UnknownNot Applicable

E-health Brisk Walking in Older People With Cognitive Frailty

184 participantsStarted 2023-04-01

Plain-language 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. 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 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.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 14 weeks

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

Timeframe: 6 months

Trial details

NCT IDNCT05758740

SponsorTung Wah College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30

Contact for this trial

Rick Kwan, PhD

852-34686813 rickkwan@twc.edu.hk

View on ClinicalTrials.gov More Cognitive Frailty trials