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

NCT04692974 | Unknown

• 1 other identifier: H-20-038
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Frailty

Keywords

Cognitive Frailty; Physical Frailty; Physical Activity; Mild Cognitive Impairment; Technology

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (3)

• Mean Change from Baseline in Steps Taken measured by the smart watch at 3 months and 6 months

  At 3 months and 6 months

• Mean Change from Baseline in moderate exercise measured by the smart watch at 3 months and 6 months

  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

  At 3 months and 6 months

Other Outcomes (4)

• Control variable of sleep quality as measured on the Pittsburgh Sleep Quality Index (PSQI) at 3 and 6 months

  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

  At 3 months and 6 months

• Control variable of depression as measured on the Geriatric Depression Scale at 3 and 6 months

  At 3 months and 6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Mobile phone application and smart watch DEVICE

Mobile phone application prompts

Intervention Group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older adults aged 60 to 85 years

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Singapore: lead
• Sengkang General Hospital: collaborator

Study Sites (1)

Hannah Senior Activity Center

Singapore, 590021, Singapore

RECRUITING

Related Publications (1)

• Kiah Hui Siew S, Yu J, Teo TL, Chua KC, Mahendran R, Rawtaer I. Technology and physical activity for preventing cognitive and physical decline in older adults: Protocol of a pilot RCT. PLoS One. 2024 Feb 23;19(2):e0293340. doi: 10.1371/journal.pone.0293340. eCollection 2024.

  PMID: 38394113 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Rathi Mahendran, MMed (Psych)

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Savannah Siew, BSc (Hons)

CONTACT

90697618; savannahsiew@nus.edu.sg

Rathi Mahendran, MMed (Psych)

CONTACT

pcmrathi@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Senior Consultant Psychiatrist, Principal Investigator

Model Details: Intervention and control group design

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: January 5, 2021
• Study Start: December 15, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)