Cognitive ImpairmentNCT05384639
Dual-task Cycling System on Cognitive Function for the Elderly
A study testing Dual-task Group, Cycling Group and Cognitive Group in people with Cognitive Impairment, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Dual-task Group, Cycling Group and Cognitive Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 27 Jan 2021to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Biomedical Engineering, The Chinese University of Hong Kong
Shatin
Raymond Tong, PhD, +852 3943 8454, kytong@cuhk.edu.hk
About this study
Official title: 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.
- Conditions
- Cognitive Impairment
- Being tested
- Dual-task Group, Cycling Group, Cognitive Group
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-task GroupDevice
Participant will cycle and perform cognitive training simultaneously.
Cycling GroupDevice
Participant will cycle only.
Cognitive GroupDevice
Participant will perform cognitive training only.
| Study group | Role | What they receive |
|---|---|---|
| Dual-task Group | Experimental | Not described Receives: Device: Dual-task Group |
| Cycling Group | Active comparator | Not described Receives: Device: Cycling Group |
| Cognitive Group | Active comparator | Not described Receives: Device: Cognitive Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Montreal Cognitive Assessment, Hong Kong Version (HK-MoCA)
Measured: Within one month after the last training session
Secondary outcomes (5)
Trail Making Test
Measured: Within one month after the last training session
6 Minutes Walk Test
Measured: Within one month after the last training session
5 times Sit to Stand
Measured: Within one month after the last training session
10 meters walk Test
Measured: Within one month after the last training session
Graded Heart-rate Assessment
Measured: Within one month after the last training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start27 Jan 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation and Technology Commission, Hong Kong
- Responsible party
- Principal investigator, Raymond KY Tong, Chinese University of Hong Kong
- Investigators
- Raymond Tong, PhD, Principal investigator, Department of Biomedical Engineering, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384639
- Sponsor's protocol ID
- 2020.319
- Status last verified
- May 2022
- First submitted
- 17 May 2022
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Dual-Task Cycling Exercise Training on Cognitive Function for the Elderly
- ClinicalTrials.gov ID
- NCT05384639
- Acronym / sponsor ID
- 2020.319
- Conditions
- Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Innovation and Technology Commission, Hong Kong
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dual-task Group | Experimental | Device: Dual-task Group |
| Cycling Group | Active comparator | Device: Cycling Group |
| Cognitive Group | Active comparator | Device: Cognitive Group |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-task GroupParticipant will cycle and perform cognitive training simultaneously. | Device | Dual-task Group |
| Cycling GroupParticipant will cycle only. | Device | Cycling Group |
| Cognitive GroupParticipant will perform cognitive training only. | Device | Cognitive Group |
Primary outcome
The Montreal Cognitive Assessment, Hong Kong Version (HK-MoCA)
Time frame: Within one month after the last training session
5 secondary outcomes
Trail Making Test
Time frame: Within one month after the last training session
6 Minutes Walk Test
Time frame: Within one month after the last training session
5 times Sit to Stand
Time frame: Within one month after the last training session
10 meters walk Test
Time frame: Within one month after the last training session
Graded Heart-rate Assessment
Time frame: Within one month after the last training session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Tong, PhD principal investigator
Department of Biomedical Engineering, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-task Group, Cycling Group and Cognitive Group in people with Cognitive Impairment, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raymond Tong, PhD (+85239438454, kytong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Montreal Cognitive Assessment, Hong Kong Version (HK-MoCA) (time frame: Within one month after the last training session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.