The Role of Cycling-cognitive Dual-task Training in Early Parkinson's Disease

Study Overview
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Brief Summary
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The purpose of the study will investigate the safety and effectiveness with eight-week cycling-cognitive dual-task training for early Parkinson's disease.

Detailed Description
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Background: Parkinson's disease is a neurodegenerative disorder of the basal ganglia in which the production of dopamine is reduced, leading to the motor and non-motor impairment and the loss of automaticity. Recently, the results across studies have indicated that motor-cognitive dual-task deficits in individuals with neurologic disorders appear to be amenable to training. Improvement of dual-task ability in individuals with neurologic disorders holds potential for improving gait, balance, and cognition. The most recent European guideline provides a more graded view, stating that in Hoehn and Yahr stages 2 and 3 dual-task training may be safe and effective. An overview of current ongoing randomized controlled trials focusing on dual-task rehabilitation, gait training or treadmill training was the major motor-task. However, cycling augmented by cognitive training has not been evaluated. In addition, antioxidant capacity is unclear for Parkinson's disease patients with long-term, regular cycling training. Study purpose: The purpose of the study will investigate the safety and effectiveness with eight-week cycling-cognitive dual-task training for early Parkinson's disease. The antioxidant capacity will be assessed as well. Methods: Parkinson's disease patients will be assigned to cycling training, cycling-cognitive dual task training, and following 8 weeks. All of the subjects will complete 3 assessments at pre-training, post-4 weeks, and post-8 weeks. The outcome measures are clinical severity and disability, performance of gait-cognitive and cycling-cognitive, cognitive-task performance, peripheral-blood oxidative stress, adverse events, etc. Significance: In this study, evidence-based practice as the foundation, and perspective to design a safe and effective cycling-cognitive dual-task training for early Parkinson's disease. It can be verified in the clinical application of these experiments feasibility (practice-based evidence).

Official Title
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The Role of Cycling-cognitive Dual-task Training in Early Parkinson's Disease

Conditions
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Safety and Effectiveness

Intervention / Treatment
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* Other: Dual-task cognitive-cycling training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with Idiopathic Parkinson's disease (IPD) an age between 45 to 70 years asymmetrical onset of at least 2 of 3 cardinal sign Modified Hoehn and Yahr staging from 1 to 2.5 during off state Montreal cognitive assessment score of 26 or greater Exclusion Criteria: The patients were ineligible if they had a neurological history other than Parkinson's disease ever undergone neurosurgery for Parkinson's disease had moderate to severe dyskinesia been unstable with medical or psychiatric co-morbidities, orthopedic conditions restricting exercise done more than 20 min of aerobic exercise over 3 sessions per week on their own

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-Cycling<br>Dual-task cognitive-cycling training; cognitive and cycling training simultaneously | Other: Dual-task cognitive-cycling training<br>* Cognitive and cycling training simultaneously for dual-task cognitive-cycling training; stationary bicycle exercise training for single-task cycling training<br>* Other names: Single-task cycling training;|
| Active Comparator: Cycling<br>Single-task cycling training; stationary bicycle exercise training | Other: Dual-task cognitive-cycling training<br>* Cognitive and cycling training simultaneously for dual-task cognitive-cycling training; stationary bicycle exercise training for single-task cycling training<br>* Other names: Single-task cycling training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's disease rating scale | There are 4 parts subscores: part 1 (0-16), part 2 (0-52), part 3 (0-96), part 4 (0-23). Total scale range 0-187 (summed part 1, 2, 3, 4), higher values represent a worse outcome. | 30 minutes | 
| Gait speed in cm/second | using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway | 5 minutes | 
| Step length in cm | using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway | 5 minutes | 
| Step width in cm | using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway | 5 minutes | 
| Step time in second | using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway | 5 minutes | 
| Double limb support time in second | using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway | 5 minutes | 
| Modified Hoehn and Yahr staging | scale range 0-5. The scale was originally described in 1967 and included stages 1 through 5. It has since been modified with the addition of stages 1.5 and 2.5 to account for the intermediate course of Parkinson disease. | 5 minutes | 
| Time up and go test in second | The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility | 2 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive performance | The cognitive performance was described as a composite score (%) = accuracy (%)/reaction time (ms) *100 | 10 minutes | 
| Dual-task interference | The effect of the dual-task was calculated as the difference between single-task and dual-task performance expressed as a percentage of single-task performance | 10 minutes | 
| Adverse event | any complain from study subject | 5 minutes |