Clinical trial NCT04114318: The Role of Cycling-cognitive Dual-task Training in Early Parkinson's Disease
Official title: The Role of Cycling-cognitive Dual-task Training in Early Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety and Effectiveness
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 26
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Unified Parkinson's disease rating scale
timeFrame: 30 minutes
measure: Gait speed in cm/second
timeFrame: 5 minutes
measure: Step length in cm
timeFrame: 5 minutes
measure: Step width in cm
timeFrame: 5 minutes
measure: Step time in second
timeFrame: 5 minutes
measure: Double limb support time in second
timeFrame: 5 minutes
measure: Modified Hoehn and Yahr staging
timeFrame: 5 minutes
measure: Time up and go test in second
timeFrame: 2 minutes
Secondary outcomes:
measure: Cognitive performance
timeFrame: 10 minutes
measure: Dual-task interference
timeFrame: 10 minutes
measure: Adverse event
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chin-Song Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: