ABSTRACT
BACKGROUND: Cognitive frailty is a risk for many adverse health outcomes that are commonly observed in older people. Physical activity is known to be effective to reserve cognitive frailty but the prevalence of physical inactivity is still high in older people. E-health enhances behavioural change effects through an innovative way to deliver behavioural change methods that can enhance the behavioural change effects. However, its effects on older people with cognitive frailty, its effects compared with conventional behavioural change methods, and the sustainability of the effects are unclear. METHODS: This study employs a single-blinded, two-parallel-group, non-inferiority, randomized controlled trial design with a 1:1 group allocation ratio. Eligible participants are aged 60 years or above, have cognitive frailty and physical inactivity, and possess a smartphone for more than six months. The study will be conducted in community settings. In the intervention group, participants will receive a 2-week brisk-walking training followed by a 12-week e-health intervention. In the control group, participants will receive a 2-week brisk-walking training followed by a 12-week conventional behavioural change intervention. The primary outcome is minutes of moderate-to-vigorous physical activity (MVPA). This study aims to recruit a total of 184 participants. Generalized estimating equations (GEE) will be used to examine the effects of the intervention. ETHICS AND DISSEMINATION: The trial has been registered at ClinicalTrials.gov (Identifier: NCT05758740) on 7th March 2023, https://clinicaltrials.gov/ct2/show/NCT05758740 , and all items come from the World Health Organization Trial Registration Data Set. It has been approved by the Research Ethics Committee of Tung Wah College, Hong Kong (reference number: REC2022136). The findings will be disseminated in peer-reviewed journals and presented at international conferences relevant to the subject fields. TRIAL REGISTRATION: The trial has been registered at ClinicalTrials.gov (Identifier: NCT05758740) and all items come from the World Health Organization Trial Registration Data Set. The latest version of the protocol was published online on 7th March 2023.
Subject(s)
Frailty , Telemedicine , Humans , Aged , Sedentary Behavior , Walking , Exercise , Cognition , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: Cognitive frailty refers to the coexistence of physical frailty and cognitive impairment, and is associated with many adverse health outcomes. Although cognitive frailty is prevalent in older people, motor-cognitive training is effective at enhancing cognitive and physical function. We proposed a virtual reality (VR) simultaneous motor-cognitive training program, which allowed older people to perform daily activities in a virtual space mimicking real environments. OBJECTIVE: We aimed to (1) explore the feasibility of offering VR simultaneous motor-cognitive training to older people with cognitive frailty and (2) compare its effects with an existing motor-cognitive training program in the community on the cognitive function and physical function of older people with cognitive frailty. METHODS: A two-arm (1:1), assessor-blinded, parallel design, randomized controlled trial was employed. The eligibility criteria for participants were: (1) aged ≥60 years, (2) community dwelling, and (3) with cognitive frailty. Those in the intervention group received cognitive training (ie, cognitive games) and motor training (ie, cycling on an ergometer) simultaneously on a VR platform, mimicking the daily living activities of older people. Those in the control group received cognitive training (ie, cognitive games) on tablet computers and motor training (ie, cycling on the ergometer) sequentially on a non-VR platform. Both groups received a 30-minute session twice a week for 8 weeks. Feasibility was measured by adherence, adverse outcomes, and successful learning. The outcomes were cognitive function, physical frailty level, and walking speed. RESULTS: Seventeen participants were recruited and randomized to either the control group (n=8) or intervention group (n=9). At baseline, the median age was 74.0 years (IQR 9.5) and the median Montreal Cognitive Assessment score was 20.0 (IQR 4.0). No significant between-group differences were found in baseline characteristics except in the number of chronic illnesses (P=.04). At postintervention, the intervention group (Z=-2.67, P=.01) showed a significantly larger improvement in cognitive function than the control group (Z=-1.19, P=.24). The reduction in physical frailty in the intervention group (Z=-1.73, P=.08) was similar to that in the control group (Z=-1.89, P=.06). Improvement in walking speed based on the Timed Up-and-Go test was moderate in the intervention group (Z=-0.16, P=.11) and greater in the control group (Z=-2.52, P=.01). The recruitment rate was acceptable (17/33, 52%). Both groups had a 100% attendance rate. The intervention group had a higher completion rate than the control group. Training was terminated for one participant (1/9, 11%) due to minimal VR sickness (Virtual Reality Sickness Questionnaire score=18.3/100). Two participants (2/8, 25%) in the control group withdrew due to moderate leg pain. No injuries were observed in either group. CONCLUSIONS: This study provides preliminary evidence that the VR simultaneous motor-cognitive training is effective at enhancing the cognitive function of older people with cognitive frailty. The effect size on frailty was close to reaching a level of significance and was similar to that observed in the control group. VR training is feasible and safe for older people with cognitive frailty. TRIAL REGISTRATION: ClinicalTrials.gov NCT04467216; https://clinicaltrials.gov/ct2/show/NCT04467216.
