E-health Brisk Walking in Older People With Cognitive Frailty

Cognitive Frailty Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05758740
• Other study ID #: UGC/FDS17/H04/22
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2023
• Source: Tung Wah College
• Contact: Rick Kwan, PhD
• Phone: 852-34686813
• Email: rickkwan[@]twc.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 184
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Frailty
• Frailty

Intervention

Behavioral:
• E-health enhanced behavioural change intervention
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 intervention
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Tung Wah College	The Hong Kong Polytechnic University, University of Southampton

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 weeks
Primary	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.	6 months
Secondary	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.	14 weeks
Secondary	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.	6 months
Secondary	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.	14 weeks
Secondary	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.	6 months
Secondary	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.	14 weeks
Secondary	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.	6 months
Secondary	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.	14 weeks
Secondary	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.	6 months
Secondary	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.	14 weeks
Secondary	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.	6 months