Safety and Effectiveness
Conditions
Brief summary
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
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).
Interventions
OTHERDual-task cognitive-cycling training
Cognitive and cycling training simultaneously for dual-task cognitive-cycling training; stationary bicycle exercise training for single-task cycling training
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unified Parkinson's disease rating scale | 30 minutes | 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. |
| Gait speed in cm/second | 5 minutes | using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway |
| Step length in cm | 5 minutes | using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway |
| Step width in cm | 5 minutes | using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway |
| Step time in second | 5 minutes | using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway |
| Double limb support time in second | 5 minutes | using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway |
| Modified Hoehn and Yahr staging | 5 minutes | 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. |
| Time up and go test in second | 2 minutes | The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive performance | 10 minutes | The cognitive performance was described as a composite score (%) = accuracy (%)/reaction time (ms) \*100 |
| Dual-task interference | 10 minutes | 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 |
| Adverse event | 5 minutes | any complain from study subject |
Outcome results
None listed