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
About this trial
This is an interventional treatment trial for Safety and Effectiveness
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
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
NCT ID
NCT04114318
First Posted
August 26, 2019
Last Updated
October 1, 2019
Sponsor
Chang Gung Memorial Hospital
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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