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

Primary Purpose

Safety and Effectiveness

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dual-task cognitive-cycling training
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Safety and Effectiveness

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cognitive-Cycling

    Cycling

    Arm Description

    Dual-task cognitive-cycling training; cognitive and cycling training simultaneously

    Single-task cycling training; stationary bicycle exercise training

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    August 26, 2019
    Last Updated
    October 1, 2019
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04114318
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2016 (Actual)
    Primary Completion Date
    May 31, 2017 (Actual)
    Study Completion Date
    May 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Safety and Effectiveness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive-Cycling
    Arm Type
    Experimental
    Arm Description
    Dual-task cognitive-cycling training; cognitive and cycling training simultaneously
    Arm Title
    Cycling
    Arm Type
    Active Comparator
    Arm Description
    Single-task cycling training; stationary bicycle exercise training
    Intervention Type
    Other
    Intervention Name(s)
    Dual-task cognitive-cycling training
    Other Intervention Name(s)
    Single-task cycling training
    Intervention Description
    Cognitive and cycling training simultaneously for dual-task cognitive-cycling training; stationary bicycle exercise training for single-task cycling training
    Primary Outcome Measure Information:
    Title
    Unified Parkinson's disease rating scale
    Description
    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.
    Time Frame
    30 minutes
    Title
    Gait speed in cm/second
    Description
    using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
    Time Frame
    5 minutes
    Title
    Step length in cm
    Description
    using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
    Time Frame
    5 minutes
    Title
    Step width in cm
    Description
    using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
    Time Frame
    5 minutes
    Title
    Step time in second
    Description
    using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
    Time Frame
    5 minutes
    Title
    Double limb support time in second
    Description
    using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
    Time Frame
    5 minutes
    Title
    Modified Hoehn and Yahr staging
    Description
    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 Frame
    5 minutes
    Title
    Time up and go test in second
    Description
    The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility
    Time Frame
    2 minutes
    Secondary Outcome Measure Information:
    Title
    Cognitive performance
    Description
    The cognitive performance was described as a composite score (%) = accuracy (%)/reaction time (ms) *100
    Time Frame
    10 minutes
    Title
    Dual-task interference
    Description
    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
    Time Frame
    10 minutes
    Title
    Adverse event
    Description
    any complain from study subject
    Time Frame
    5 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chin-Song Lu, MD
    Organizational Affiliation
    Chang Gung Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    after publishing, we will share IPD

    Learn more about this trial

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

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