FrailtyNCT05750121
E-health Enhanced Motor-cognitive Training for AED Discharged Older Adults With Cognitive Frailty
A study testing E-health enhanced motor-cognitive training in people with Frailty and Mild Cognitive Impairment, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The goal of this pilot randomized controlled trial is to explore the feasibility of e-health enhanced motor-cognitive interventions for discharged community-dwelling older adults with cognitive frailty in the emergency department and to evaluate the effectiveness of the interventions on (1) cognitive functions, (2)… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frailty, Mild Cognitive Impairment
- What is being tested?
- E-health enhanced motor-cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 Mar 2023to 1 Jan 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60 years old or above;
- discharged from the AED;
- Cantonese speaking;
- have a smartphone and have experience in using the smartphone for at least six months;
- with cognitive frailty, the coexistence of mild cognitive impairment (MCI) and physical frailty, without being diagnosed as dementia.
Who cannot join
- unable to make consent,
- unable to communicate due to language barrier or visual impairment or uncorrectable hearing impairment,
- old aged home residents,
- already participated in other interventional studies,
- participate in any geriatric program and training, or
- impaired mobility
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
School of Nursing, The Hong Kong Polytechnic University
Hong Kong
Daphne Cheung, PhD, +852 27664534, daphne.cheung@polyu.edu.hk
Rick Kwan, PhD
About this study
Official title: Effects of E-health Enhanced Motor-cognitive Training on Cognitive Functions, Physical Frailty and Physical Functions of Accident and Emergency Department Discharged Community-dwelling Older Adults With Cognitive Frailty: A Pilot Trial
The goal of this pilot randomized controlled trial is to explore the feasibility of e-health enhanced motor-cognitive interventions for discharged community-dwelling older adults with cognitive frailty in the emergency department and to evaluate the effectiveness of the interventions on (1) cognitive functions, (2) physical functions and (3) frailty status.
Participants in the intervention group will receive three-90-minute weekly physical and cognitive training for 12 weeks, facilitated with persuasive technology on smartphones, in addition to the usual care. The control group will receive the usual care. Researchers will explore the feasibility and compare the changes of outcomes between two groups.
Read the detailed description
Motor-cognitive training effectively reverses and prevents further deterioration of cognitive function, frailty status, and physical function in older adults with cognitive frailty. Recent systematic reviews showed that older adults with cognitive frailty are more likely to develop dementia and have falls than those with frailty alone. The current time-pressured Accident and Emergency Department (AED) setting is challenging for the practitioners to have an intervention to maintain or improve the current physical and cognitive function of these older adults with non-acute complaints and prone to further deteriorate after being discharged from AED. There is a mismatch of services in traditional emergency medicine with the demand of the elderly population. Particular intervention for these older adults is needed. Based on the systematic review and the previous literature, motor-cognitive training is an essential intervention component. Interventions in a home setting can increase flexibility and improve adherence to the intervention. However, the effect on motor-cognitive training in a home setting is unknown. This study aims to explore the feasibility of e-health enhanced motor-cognitive interventions for discharged community-dwelling older adults with cognitive frailty in the emergency department and to evaluate the effectiveness of the interventions on (1) cognitive functions, (2) physical functions and (3) frailty status.
This study is a single-blinded pilot randomised, controlled study. Subjects will be allocated to either the intervention or control group by a 1:1 ratio, where they will receive motor-cognitive training in addition to usual care or usual care only. The program will be targeted older adults aged 60 or above with cognitive frailty and discharged from AED. The intervention lasts for 12 weeks, with three 90 minutes sessions (60 minutes of physical activity and 30 minutes of cognitive training) per week. Trained emergency nurses will provide respective assessments and interventions separately. The primary outcomes are to check the feasibility, including compliance, adherence and adverse effect of the study. Intervention efficacy is the secondary outcome, including physical frailty level, physical performance, and cognitive function. Fried Frailty Index will measure frailty level, physical performance will be measured by Timed-Up-Go Test, handgrip strength, gait speed, chair stand test, arm curl test and Physical Activity Scale for the Elderly. Montreal cognitive assessment (MoCA), Fuld object-memory evaluation (FOME), trail making test (TMT) will be used to measure the cognitive functions. Secondary outcome indicators included. Data will be collected in two-time points, baseline and post-intervention Findings of the study can help in improving the actual research and providing evidence for implementing motor-cognitive training for AED-discharged older adults with cognitive frailty.
