Cognitive Frailty in Older Adults: The Role of Technology in Physical Activity Enhancement

Study Overview
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Brief Summary
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This study intends to determine if smart watches and mobile phone application prompts can complement physical activity as a preventive intervention by motivating participants to exercise, so as to improve their physical and cognitive outcomes. The investigators hypothesize that technology will help increase engagement in physical activity for the intervention group relative to the control group and subsequently improve cognitive and physical outcomes.

Detailed Description
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This study aims to explore the role of technology -- in the form of smart watches and mobile phone application -- in physical activity enhancement on cognitive frailty outcomes. Cognitive frailty is defined here as having both physical frailty and cognitive impairment but does not satisfy criteria for Major Neurocognitive Disorder. The investigators postulate that for older adults, such technology will help increase engagement in physical activity with subsequent improvement in cognitive and physical outcomes at follow up. This is with the aim of preventing this particular group from deteriorating to cognitive frailty because of the accompanying increased risk for adverse outcomes and morbidity. This pilot study will be a randomized control trial with 2 treatment arms. Assessments will be done prior to and following the intervention period. During the period of intervention, the wearable will act as a tracking device and will be paired with a mobile application to issue prompts to the participant when necessary. The independent variable explored in the study is the use of the wearable while the levels of physical and cognitive improvements are the dependent measures. These will be tracked at baseline, 3 months and 6 months. Additionally, the mediating variable measured is the levels of physical activity to ensure that the proposed outcomes are affected through an increased level of physical activity encouraged by the use of the device. If innovations like technology and the role of self-management proves efficacious, the future of healthcare in the context of a rapidly aging population will be more sustainable. Furthermore, this supporting role of technology in positive behavioral modification amongst older adults can have a multitude of applications in subsequent healthcare interventions.

Official Title
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Cognitive Frailty in Older Adults: Protocol of a Pilot RCT of the Role of Technology in Physical Activity Enhancement

Conditions
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Frailty, Mild Cognitive Impairment

Intervention / Treatment
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* Device: Mobile phone application and smart watch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older adults aged 60 to 85 years Exclusion Criteria: Engages in vigorous exercises as determined by having more than 0 minutes of vigorous exercise on the International Physical Activity Questionnaire (IPAQ). Has medical contraindications for exercising, including but not limited to: physical disabilities or heart conditions where the primary doctor disallows exercising at moderate intensity. Does not own an Android phone which can support at least a version 6.0 Operating System

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention and control group design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Participants in the intervention group will be given the wearables which they will use together with the accompanying mobile application for the period of the study (6 months). During the period of intervention, the wearable will track the physical activity of the older adults via the number of steps taken and number of hours of moderate physical work (based on heart rate). Heart rate and steps will be tracked whenever participants are wearing the watch, which is when they are awake. The watch is to be charged every night when they are sleeping. Participants will have to log down their physical activity by activating the physical activity tracker either on the watch or on the mobile application. If they did not hit the required level of physical activity, they will be sent a notification prompt through the mobile application with details of nearby workout locations as recommendation. | Device: Mobile phone application and smart watch<br>* Mobile phone application prompts<br>|
| No Intervention: Control Group<br>For the control group, they will wear the wearables as a tracking device for the period of the study (6 months). No prompts will be given and the mobile application will only be installed but not used for this group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change from Baseline in frailty screening scores on the FRAIL questionnaire at 3 and 6 months | 5 questions on fatigue, resistance, ambulation, illness and loss of weight. It is a simple screening test for frailty. Scores of 0 (non-frail), 1-2 (pre-frail) and 3-5 (frail). | At 3 months and 6 months | 
| Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months | Hand grip strength in kilograms | At 3 months and 6 months | 
| Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months | Gait speed, time taken to walk a specified distance as fast as possible, in seconds | At 3 months and 6 months | 
| Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months | Timed Up and Go (TUG), time taken to stand up from a chair, walk 3 meters, turn around and sit back down, in seconds | At 3 months and 6 months | 
| Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months | Chair Stand Test, time taken to stand up fully 5 times from a chair in seconds | At 3 months and 6 months | 
| Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months | Rey Auditory Verbal Learning Test (RAVLT) assesses verbal learning and memory | At 3 months and 6 months | 
| Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months | Digit Span Forward and Backward (DS) assesses working memory capacity | At 3 months and 6 months | 
| Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months | Colour Trails Test (CTT) assesses visual-spatial skills and attention | At 3 months and 6 months | 
| Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months | Wechsler's Block Design (WBS) assesses visuospatial ability | At 3 months and 6 months | 
| Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months | Semantic Fluency - animals (SFA) assesses semantic memory | At 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change from Baseline in Steps Taken measured by the smart watch at 3 months and 6 months | Number of steps taken daily | At 3 months and 6 months | 
| Mean Change from Baseline in moderate exercise measured by the smart watch at 3 months and 6 months | Minutes of moderate exercise in a week | At 3 months and 6 months | 
| Mean Change from Baseline in levels of physical activity measured by the International Physical Activity Questionnaire at 3 months and 6 months | Self-reported minutes and hours of vigorous or moderate exercise | At 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Frailty, Physical Frailty, Physical Activity, Mild Cognitive Impairment, Technology