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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04692974
Enrollment
60
Registered
2021-01-05
Start date
2020-12-15
Completion date
2021-08-31
Last updated
2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Mild Cognitive Impairment

Keywords

Cognitive Frailty, Physical Frailty, Physical Activity, Mild Cognitive Impairment, Technology

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.

Interventions

DEVICEMobile phone application and smart watch

Mobile phone application prompts

Sponsors

Sengkang General Hospital
CollaboratorOTHER
National University of Singapore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes 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.

Intervention model description

Intervention and control group design

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Change from Baseline in frailty screening scores on the FRAIL questionnaire at 3 and 6 monthsAt 3 months and 6 months5 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 cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 monthsAt 3 months and 6 monthsRey Auditory Verbal Learning Test (RAVLT) assesses verbal learning and memory
Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 monthsAt 3 months and 6 monthsHand grip strength in kilograms

Secondary

MeasureTime frameDescription
Mean Change from Baseline in moderate exercise measured by the smart watch at 3 months and 6 monthsAt 3 months and 6 monthsMinutes of moderate exercise in a week
Mean Change from Baseline in Steps Taken measured by the smart watch at 3 months and 6 monthsAt 3 months and 6 monthsNumber of steps taken daily
Mean Change from Baseline in levels of physical activity measured by the International Physical Activity Questionnaire at 3 months and 6 monthsAt 3 months and 6 monthsSelf-reported minutes and hours of vigorous or moderate exercise

Other

MeasureTime frameDescription
Control variable of levels of motivation as measured on the Barriers Self-efficacy Scale at 3 and 6 monthsAt 3 months and 6 monthsSelf-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.
Control variable of anxiety as measured on the Geriatric Anxiety Inventory at 3 and 6 monthsAt 3 months and 6 monthsSelf-reported screening test for anxiety. Scores ranges from 0-20 and a higher score reflect more anxiety symptoms.
Control variable of depression as measured on the Geriatric Depression Scale at 3 and 6 monthsAt 3 months and 6 monthsSelf-reported screening test for depression. Scores ranges from 0-15 and a higher score reflect more depressive symptoms.
Control variable of sleep quality as measured on the Pittsburgh Sleep Quality Index (PSQI) at 3 and 6 monthsAt 3 months and 6 monthsSelf-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.

Countries

Singapore

Contacts

Primary ContactSavannah Siew, BSc (Hons)
savannahsiew@nus.edu.sg90697618
Backup ContactRathi Mahendran, MMed (Psych)
pcmrathi@nus.edu.sg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026