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Cognitive FrailtyNCT05758740

E-health Brisk Walking in Older People With Cognitive Frailty

A study testing E-health enhanced behavioural change intervention and Conventional behavioural change intervention in people with Cognitive Frailty, run by Tung Wah College at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Introduction Cognitive frailty is common in community-dwelling older people and is an at-risk state for adverse health outcomes such as dementia, dependency, and mortality. Fortunately, cognitive frailty is reversible, with a higher probability of reversibility at earlier stages. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Cognitive Frailty
What is being tested?
E-health enhanced behavioural change intervention and Conventional behavioural change intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
1 siteHong Kong
Study dates
1 Apr 2023to 30 Sep 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

  • 1) aged ≥ 60 years, because the WHO defines older people in Asia as those aged 60 or older;
  • 2) presence of cognitive frailty, defined as the co-existence of MCI and frailty at either the pre-frail or the frail level;
  • 3) physical inactivity, defined as < 150 min of MVPA every week in the 4 weeks preceding the study, as confirmed by a Rapid Assessment of Physical Activity (RAPA) score of ≤ 4 (i.e., regularly underactive);
  • 4) possession of a smartphone on which Samsung Health and WhatsApp can be installed for > 6 months; and
  • 5) being a Cantonese speaker, defined as possessing the ability to communicate in Cantonese.

Who cannot join

  • 1) impaired mobility caused by conditions that require medication (e.g., severe arthritis) and inability to walk briskly outdoors, as defined by a modified Functional Ambulatory Classification score of < 7);
  • 2) depressive symptomatology, as defined by a Geriatric Depression Scale (GDS) score of ≥ 8;67
  • 3) having probable dementia (i.e., a Montreal Cognitive Assessment [MoCA] score of < 20 or Clinical Dementia Rating [CDR] score of ≥ 1),
  • 4) being physically unfit because of chronic illness, as defined by a Physical Activity Readiness Questionnaire (PAR-Q) score of ≥ 1, and not having been examined by a medical doctor and certified as physically fit to participate in brisk walking;
  • 5) not enrolled in any other interventions to promote physical activity or training

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Tung Wah Collage

    Hong Kong

Other trials in Hong Kong

About this study

Official title: The Effectiveness of an E-health Brisk Walking Intervention in Increasing Moderate to Vigorous Physical Activity in Physically Inactive Older People With Cognitive Frailty: A Randomised Controlled Trial

Introduction Cognitive frailty is common in community-dwelling older people and is an at-risk state for adverse health outcomes such as dementia, dependency, and mortality. Fortunately, cognitive frailty is reversible, with a higher probability of reversibility at earlier stages. Physical activity is known to play a significant role in reversing cognitive frailty; its effect is moderated by intensity and sustainability. However, physical inactivity is very common in older people and is one of the key phenotypical characteristics of cognitive frailty. Moderate to vigorous physical activity (MVPA) can reduce the risk of worsening cognitive frailty. Brisk walking is a simple form of exercise that can be practised by community-dwelling older people every day to boost their physical activity to or above a moderate intensity level. Conventional behavioural change interventions (CBCIs) have been shown to effectively engage sedentary older people in physical activity, but their effect size is small. The use of e-health methods that adopt existing and popular e-platforms (e.g., Samsung Health and WhatsApp) to promote specific behaviours (e.g., regular brisk walking) in specific groups (e.g., older people with cognitive frailty) is an innovative, practically feasible and theoretically sound method of increasing MVPA. However, the relative effectiveness of e-health interventions and CBCIs in vulnerable groups (i.e., older people with cognitive frailty) is unknown.

Objectives The objectives of this study are to compare the effectiveness of an e-health intervention and a conventional behavioural change intervention in older people with cognitive frailty in improving 1) moderate-to-vigorous physical activity, 2) reducing cognitive frailty, 3) improving cognitive function, 4) improving walking speed, 5) improving functional fitness, and 6) improving physical activity motivation

