The Relationship Between Dual-task Gait Performance, Physical Activity Levels, Sleep and Aging in Healthy Adults

Sponsor

King's College London (Other)

Overall Status

Unknown status

CT.gov ID

NCT04144647

Collaborator

(none)

100

Enrollment

Location

Arm

21.2

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The co-ordination and control of body segments are integral in providing and maintaining postural stability. It is widely accepted that attentional demands for postural control are placed upon the individual, but these vary according to the nature of the task, the age of the individual and their postural stability. It is thought that divided attention (a technique whereby two tasks are performed at the same time whilst rapidly switching attention between the two tasks) is commonly used when multi-tasking. Divided attention may have important clinical implications to falls risk, in that older adults that experience falls have increased difficulty in switching attention between tasks such as walking and talking. Dual tasking paradigms which present postural and cognitive tasks are often used to test attentional demands for posture control and interference between the two tasks. At present it is not known what impact balance confidence, sleep, activity levels or cognitive ability impact on a person's ability to multi-task when performing complex walking tasks that reflect the complexity of mobilising in real-life situations.

Condition or Disease	Intervention/Treatment	Phase
Healthy Adults	Other: Single testing session	N/A

Detailed Description

The proposed study aims to investigate, in healthy adults aged between 18-80 years old, a) the effect of combining functional gait tasks with different types of dual-tasks and cognitive task categories on total Functional Gait Assessment (FGA) score (primary task), and task prioritisation; b) the relationship between FGA single and dual task performance, age, sleep and PA levels; c) the relationship between age, balance confidence, psychological symptoms and sleep with functional gait single and dual task performance, cognitive function, quality of life and PA levels.

Principle Research Questions:

What is the effect of dual-task type and/or cognitive task category on FGA performance (primary task), gait speed and task prioritisation?
What is the relationship between age, balance confidence, psychological symptoms, quality of life and sleep with FGA single and dual task performance, cognitive function and PA levels in healthy adults?

Hypothesis:

Cognitive dual tasks will affect performance of the primary FGA task, gait speed and task prioritisation more than an auditory dual task.
A more sedentary lifestyle, increasing age, poorer sleep state, balance confidence and/or lower (i.e. poorer performance) cognitive function test scores will affect performance on FGA dual task performance.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

100 healthy participants aged between 18-80 years old are recruited for this study. All individuals that express interest in this study, will be provided with a Participant Information Sheet (PIS) either by email or hard copy by post. All prospective subjects will be screened for matching of inclusion criteria. After a potential participant contacts the PhD student, Ms Viktoria Azoidou, regarding his/her interest in participating in the study, the person will be asked to complete the screening questionnaire via telephone or email as per each individual's preference regarding eligibility criteria. If after screening, a potential participant meets the eligibility criteria, an appointment will be arranged to discuss any concerns or answer any questions participants may have regarding the PIS, then sign the written consent form and be assessed attend the research laboratory for the single testing session.100 healthy participants aged between 18-80 years old are recruited for this study. All individuals that express interest in this study, will be provided with a Participant Information Sheet (PIS) either by email or hard copy by post. All prospective subjects will be screened for matching of inclusion criteria. After a potential participant contacts the PhD student, Ms Viktoria Azoidou, regarding his/her interest in participating in the study, the person will be asked to complete the screening questionnaire via telephone or email as per each individual's preference regarding eligibility criteria. If after screening, a potential participant meets the eligibility criteria, an appointment will be arranged to discuss any concerns or answer any questions participants may have regarding the PIS, then sign the written consent form and be assessed attend the research laboratory for the single testing session.

Masking:

None (Open Label)

Masking Description:

This is a simple case-controlled study of physiotherapy assessments. It doe snot include masking procedures.

