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

Primary Purpose

Mild Cognitive Impairment, Frailty

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Mobile phone application and smart watch
Sponsored by
National University of Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Cognitive Frailty, Physical Frailty, Physical Activity, Mild Cognitive Impairment, Technology

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hannah Senior Activity CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months
Hand grip strength in kilograms
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
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
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
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
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
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
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
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

Secondary Outcome Measures

Mean Change from Baseline in Steps Taken measured by the smart watch 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
Minutes of moderate exercise in a week
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

Full Information

First Posted
December 10, 2020
Last Updated
April 14, 2021
Sponsor
National University of Singapore
Collaborators
Sengkang General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04692974
Brief Title
Cognitive Frailty in Older Adults: The Role of Technology in Physical Activity Enhancement
Official Title
Cognitive Frailty in Older Adults: Protocol of a Pilot RCT of the Role of Technology in Physical Activity Enhancement
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
Collaborators
Sengkang General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Frailty
Keywords
Cognitive Frailty, Physical Frailty, Physical Activity, Mild Cognitive Impairment, Technology

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention and control group design
Masking
InvestigatorOutcomes Assessor
Masking Description
Randomization will be carried out by a research assistant not involved in the study. The assessors will be blind to the treatment assignment of the participant when administering the questionnaires.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Mobile phone application and smart watch
Intervention Description
Mobile phone application prompts
Primary Outcome Measure Information:
Title
Mean Change from Baseline in frailty screening scores on the FRAIL questionnaire at 3 and 6 months
Description
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).
Time Frame
At 3 months and 6 months
Title
Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months
Description
Hand grip strength in kilograms
Time Frame
At 3 months and 6 months
Title
Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months
Description
Gait speed, time taken to walk a specified distance as fast as possible, in seconds
Time Frame
At 3 months and 6 months
Title
Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months
Description
Timed Up and Go (TUG), time taken to stand up from a chair, walk 3 meters, turn around and sit back down, in seconds
Time Frame
At 3 months and 6 months
Title
Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months
Description
Chair Stand Test, time taken to stand up fully 5 times from a chair in seconds
Time Frame
At 3 months and 6 months
Title
Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
Description
Rey Auditory Verbal Learning Test (RAVLT) assesses verbal learning and memory
Time Frame
At 3 months and 6 months
Title
Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
Description
Digit Span Forward and Backward (DS) assesses working memory capacity
Time Frame
At 3 months and 6 months
Title
Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
Description
Colour Trails Test (CTT) assesses visual-spatial skills and attention
Time Frame
At 3 months and 6 months
Title
Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
Description
Wechsler's Block Design (WBS) assesses visuospatial ability
Time Frame
At 3 months and 6 months
Title
Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
Description
Semantic Fluency - animals (SFA) assesses semantic memory
Time Frame
At 3 months and 6 months
Secondary Outcome Measure Information:
Title
Mean Change from Baseline in Steps Taken measured by the smart watch at 3 months and 6 months
Description
Number of steps taken daily
Time Frame
At 3 months and 6 months
Title
Mean Change from Baseline in moderate exercise measured by the smart watch at 3 months and 6 months
Description
Minutes of moderate exercise in a week
Time Frame
At 3 months and 6 months
Title
Mean Change from Baseline in levels of physical activity measured by the "International Physical Activity Questionnaire" at 3 months and 6 months
Description
Self-reported minutes and hours of vigorous or moderate exercise
Time Frame
At 3 months and 6 months
Other Pre-specified Outcome Measures:
Title
Control variable of sleep quality as measured on the Pittsburgh Sleep Quality Index (PSQI) at 3 and 6 months
Description
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.
Time Frame
At 3 months and 6 months
Title
Control variable of levels of motivation as measured on the Barriers Self-efficacy Scale at 3 and 6 months
Description
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.
Time Frame
At 3 months and 6 months
Title
Control variable of depression as measured on the Geriatric Depression Scale at 3 and 6 months
Description
Self-reported screening test for depression. Scores ranges from 0-15 and a higher score reflect more depressive symptoms.
Time Frame
At 3 months and 6 months
Title
Control variable of anxiety as measured on the Geriatric Anxiety Inventory at 3 and 6 months
Description
Self-reported screening test for anxiety. Scores ranges from 0-20 and a higher score reflect more anxiety symptoms.
Time Frame
At 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Savannah Siew, BSc (Hons)
Phone
90697618
Email
savannahsiew@nus.edu.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Rathi Mahendran, MMed (Psych)
Email
pcmrathi@nus.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rathi Mahendran, MMed (Psych)
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hannah Senior Activity Center
City
Singapore
ZIP/Postal Code
590021
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Savannah Siew, BSc (Hons)
Phone
90697618
Email
savannahsiew@nus.edu.sg
First Name & Middle Initial & Last Name & Degree
Rathi Mahendran, MMed (Psych)
First Name & Middle Initial & Last Name & Degree
Iris Rawtaer, MMed (Psych)
First Name & Middle Initial & Last Name & Degree
Junhong Yu, PhD
First Name & Middle Initial & Last Name & Degree
Savannah Siew, BSc (Hons)

12. IPD Sharing Statement

Plan to Share IPD
No

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

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