks and 8 weeks.
Balance Performance	Measured by the duration the stance can be maintained, typically expressed second.	Baseline, 4 weeks and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Double Support Time	The portion of the gait cycle where both feet are in contact with the ground, indicating the transition phase between steps, expressed as a percentage of the gait cycle or in seconds.	Baseline, 4 weeks and 8 weeks
Single Support Time	The duration within the gait cycle when only one foot is in contact with the ground, typically measured in seconds or as a percentage of the total gait cycle.	Baseline, 4 weeks and 8 weeks
Swing Time	The portion of the gait cycle where the foot is not in contact with the ground, moving forward to the next step. It is usually expressed as a percentage of the total gait cycle or in seconds.	Baseline, 4 weeks and 8 weeks
Stance Time	The portion of the gait cycle when the foot is in contact with the ground, supporting body weight. It's typically expressed as a percentage of the total gait cycle or in seconds	Baseline, 4 weeks and 8 weeks
Cadence	The number of steps an individual takes per minute, providing an overview of gait speed and rhythm, , expressed as steps per minute.	Baseline, 4 weeks and 8 weeks
Heart rate	The number of heartbeats per minute on resting, walking or cycling tasks.	Baseline

Collaborators and Investigators

• Sponsor: Chang Gung University

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2015
• Primary Completion (Actual): September 11, 2017
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Gait; Treadmill training; Dual-task walking; Cycling training; Dual-task cycling
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 103-7445B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No