Primary Purpose:

Screening

Official Title:

The Relationship Between Dual-task Gait Performance, Physical Activity Levels, Sleep and Aging in Healthy Adults

Actual Study Start Date :

Feb 25, 2019

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy adults 18-80 years old Healthy adults 18-80 years old	Other: Single testing session All participants that meet the inclusion criteria, will have to attend the research laboratory at Centre for Human and Applied Physiological Sciences, Shepherd's House, Guy's Campus, King's College London, SE1 1UL to be assessed in a single testing session. The testing session will require them to complete some questionnaires regarding balance confidence, psychological state, sleep and physical function and to undertake some simple tests of cognitive function. They will also undertake a brief dynamic balance assessment and the dual-task gait test. The dual-task component involves two cognitive tasks (a numeracy and a literacy task) or auditory task. The gait test will be performed separately and then together with each of two cognitive tasks or auditory task. On the day, after the testing, each participant will, also, be provided a physical activity monitor (accelerometer-AX3) to wear on their wrist for 24 hours a day, seven days a week without taking it off. Other Names: Observational

Arm

Intervention/Treatment

Experimental: Healthy adults 18-80 years old

Healthy adults 18-80 years old

Other: Single testing session

All participants that meet the inclusion criteria, will have to attend the research laboratory at Centre for Human and Applied Physiological Sciences, Shepherd's House, Guy's Campus, King's College London, SE1 1UL to be assessed in a single testing session. The testing session will require them to complete some questionnaires regarding balance confidence, psychological state, sleep and physical function and to undertake some simple tests of cognitive function. They will also undertake a brief dynamic balance assessment and the dual-task gait test. The dual-task component involves two cognitive tasks (a numeracy and a literacy task) or auditory task. The gait test will be performed separately and then together with each of two cognitive tasks or auditory task. On the day, after the testing, each participant will, also, be provided a physical activity monitor (accelerometer-AX3) to wear on their wrist for 24 hours a day, seven days a week without taking it off.

Other Names:

Observational

Outcome Measures

Primary Outcome Measures

Functional Gait Assessment [5 minutes]
The primary outcome is the Functional Gait Assessment which is a 10-item test that assesses performance on complex gait tasks (i.e. walking with head turns, stepping over an obstacle or stopping and turning). Scores range from 0 to 30. The highest score is 30 and greater outcomes are indicative of better performance while lower scores are indicative of poorer performance. The Functional Gait Assessment has been validated in healthy people, older adults with a history of falls and balance impairments, and people with a vestibular disorder. The minimal detectable change for Functional Gait Assessment is reported to be 6 points in persons with balance and vestibular disorders. Scores ≤22/30 identify fall risk and are predictable of falls in community-living older persons within 6 months.