- Conditions
- Frailty, Mild Cognitive Impairment
- Being tested
- E-health enhanced motor-cognitive training
- Keywords
- Cognitive frailty, Motor-Cognitive Training, Older Adults, Discharged
- Medical subject headings
- Frailty, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-health enhanced motor-cognitive trainingBehavioural
The intervention group will implement physical activity (aerobic exercise and resistance training) and cognitive training (CogniFit) intervention with the e-health components (persuasive technology). The intervention period will last for 12 weeks, with three 90 minutes sessions (60 minutes of physical activity and 30 minutes of cognitive training) per week.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | The intervention group will receive home-based motor-cognitive training and usual emergency care. Receives: Behavioral: E-health enhanced motor-cognitive training |
| Usual care group | No intervention | Usual care includes wound care, community nurse service, medications and on-site physiotherapy, occupational therapy, community nurse service, medical social work service, and geriatric nurse follow-up service will be referred when necessary. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
One of the feasibility outcomes. It is the overall recruitment rate, which will be calculated by dividing the number of recruited and randomized, by the total invited eligible potential participants. It will range from 0 to 100%.
Measured: At baseline
Retention rate
One of the feasibility outcomes. It is calculated by dividing the number of randomised participants retained and assessed with valid primary outcome data at the end of the project, by the recruited participants. It will range from 0 to 100%.
Measured: At the 12th - 14th week (post-intervention)
Adverse events
A feasibility indicators, which is defined as an undesired effect of the intervention. Any adverse events reported by the participants will be documented and reported.
Measured: Continuous monitoring throughout the 12 weeks of intervention
Secondary outcomes (11)
Global cognition
It will be assessed with the Hong Kong version Montreal of Cognitive Assessment. The total score of the instrument ranges from 0 - 30. Higher score indicates better cognitive functions.
Measured: At baseline, and the 12th - 14th week (post intervention)
Memory
It will be measured with Fuld Object Memory Evaluation. It consists of three subscores, namely the total storage, total retrieval and delayed recall with the highest possible scores of 50, 50, and 10 respectively. Higher the scores indicate better cognitive functions.
Measured: At baseline, and the 12th - 14th week (post intervention)
Visual attention and task switching
It will be measured with the Trail Making Test (TMT), which consists of two parts: TMT-A and TMT-B. Shorter the time used indicates better cognitive functions.
Measured: At baseline, and the 12th - 14th week (post intervention)
Mobility
It will be measured with the Time-up-and-Go test. It represents the total time needed for the participants to stand and walk for 3 meters, turn around and walk back to the chair and sit down. Shorter the time used indicates better monility.
Measured: At baseline, and the 12th - 14th week (post intervention)
Gait speed
The time used for the 6-meter walk, shorter the time used indicates better gait speed.
Measured: At baseline, and the 12th - 14th week (post intervention)
Leg strength and endurance
It will be assessed with the Chair Stand Test. The participants will be required to stand up repeatedly from a chair for 30 seconds. The higher number of stands a person can complete in 30 seconds, indicates a better leg strength and endurance.
Measured: At baseline, and the 12th - 14th week (post intervention)
Physical activity
It will be measured with the Physical Activity Scale for the Elderly, which quantify the amount of daily physical activity. The total score ranges from 0 to 793, with a higher score indicates a larger amount of physical activity.
