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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Frailty; Mild Cognitive Impairment
• Intervention / Treatment: Device: Mobile phone application and smart watch

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Savannah Siew, BSc (Hons); Phone Number: 90697618; Email: savannahsiew@nus.edu.sg
• Study Contact Backup: Name: Rathi Mahendran, MMed (Psych); Email: pcmrathi@nus.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore, 590021
    • Recruiting
    • Hannah Senior Activity Center
    • Contact: Savannah Siew, BSc (Hons); Phone Number: 90697618; Email: savannahsiew@nus.edu.sg
    • Principal Investigator: Rathi Mahendran, MMed (Psych)
    • Sub-Investigator: Iris Rawtaer, MMed (Psych)
    • Sub-Investigator: Junhong Yu, PhD
    • Sub-Investigator: Savannah Siew, BSc (Hons)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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; Mobile phone application prompts
No Intervention: Control Group; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Control variable of sleep quality as measured on the Pittsburgh Sleep Quality Index (PSQI) at 3 and 6 months	Self-reported questionnaire on sleep quality in the last month. Global score ranges from 0-21 with a score of 5 and above indicating poor sleep quality. The higher the score, the poorer the sleep quality.	At 3 months and 6 months
Control variable of levels of motivation as measured on the Barriers Self-efficacy Scale at 3 and 6 months	Self-reported questionnaire on levels of motivation specific to exercising. Scores ranges from 0-100. The higher the score, the higher the level of self-efficacy.	At 3 months and 6 months
Control variable of depression as measured on the Geriatric Depression Scale at 3 and 6 months	Self-reported screening test for depression. Scores ranges from 0-15 and a higher score reflect more depressive symptoms.	At 3 months and 6 months
Control variable of anxiety as measured on the Geriatric Anxiety Inventory at 3 and 6 months	Self-reported screening test for anxiety. Scores ranges from 0-20 and a higher score reflect more anxiety symptoms.	At 3 months and 6 months

Collaborators and Investigators

• Sponsor: National University of Singapore
• Collaborators: Sengkang General Hospital
• Investigators: Principal Investigator: Rathi Mahendran, MMed (Psych), National University of Singapore

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Physical Activity; Mild Cognitive Impairment; Technology; Cognitive Frailty; Physical Frailty
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Frailty
• Other Study ID Numbers: H-20-038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No