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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive-Cycling | Experimental | Dual-task cognitive-cycling training; cognitive and cycling training simultaneously |
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| Cycling | Active Comparator | Single-task cycling training; stationary bicycle exercise training |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-task cognitive-cycling training | Other | Cognitive and cycling training simultaneously for dual-task cognitive-cycling training; stationary bicycle exercise training for single-task cycling training |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria: The patients were ineligible if they had
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| Name | Affiliation | Role |
|---|---|---|
| Chin-Song Lu, MD | Chang Gung Memorial Hospital | Principal Investigator |
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after publishing, we will share IPD
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2017 | Sep 15, 2019 | Prot_SAP_000.pdf |
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|
| 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 |
| 10 minutes |
| Adverse event | any complain from study subject | 5 minutes |