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Completed

NCT Number: NCT04114318

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.

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Key information

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual-task cognitive-cycling training

Other

Cognitive and cycling training simultaneously for dual-task cognitive-cycling training; stationary bicycle exercise training for single-task cycling training

Other names: Single-task cycling training

Primary outcomes

  1. 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.

  2. Gait speed in cm/second

    Time frame: 5 minutes

    using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway

  3. Step length in cm

    Time frame: 5 minutes

    using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway

  4. Step width in cm

    Time frame: 5 minutes

    using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway

  5. Step time in second

    Time frame: 5 minutes

    using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway

  6. 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

  7. 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.

  8. 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 outcomes

  1. Cognitive performance

    Time frame: 10 minutes

    The cognitive performance was described as a composite score (%) = accuracy (%)/reaction time (ms) *100

  2. 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

  3. Adverse event

    Time frame: 5 minutes

    any complain from study subject

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 3, 2019
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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