The Role of Cycling-cognitive Dual-task Training in Early Parkinson’s Disease

Overview

The purpose of the study will investigate the safety and effectiveness with eight-week cycling-cognitive dual-task training for early Parkinson's disease.

Full Title of Study: “The Role of Cycling-cognitive Dual-task Training in Early Parkinson’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 31, 2017

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

  • Other: Dual-task cognitive-cycling training
    • Cognitive and cycling training simultaneously for dual-task cognitive-cycling training; stationary bicycle exercise training for single-task cycling training

Arms, Groups and Cohorts

  • Experimental: Cognitive-Cycling
    • Dual-task cognitive-cycling training; cognitive and cycling training simultaneously
  • Active Comparator: Cycling
    • Single-task cycling training; stationary bicycle exercise training

Clinical Trial Outcome Measures

Primary Measures

  • Unified Parkinson’s disease rating scale
    • Time Frame: 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
    • Time Frame: 5 minutes
    • using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
  • Step length in cm
    • Time Frame: 5 minutes
    • using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
  • Step width in cm
    • Time Frame: 5 minutes
    • using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
  • Step time in second
    • Time Frame: 5 minutes
    • using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
  • Double limb support time in second
    • Time Frame: 5 minutes
    • using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
  • Modified Hoehn and Yahr staging
    • Time Frame: 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
    • Time Frame: 2 minutes
    • The Timed Up and Go test (TUG) is a simple test used to assess a person’s mobility

Secondary Measures

  • Cognitive performance
    • Time Frame: 10 minutes
    • The cognitive performance was described as a composite score (%) = accuracy (%)/reaction time (ms) *100
  • Dual-task interference
    • Time Frame: 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
    • Time Frame: 5 minutes
    • any complain from study subject

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chang Gung Memorial Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chin-Song Lu, MD, Principal Investigator, Chang Gung Memorial Hospital

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