Safety and Effectiveness Clinical Trial
Official title:
The Role of Cycling-cognitive Dual-task Training in Early Parkinson's Disease
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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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03800706 -
A Phase II Study to Evaluate the Safety and Efficacy of TQB2450 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma
|
Phase 2 |