Clinical trial NCT04692974: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Frailty
Keywords: Cognitive Frailty
Physical Frailty
Physical Activity
Mild Cognitive Impairment
Technology
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Sengkang General Hospital
First posted: 2021-01-05
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention and control group design
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Mean Change from Baseline in frailty screening scores on the FRAIL questionnaire at 3 and 6 months
timeFrame: At 3 months and 6 months
measure: Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months
timeFrame: At 3 months and 6 months
measure: Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months
timeFrame: At 3 months and 6 months
measure: Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months
timeFrame: At 3 months and 6 months
measure: Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months
timeFrame: At 3 months and 6 months
measure: Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
timeFrame: At 3 months and 6 months
measure: Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
timeFrame: At 3 months and 6 months
measure: Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
timeFrame: At 3 months and 6 months
measure: Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
timeFrame: At 3 months and 6 months
measure: Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months
timeFrame: At 3 months and 6 months
Secondary outcomes:
measure: Mean Change from Baseline in Steps Taken measured by the smart watch at 3 months and 6 months
timeFrame: At 3 months and 6 months
measure: Mean Change from Baseline in moderate exercise measured by the smart watch at 3 months and 6 months
timeFrame: At 3 months and 6 months
measure: Mean Change from Baseline in levels of physical activity measured by the "International Physical Activity Questionnaire" at 3 months and 6 months
timeFrame: At 3 months and 6 months
Other outcomes:
measure: Control variable of sleep quality as measured on the Pittsburgh Sleep Quality Index (PSQI) at 3 and 6 months
timeFrame: At 3 months and 6 months
measure: Control variable of levels of motivation as measured on the Barriers Self-efficacy Scale at 3 and 6 months
timeFrame: At 3 months and 6 months
measure: Control variable of depression as measured on the Geriatric Depression Scale at 3 and 6 months
timeFrame: At 3 months and 6 months
measure: Control variable of anxiety as measured on the Geriatric Anxiety Inventory at 3 and 6 months
timeFrame: At 3 months and 6 months
Locations:
city: Singapore
country: Singapore
facility: Hannah Senior Activity Center
Study officials:
affiliation: National University of Singapore
name: Rathi Mahendran, MMed (Psych)
role: PRINCIPAL_INVESTIGATOR
References: