Dual-task Cycling System on Cognitive Function for the Elderly

Simultaneous Dual-Task Cycling Exercise Training on Cognitive Function for the Elderly

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment
• Intervention / Treatment: Device: Dual-task Group; Device: Cycling Group; Device: Cognitive Group

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raymond Tong, PhD; Phone Number: +85239438454; Email: kytong@cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Recruiting
    • Department of Biomedical Engineering, The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dual-task Group	Device: Dual-task Group; Participant will cycle and perform cognitive training simultaneously.
Active Comparator: Cycling Group	Device: Cycling Group; Participant will cycle only.
Active Comparator: Cognitive Group	Device: Cognitive Group; Participant will perform cognitive training only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Montreal Cognitive Assessment, Hong Kong Version (HK-MoCA)	Within one month after the last training session

Secondary Outcome Measures

Outcome Measure	Time Frame
Trail Making Test	Within one month after the last training session
6 Minutes Walk Test	Within one month after the last training session
5 times Sit to Stand	Within one month after the last training session
10 meters walk Test	Within one month after the last training session
Graded Heart-rate Assessment	Within one month after the last training session

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Innovation and Technology Commission, Hong Kong
• Investigators: Principal Investigator: Raymond Tong, PhD, Department of Biomedical Engineering, The Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2020.319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No