Measured: At baseline, and the 12th - 14th week (post intervention)
Hand-grip strength
It will be measured with a handgrip dyanometer.
Measured: At baseline, and the 12th - 14th week (post intervention)
Strength of upper extremities
It will be measured with the Arm-Curl Test. The number of bicep curls in 30 seconds while holding a hand weight.
Measured: At baseline, and the 12th - 14th week (post intervention)
Actigraph data
Data will be collected with a wrist worn Actigraph GT3X+ device.
Measured: Throughout the 12 weeks intervention period.
Frailty status
The Fried Frailty Index will be used to measure the frailty status. The total score ranges from 0 to five. Higher score indicates a higher frailty level. Score 0, 1-2, and 3-5 correspond to robust, pre-frail, and frail respectively.
Measured: At baseline, and the 12th - 14th week (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start23 Mar 2023
- Primary completion29 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Tung Wah College, Hospital Authority, Hong Kong
- Responsible party
- Principal investigator, Dr Daphne Cheung, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750121
- Sponsor's protocol ID
- HSEARS20220307001
- Status last verified
- Sep 2023
- First submitted
- 19 Jan 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of E-health Enhanced Motor-cognitive Training on Cognitive Functions, Physical Frailty and Physical Functions of Accident and Emergency Department Discharged Community-dwelling Older Adults With Cognitive Frailty: A Pilot Trial
- ClinicalTrials.gov ID
- NCT05750121
- Acronym / sponsor ID
- HSEARS20220307001
- Conditions
- Frailty, Mild Cognitive Impairment
- Keywords
- Cognitive frailty, Motor-Cognitive Training, Older Adults, Discharged
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Tung Wah College, Hospital Authority, Hong Kong
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 29 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 1 Mar 2023 (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.
The goal of this pilot randomized controlled trial is to explore the feasibility of e-health enhanced motor-cognitive interventions for discharged community-dwelling older adults with cognitive frailty in the emergency department and to evaluate the effectiveness of the interventions on (1) cognitive functions, (2) physical functions and (3) frailty status.
Participants in the intervention group will receive three-90-minute weekly physical and cognitive training for 12 weeks, facilitated with persuasive technology on smartphones, in addition to the usual care. The control group will receive the usual care. Researchers will explore the feasibility and compare the changes of outcomes between two groups.
Detailed description
Motor-cognitive training effectively reverses and prevents further deterioration of cognitive function, frailty status, and physical function in older adults with cognitive frailty. Recent systematic reviews showed that older adults with cognitive frailty are more likely to develop dementia and have falls than those with frailty alone. The current time-pressured Accident and Emergency Department (AED) setting is challenging for the practitioners to have an intervention to maintain or improve the current physical and cognitive function of these older adults with non-acute complaints and prone to further deteriorate after being discharged from AED. There is a mismatch of services in traditional emergency medicine with the demand of the elderly population. Particular intervention for these older adults is needed. Based on the systematic review and the previous literature, motor-cognitive training is an essential intervention component. Interventions in a home setting can increase flexibility and improve adherence to the intervention. However, the effect on motor-cognitive training in a home setting is unknown. This study aims to explore the feasibility of e-health enhanced motor-cognitive interventions for discharged community-dwelling older adults with cognitive frailty in the emergency department and to evaluate the effectiveness of the interventions on (1) cognitive functions, (2) physical functions and (3) frailty status.
This study is a single-blinded pilot randomised, controlled study. Subjects will be allocated to either the intervention or control group by a 1:1 ratio, where they will receive motor-cognitive training in addition to usual care or usual care only. The program will be targeted older adults aged 60 or above with cognitive frailty and discharged from AED. The intervention lasts for 12 weeks, with three 90 minutes sessions (60 minutes of physical activity and 30 minutes of cognitive training) per week. Trained emergency nurses will provide respective assessments and interventions separately. The primary outcomes are to check the feasibility, including compliance, adherence and adverse effect of the study. Intervention efficacy is the secondary outcome, including physical frailty level, physical performance, and cognitive function. Fried Frailty Index will measure frailty level, physical performance will be measured by Timed-Up-Go Test, handgrip strength, gait speed, chair stand test, arm curl test and Physical Activity Scale for the Elderly. Montreal cognitive assessment (MoCA), Fuld object-memory evaluation (FOME), trail making test (TMT) will be used to measure the cognitive functions. Secondary outcome indicators included. Data will be collected in two-time points, baseline and post-intervention Findings of the study can help in improving the actual research and providing evidence for implementing motor-cognitive training for AED-discharged older adults with cognitive frailty.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: E-health enhanced motor-cognitive trainingThe intervention group will receive home-based motor-cognitive training and usual emergency care. |
| Usual care group | No intervention | –Usual care includes wound care, community nurse service, medications and on-site physiotherapy, occupational therapy, community nurse service, medical social work service, and geriatric nurse follow-up service will be referred when necessary. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 60 years old or above;
- discharged from the AED;
- Cantonese speaking;
- have a smartphone and have experience in using the smartphone for at least six months;
- with cognitive frailty, the coexistence of mild cognitive impairment (MCI) and physical frailty, without being diagnosed as dementia.
Key exclusion criteria (6 listed)
- unable to make consent,
- unable to communicate due to language barrier or visual impairment or uncorrectable hearing impairment,
- old aged home residents,
- already participated in other interventional studies,
- participate in any geriatric program and training, or
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 |
|---|---|---|
| E-health enhanced motor-cognitive trainingThe intervention group will implement physical activity (aerobic exercise and resistance training) and cognitive training (CogniFit) intervention with the e-health components (persuasive technology). The intervention period will last for 12 weeks, with three 90 minutes sessions (60 minutes of physical activity and 30 minutes of cognitive training) per week. | Behavioural | Treatment group |
Primary outcome
Recruitment rate
Time frame: At baseline
One of the feasibility outcomes. It is the overall recruitment rate, which will be calculated by dividing the number of recruited and randomized, by the total invited eligible potential participants. It will range from 0 to 100%.
Retention rate
Time frame: At the 12th - 14th week (post-intervention)
One of the feasibility outcomes. It is calculated by dividing the number of randomised participants retained and assessed with valid primary outcome data at the end of the project, by the recruited participants. It will range from 0 to 100%.
Adverse events
Time frame: Continuous monitoring throughout the 12 weeks of intervention
A feasibility indicators, which is defined as an undesired effect of the intervention. Any adverse events reported by the participants will be documented and reported.
11 secondary outcomes
Global cognition
Time frame: At baseline, and the 12th - 14th week (post intervention)
Memory
Time frame: At baseline, and the 12th - 14th week (post intervention)
Visual attention and task switching
Time frame: At baseline, and the 12th - 14th week (post intervention)
Mobility
Time frame: At baseline, and the 12th - 14th week (post intervention)
Gait speed
Time frame: At baseline, and the 12th - 14th week (post intervention)
Leg strength and endurance
Time frame: At baseline, and the 12th - 14th week (post intervention)
Physical activity
Time frame: At baseline, and the 12th - 14th week (post intervention)
Hand-grip strength
Time frame: At baseline, and the 12th - 14th week (post intervention)
Strength of upper extremities
Time frame: At baseline, and the 12th - 14th week (post intervention)
Actigraph data
Time frame: Throughout the 12 weeks intervention period.
Frailty status
Time frame: At baseline, and the 12th - 14th week (post intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-health enhanced motor-cognitive training in people with Frailty and Mild Cognitive Impairment, run by The Hong Kong Polytechnic University 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 5 inclusion and 6 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 28 Sep 2023. 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 Daphne Cheung, PhD (+852 27664534, daphne.cheung@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: At baseline). The study lists 3 primary outcomes in all. 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 28 Sep 2023.