NCT05384639

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

1.4 years

First QC Date

May 17, 2022

Last Update Submit

May 19, 2022

Conditions

Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • The Montreal Cognitive Assessment, Hong Kong Version (HK-MoCA)

    Within one month after the last training session

Secondary Outcomes (5)

  • 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

Study Arms (3)

Dual-task Group

EXPERIMENTAL
Device: Dual-task Group

Cycling Group

ACTIVE COMPARATOR
Device: Cycling Group

Cognitive Group

ACTIVE COMPARATOR
Device: Cognitive Group

Interventions

Dual-task GroupDEVICE

Participant will cycle and perform cognitive training simultaneously.

Dual-task Group
Cycling GroupDEVICE

Participant will cycle only.

Cycling Group
Cognitive GroupDEVICE

Participant will perform cognitive training only.

Cognitive Group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Raymond Tong, PhD

    Department of Biomedical Engineering, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Tong, PhD

CONTACT

+85239438454kytong@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chairman

Study Record Dates

First Submitted

May 17, 2022

First Posted

May 20, 2022

Study Start

January 27, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

May 23, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)