Secondary Outcome Measures

Functional Gait Dual-Task Test [30 minutes]
The Functional Gait Assessment in isolation will always be completed first in (primary outcome measure), followed by the dual-task test conditions, which will be completed in random order. The cognitive dual-tasking condition will involve a numeracy and literacy task and the auditory stimuli will involve restaurant noise.
Mini-Balance Evaluation Systems Test [5 minutes]
The Mini-Balance Evaluation Test is a measure of dynamic balance (anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait). The Mini-Balance Evaluation Systems Test consists of 14 items, with scores ranging from 0 to 28 points. Higher scores indicate better outcome while lower scores poorer outcome. Scores ≤ 20/32 indicate increased falls risk.
Cambridge Neuropsychological Test Automated Battery [45 minutes]
Cambridge Neuropsychological Test Automated Battery is a semiautomated computer program that utilizes a touch screen technology and press pad, to assess neurocognitive function. The Cambridge Neuropsychological Test Automated Battery core cognition battery is a validated cognitive assessment system for assessing multiple components of cognitive function, including attention, visual memory, spatial memory, executive function and reaction time.
Standard pure tone audiometry [10 minutes]
Standard pure tone audiometry is considered a 'gold' standard test of audiologic examination. This test will be completed with a portable calibrated audiometer (GSI Pello Standard model with DD45's, IP30 and B81, Serial Number: GS0071085, calibrated by Guymark UK Ltd).
Speech in Babble Test [10 minutes]
The Speech in Babble Test is a low redundancy speech in babble type noise test. The Speech in Babble Test is presented on a calibrated computer using Matlab software. There are 8 in total phonemically and phonetically balanced word lists. The words are presented in the background of a 20-talker babble noise. Two randomly selected monosyllabic consonant vowel consonant word lists in a background of multitalker babble are presented to each ear (i.e. each ear is tested twice). The signal to noise ratio during the test is varied adaptively.
Axivity Wrist Band 3-Axis logging accelerometer [7 days]
Participants' physical activity level will be assessed using a wrist-worn accelerometer, the Axivity Wrist Band 3-Axis logging accelerometer. The Axivity Wrist Band 3-Axis logging accelerometer captures triaxial acceleration data at 100 Hz with a dynamic range of ±8 g and has been widely used in population-based studies to assess physical activity levels.
Activity-specific Balance Confidence Scale [3 minutes]
The Activity-specific Balance Confidence Scale is a self-perceived questionnaire with 16 items and assesses balance confidence in daily activities . Scores range from 0 to 100. Higher scores are indicative of better outcome while lower scores indicate poorer outcome. A score ≤67/100 indicate increased falls risk.
Hospital Anxiety and Depression Scale [3 minutes]
The Hospital Anxiety and Depression Scale, a 14-item scale which assesses non-somatic anxiety and depression symptoms, will also be completed. Scores range from 0 to 21 for each subscale with a score ≥8 proposed for the identification of caseness, for both depression and anxiety. Higher scores are indicative of poorer outcomes.
Pittsburgh Sleep Quality Index [3 minutes]
The Pittsburgh Sleep Quality Index generates seven component scores: subjective sleep quality, sleep latency, sleep duration habitual sleep efficiency, sleep disturbance, use of sleeping medication, and daytime dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality while lower scores indicate better outcomes. In distinguishing good and poor sleepers, a global Pittsburgh Sleep Quality Index score >5 yields a sensitivity of 89.6% and a specificity of 86.5%.
Epworth Sleepiness Scale [3 minutes]
The Epworth Sleepiness Scale is a validated and widely used questionnaire exploring daytime sleepiness. It consists of eight questions that are added together to obtain a single number. Higher scores indicate sleeping disorder while lower scores are indicative of better outcomes. Scores range from 0 to 24. The reference range of 'normal' Epworth Sleepiness Scale scores is 0-10 while Epworth Sleepiness Scale scores of 11-24 represent increasing levels of 'excessive daytime sleepiness'.
EQ-5D-5L [3 minutes]
The EQ-5D-5L is a generic measure of health status for clinical and economic appraisal. The EQ-5D-5L descriptive system comprises of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Situational Vertigo Questionnaire [3 minutes]
The Situational Vertigo Questionnaire -shortened version measures how frequently symptoms are provoked or exacerbated in environments with visual vestibular mismatch or intense visual motion (e.g. travelling on escalators, crowds, scrolling computer screens). Scores range from 0 to 4. Higher scores indicate poorer outcomes while lower scores are indicative of better outcomes. Scores ≥0.7/4 indicate visual induced dizziness symptoms.
Dizziness Handicap Inventory [3 minutes]
The Dizziness Handicap Inventory is a 25-item self-assessment inventory designed to evaluate self-perceived handicap imposed by symptoms of dizziness. It consists of three domains: emotional, functional and physical. Total scores range from 0 to 100, with higher score indicating greater perceived handicap while lower scores are indicative of better performance. Scores between 0-30, 31-60, and 61-100 on the Dizziness Handicap Inventory indicate mild, moderate, and severe perceived handicap respectively, and can differentiate a person's functional abilities.
Cognitive and Behavioural Symptom Questionnaire [3 minutes]
The Cognitive and Behavioural Symptom Questionnaire is a measure of subjects' cognitive (i.e. beliefs) and behavioural responses to symptoms of their health condition. This measure includes five cognitive (i.e. beliefs) subscales: Symptom Focusing, Catastrophizing, Damaging Beliefs, Fear Avoidance and Embarrassment Avoidance; and two behavioural subscales: All or- Nothing and Avoidance/Rest.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

community-dwelling healthy adults
aged 18-80 years old
independently mobile.

Exclusion Criteria:

Individuals have a central nervous system disorder vestibular disorder and/or acute orthopaedic/musculoskeletal disorder affecting balance control and/or gait
individuals with lack of a good grasp of written and spoken English language.