The Role of Cycling-cognitive Dual-task Training in Early Parkinson's Disease
- Conditions
- Safety and Effectiveness
- Interventions
- Other: Dual-task cognitive-cycling training
- Registration Number
- NCT04114318
- Lead Sponsor
- Chang Gung Memorial Hospital
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cycling Dual-task cognitive-cycling training Single-task cycling training; stationary bicycle exercise training Cognitive-Cycling Dual-task cognitive-cycling training Dual-task cognitive-cycling training; cognitive and cycling training simultaneously
- Primary Outcome Measures
Name Time Method Double limb support time in 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
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.
Gait speed in cm/second 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
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
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.
Step width in cm 5 minutes using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
- Secondary Outcome Measures
Name Time Method 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