Dual-task Cycling System on Cognitive Function for the Elderly
Primary Purpose
Cognitive Impairment
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Dual-task Group
Cycling Group
Cognitive Group
Sponsored by
About this trial
This is an interventional treatment trial for Cognitive Impairment
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of MCI or cutoff at 2 < n < 16 th percentile MoCA score according to the level of education and age
- Sufficient cognitive ability to follow simple instructions
- Able to understand content and purpose of the study
- Conscious and in stable physical condition
Exclusion Criteria:
- Any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopaedic or chronic pain condition; or
- Severe hip, knee or ankle contracture that would preclude the passive range of motion of the leg
- Uncontrolled Cardiac issues
Sites / Locations
- Department of Biomedical Engineering, The Chinese University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Dual-task Group
Cycling Group
Cognitive Group
Arm Description
Outcomes
Primary Outcome Measures
The Montreal Cognitive Assessment, Hong Kong Version (HK-MoCA)
Secondary Outcome Measures
Trail Making Test
6 Minutes Walk Test
5 times Sit to Stand
10 meters walk Test
Graded Heart-rate Assessment
Full Information
NCT ID
NCT05384639
First Posted
May 17, 2022
Last Updated
May 19, 2022
Sponsor
Chinese University of Hong Kong
Collaborators
Innovation and Technology Commission, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05384639
Brief Title
Dual-task Cycling System on Cognitive Function for the Elderly
Official Title
Simultaneous Dual-Task Cycling Exercise Training on Cognitive Function for the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Innovation and Technology Commission, Hong Kong
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
This project aims to develop a new dual-task stationary cycling system that can monitor and provide feedback on the aerobic exercise intensity, while administrating appropriate cognitive trainings targeting various cognitive sub domains through a screen in front of the user.
The proposed system is designed to train the brain with cognitive tasks and the body with aerobic exercises at the same time. The difficulties of the cognitive tasks are controlled by the users' previous performances on these tasks so that they wouldn't be too easy nor too difficult. Similarly, the intensity of the aerobic exercise will be monitored through an optical encoder for the cycling cadence, two power meters for the force output on the two pedals, as well as a heart rate monitor for the users' physiological response. Constant feedback is being provided to the users so that they will exercise at the correct intensity to provide the greater cardiovascular and cognitive benefits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dual-task Group
Arm Type
Experimental
Arm Title
Cycling Group
Arm Type
Active Comparator
Arm Title
Cognitive Group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Dual-task Group
Intervention Description
Participant will cycle and perform cognitive training simultaneously.
Intervention Type
Device
Intervention Name(s)
Cycling Group
Intervention Description
Participant will cycle only.
Intervention Type
Device
Intervention Name(s)
Cognitive Group
Intervention Description
Participant will perform cognitive training only.
Primary Outcome Measure Information:
Title
The Montreal Cognitive Assessment, Hong Kong Version (HK-MoCA)
Time Frame
Within one month after the last training session
Secondary Outcome Measure Information:
Title
Trail Making Test
Time Frame
Within one month after the last training session
Title
6 Minutes Walk Test
Time Frame
Within one month after the last training session
Title
5 times Sit to Stand
Time Frame
Within one month after the last training session
Title
10 meters walk Test
Time Frame
Within one month after the last training session
Title
Graded Heart-rate Assessment
Time Frame
Within one month after the last training session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of MCI or cutoff at 2 < n < 16 th percentile MoCA score according to the level of education and age
Sufficient cognitive ability to follow simple instructions
Able to understand content and purpose of the study
Conscious and in stable physical condition
Exclusion Criteria:
Any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopaedic or chronic pain condition; or
Severe hip, knee or ankle contracture that would preclude the passive range of motion of the leg
Uncontrolled Cardiac issues
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond Tong, PhD
Phone
+85239438454
Email
kytong@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Tong, PhD
Organizational Affiliation
Department of Biomedical Engineering, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biomedical Engineering, The Chinese University of Hong Kong
City
Shatin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Tong, PhD
Phone
+852 3943 8454
Email
kytong@cuhk.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
No
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Dual-task Cycling System on Cognitive Function for the Elderly
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