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

Not Applicable

• Conditions: Frailty; Mild Cognitive Impairment
• Interventions: Device: Mobile phone application and smart watch

• Registration Number: NCT04692974
• Lead Sponsor: National University of Singapore

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-12-10
• Study Start: 2020-12-15
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2021-01-05
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-19
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Mobile phone application and smart watch	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.

Primary Outcome Measures

Name	Time	Method
Mean Change from Baseline in frailty screening scores on the FRAIL questionnaire at 3 and 6 months	At 3 months 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).
Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months	At 3 months and 6 months	Chair Stand Test, time taken to stand up fully 5 times from a chair in seconds
Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months	At 3 months and 6 months	Semantic Fluency - animals (SFA) assesses semantic memory

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hannah Senior Activity Center; 🇸🇬 Singapore, Singapore