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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04692974
• Other study ID #: H-20-038
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: August 2021

Study information

• Verified date: April 2021
• Source: National University, Singapore
• Contact: Savannah Siew, BSc (Hons)
• Phone: 90697618
• Email: savannahsiew[@]nus.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Frailty
• Mild Cognitive Impairment

Intervention

Device:
• Mobile phone application and smart watch
Mobile phone application prompts

Locations

Country	Name	City	State
Singapore	Hannah Senior Activity Center	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University, Singapore	Sengkang General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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