Read more

Methods A single-blinded, two-parallel-group, non-inferiority, randomised controlled trial will be conducted in a community setting. Subjects will be recruited from five elderly community centres in Hong Kong. The eligibility criteria will be as follows: (1) aged ≥ 60, (2) cognitively frail, (3) physically inactive and (4) possessing a smartphone. The participants in the intervention group will receive an e-health intervention. Those in the control group will receive a CBCI. Each intervention will last for 14 weeks. The outcomes will be MVPA min/week (primary), as measured by a wrist-worn ActiGraph; cognitive frailty, as measured by an ordinal scale; cognitive function, as measured by the Montreal Cognitive Assessment; and frailty, as measured by the Fried frailty phenotype (FFP). The outcomes will be assessed at T0 (baseline), T1 (immediately post-intervention) and T2 (6 months post-intervention). The investigators plan to recruit 192 subjects. Permuted block randomisation with randomly selected block sizes in a ratio of 1:1 will be used. Only the outcome assessors will be blinded. Four generalised estimating equations will be used to test the effects of the interventions on the four outcomes, which will be the dependent variables. The independent variables will be group, time and [group] × [time]. The level of significance will be set at 0.05.

Significance If the e-health intervention proves to be more effective and sustainable than the CBCI, There will be evidence suggesting that e-health interventions can replace CBCIs in promoting MVPA and treating cognitive frailty in older people in community settings. Further studies could then examine the potential role of e-health interventions in delaying the onset of dementia and dependency.

Being tested
E-health enhanced behavioural change intervention, Conventional behavioural change intervention
Keywords
e-health, brisk walking, moderate-to-vigorous physical activity, physical inactivity
Medical subject headings
Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E-health enhanced behavioural change interventionBehavioural

    Participants will first receive a face-to-face brisk-walking training programme with lectures and demonstrations following a standardized brisk training content. The training will be provided face-to-face at the elderly community centres and parks. Each training session lasts for one hour and is two times per week for two weeks. After that, a conventional behavioural change intervention will begin following a standardized intervention implementation manual and the physical activity amount will be logged by the participants using a logbook. Physical activity counselling will be conducted by a trained research assistant face-to-face at the elderly community centre. Each counselling session lasts for one hour and is once per week for 12 weeks.

  • Conventional behavioural change interventionBehavioural

    Participants will first receive a face-to-face brisk-walking training programme with lectures and demonstrations following a standardized brisk training content. The training will be provided face-to-face at the elderly community centres and parks. Each training session lasts for one hour and is two times per week for two weeks. After that, e-health enhanced behavioural change intervention will begin following a standardized intervention implementation manual and using participants' own smartphones installed with two Apps (i.e., Samsung Health and WhatsApp). The physical activity amount will be logged by the smartphone using Samsung Health. Physical activity counselling will be conducted by a trained research assistant remotely using a smartphone. The remote counselling sessions totally last for accumulatively 1 hour per week for 12 weeks.

Study groups in NCT05758740
Study groupRoleWhat they receive
E-health enhanced behavioural change interventionExperimentalThe investigators will administer e-health behavioural change techniques (e.g., automated advice, tele-counselling, digital-tailored advice) on top of the conventional behavioural change techniques (e.g., information provision, goal setting) via digital devices (i.e., smartphone) to promote moderate-to-vigorous physical activity of the participants.
Receives: Behavioral: E-health enhanced behavioural change intervention
Conventional behavioural change interventionActive comparatorThe investigators will administer conventional behavioural change techniques (e.g., information provision, goal setting) via conventional methods (i.e., face-to-face meetings) to promote moderate-to-vigorous physical activity of the participants.
Receives: Behavioral: Conventional behavioural change intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Moderate-to-vigorous physical activity (MVPA) minute, measured by Actigraph

    ActiGraph mounted on the right wrist measures physical movement (i.e., vector magnitude) that counts an MVPA minute when it has measured 4,212.9 counts within a minute. Only at least 10 min of continuous MVPA will be counted as valid MVPA minutes. This variable measures valid MVPA minutes accumulated over 7 consecutive days.

    Measured: 14 weeks

  2. Moderate-to-vigorous physical activity (MVPA) minute, measured by Actigraph

    ActiGraph mounted on the right wrist measures physical movement (i.e., vector magnitude) that counts an MVPA minute when it has measured 4,212.9 counts within a minute. Only at least 10 min of continuous MVPA will be counted as valid MVPA minutes. This variable measures valid MVPA minutes accumulated over 7 consecutive days.

    Measured: 6 months

Secondary outcomes (10)
  1. Cognitive frailty, measured by a 6-point scale of Cognitive Frailty

    Cognitive frailty comprises six combinations of two components: frailty (robust, pre-frail, and frail) and mild cognitive impairment (yes, no). The scale quantifies cognitive frailty at six levels: 0 for "robust without mild cognitive impairment", 1 for "pre-frail without mild cognitive impairment", 2 for "frail without mild cognitive impairment", 3 for "non-frail with mild cognitive impairment", 4 for "pre-frail with mild cognitive impairment" and 5 for "frailty with mild cognitive impairment". A higher score will indicate greater severity of cognitive frailty.

    Measured: 14 weeks

  2. Cognitive frailty, measured by a 6-point scale of Cognitive Frailty

    Cognitive frailty comprises six combinations of two components: frailty (robust, pre-frail, and frail) and mild cognitive impairment (yes, no). The scale quantifies cognitive frailty at six levels: 0 for "robust without mild cognitive impairment", 1 for "pre-frail without mild cognitive impairment", 2 for "frail without mild cognitive impairment", 3 for "non-frail with mild cognitive impairment", 4 for "pre-frail with mild cognitive impairment" and 5 for "frailty with mild cognitive impairment". A higher score will indicate greater severity of cognitive frailty.

    Measured: 6 months

  3. Cognitive function, measured by Montreal Cognitive Assessment

    Montreal Cognitive Assessment comprises 30 dichotomous items. One point will be assigned to one correct answer. The total score ranges from 0 to 30. A higher score indicates a higher level of cognitive function.

    Measured: 14 weeks

  4. Cognitive function, measured by Montreal Cognitive Assessment

    Montreal Cognitive Assessment comprises 30 dichotomous items. One point will be assigned to one correct answer. The total score ranges from 0 to 30. A higher score indicates a higher level of cognitive function.

    Measured: 6 months

  5. Walking speed, measured by Timed Up-and-Go Test

    Timed Up-and-Go test measures the total time needed for a participant to stand up from a chair, walk a 3-metre distance, walk back to the chair, and sit down. A longer time needed to complete the test indicates a slower walking speed.

    Measured: 14 weeks

  6. Walking speed, measured by Timed Up-and-Go Test

    Timed Up-and-Go test measures the total time needed for a participant to stand up from a chair, walk a 3-metre distance, walk back to the chair, and sit down. A longer time needed to complete the test indicates a slower walking speed.

    Measured: 6 months

  7. Functional fitness, measured by 30-second Chair Stand Test

    30-second Chair Stand Test measures the number of stands a person can complete in 30 seconds. A higher number of stands completed within the given 30 seconds indicates a higher level of functional fitness.

    Measured: 14 weeks

  8. Functional fitness, measured by 30-second Chair Stand Test

    30-second Chair Stand Test measures the number of stands a person can complete in 30 seconds. A higher number of stands completed within the given 30 seconds indicates a higher level of functional fitness.

    Measured: 6 months

  9. Physical activity motivation, measured by Revised Motivation for Physical Activity Measure

    Revised Motivation for Physical Activity Measure comprises 30 7-point items with a total score ranging from 30 to 210. A higher score indicates greater motivation to perform physical activity.

    Measured: 14 weeks

  10. Physical activity motivation, measured by Revised Motivation for Physical Activity Measure

    Revised Motivation for Physical Activity Measure comprises 30 7-point items with a total score ranging from 30 to 210. A higher score indicates greater motivation to perform physical activity.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2023
  2. Study start1 Apr 2023
  3. Primary completion29 Aug 2025
  4. Study completion30 Sep 2025

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05758740
Sponsor's protocol ID
UGC/FDS17/H04/22
Status last verified
Feb 2023
First submitted
13 Feb 2023
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data will be provided upon other researchers' requests

Publications

  • Kwan RYC, Liu JYW, Lee PH, Sin OSK, Wong JSW, Fu MR, Suen LKP. The effects of an e-health brisk walking intervention in increasing moderate-to-vigorous physical activity in physically inactive older people with cognitive frailty: study protocol for a randomized controlled trial. Trials. 2023 May 17;24(1):339. doi: 10.1186/s13063-023-07335-8.

    PubMed 37198670

Questions about this trial

What is this clinical trial studying?

A study testing E-health enhanced behavioural change intervention and Conventional behavioural change intervention in people with Cognitive Frailty, run by Tung Wah College 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 5 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: finished, as of the sponsor's last update on 2 Nov 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Moderate-to-vigorous physical activity (MVPA) minute, measured by Actigraph (time frame: 14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05758740, which also lists 1 linked publication.

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 2 Nov 2026.

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