Dual-task Cycling System on Cognitive Function for the Elderly

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05384639
• Other study ID #: 2020.319
• Status: Recruiting
• Phase: N/A
• Start date: January 27, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: May 2022
• Source: Chinese University of Hong Kong
• Contact: Raymond Tong, PhD
• Phone: +85239438454
• Email: kytong[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Device:
• Dual-task Group
Participant will cycle and perform cognitive training simultaneously.
• Cycling Group
Participant will cycle only.
• Cognitive Group
Participant will perform cognitive training only.

Locations

Country	Name	City	State
Hong Kong	Department of Biomedical Engineering, The Chinese University of Hong Kong	Shatin

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Innovation and Technology Commission, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Montreal Cognitive Assessment, Hong Kong Version (HK-MoCA)		Within one month after the last training session
Secondary	Trail Making Test		Within one month after the last training session
Secondary	6 Minutes Walk Test		Within one month after the last training session
Secondary	5 times Sit to Stand		Within one month after the last training session
Secondary	10 meters walk Test		Within one month after the last training session
Secondary	Graded Heart-rate Assessment		Within one month after the last training session