Back to resultsEffects of Physical-Cognitive Training With Different Task Models in Parkinson's Disease With Mild Cognitive Impairment
Primary Purpose
Mild Cognitive Impairment, Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Integrated physical-cognitive training
Consecutive physical-cognitive training
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Dual-task walking training, Parkinson's disease, Mild cognitive impairment, Electroencephalography
Eligibility Criteria
Inclusion Criteria:
- a diagnosis of idiopathic Parkinson's disease
- have decreased cognitive functions but do not interfere with functional independence
- Montreal Cognitive Assessment (MoCA): 21-25
- able to walk independently without walking devices for at least 10 meters and with the ability to turn 180°
Exclusion Criteria:
- a diagnosis of dementia
- other diseases that may influence cognitive functions or walking performance
- a history of brain surgery
- modification of the medication during the exercise intervention
Sites / Locations
- National Taiwan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Integrated training model
Consecutive training model
Arm Description
Participants in this group will accept postural and cognitive training at the same time, e.g. naming animals while standing on the foam. Each training session will last for 70 minutes, twice a week, and 12 sessions in total.
Participants in this group will accept postural and cognitive training separately and for identical durations (both 30 minutes). Each training session will last for 70 minutes, twice a week, and 12 sessions in total.
Outcomes
Primary Outcome Measures
Change from baseline dual-task walking performance at 8 weeks
Fall frequency
Change from baseline Montreal Cognitive Assessment (MoCA) score at 8 weeks
MoCA: 0-30 points, higher scores mean a better outcome
Secondary Outcome Measures
Full Information
NCT ID
NCT05172661
First Posted
November 29, 2021
Last Updated
February 1, 2023
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05172661
Brief Title
Effects of Physical-Cognitive Training With Different Task Models in Parkinson's Disease With Mild Cognitive Impairment
Official Title
Effects of Physical-Cognitive Training With Different Task Models on Dual-Task Walking in Parkinson's Disease With Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 26, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The present study will characterize exercise model effects (integrated model vs. consecutive model) of physical-cognitive exercise on dual-task walking control in Parkinson's disease with mild cognitive impairment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Parkinson Disease
Keywords
Dual-task walking training, Parkinson's disease, Mild cognitive impairment, Electroencephalography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Integrated training model
Arm Type
Experimental
Arm Description
Participants in this group will accept postural and cognitive training at the same time, e.g. naming animals while standing on the foam.
Each training session will last for 70 minutes, twice a week, and 12 sessions in total.
Arm Title
Consecutive training model
Arm Type
Experimental
Arm Description
Participants in this group will accept postural and cognitive training separately and for identical durations (both 30 minutes).
Each training session will last for 70 minutes, twice a week, and 12 sessions in total.
Intervention Type
Behavioral
Intervention Name(s)
Integrated physical-cognitive training
Intervention Description
Perform a postural task and a cognitive task at the same time (dual-task model) 70 minutes/session*2 sessions/week*6 weeks
Intervention Type
Behavioral
Intervention Name(s)
Consecutive physical-cognitive training
Intervention Description
Perform a postural task and a cognitive task separately for identical durations 70 minutes/session*2 sessions/week*6 weeks
Primary Outcome Measure Information:
Title
Change from baseline dual-task walking performance at 8 weeks
Time Frame
8 weeks
Title
Fall frequency
Time Frame
20 weeks
Title
Change from baseline Montreal Cognitive Assessment (MoCA) score at 8 weeks
Description
MoCA: 0-30 points, higher scores mean a better outcome
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a diagnosis of idiopathic Parkinson's disease
have decreased cognitive functions but do not interfere with functional independence
Montreal Cognitive Assessment (MoCA): 21-25
able to walk independently without walking devices for at least 10 meters and with the ability to turn 180°
Exclusion Criteria:
a diagnosis of dementia
other diseases that may influence cognitive functions or walking performance
a history of brain surgery
modification of the medication during the exercise intervention
Facility Information:
Facility Name
National Taiwan University
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Physical-Cognitive Training With Different Task Models in Parkinson's Disease With Mild Cognitive Impairment
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