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

NCT ID: NCT04144647

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-25

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

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:

1. Cognitive dual tasks will affect performance of the primary FGA task, gait speed and task prioritisation more than an auditory dual task.
2. 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Adults

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy adults 18-80 years old

Healthy adults 18-80 years old

Group Type EXPERIMENTAL

Single testing session

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Observational

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King's College London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Viktoria Azoidou

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre for Human and Applied Physiological Sciences, King's College London

London, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Reza Razavi

Role: CONTACT

02078483224

Marousa Pavlou

Role: CONTACT

02078486328

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Viktoria Azoidou

Role: primary

07751717195

Marousa Pavlou

Role: backup

02078486328

References

Explore related publications, articles, or registry entries linked to this study.

Lacour M, Bernard-Demanze L, Dumitrescu M. Posture control, aging, and attention resources: models and posture-analysis methods. Neurophysiol Clin. 2008 Dec;38(6):411-21. doi: 10.1016/j.neucli.2008.09.005. Epub 2008 Oct 9.

Reference Type RESULT
PMID: 19026961 (View on PubMed)

Woollacott M, Shumway-Cook A. Attention and the control of posture and gait: a review of an emerging area of research. Gait Posture. 2002 Aug;16(1):1-14. doi: 10.1016/s0966-6362(01)00156-4.

Reference Type RESULT
PMID: 12127181 (View on PubMed)

Yogev-Seligmann G, Hausdorff JM, Giladi N. The role of executive function and attention in gait. Mov Disord. 2008 Feb 15;23(3):329-42; quiz 472. doi: 10.1002/mds.21720.

Reference Type RESULT
PMID: 18058946 (View on PubMed)

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

Reference Type RESULT
PMID: 6880820 (View on PubMed)

Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.

Reference Type RESULT
PMID: 11832252 (View on PubMed)

Wrisley DM, Marchetti GF, Kuharsky DK, Whitney SL. Reliability, internal consistency, and validity of data obtained with the functional gait assessment. Phys Ther. 2004 Oct;84(10):906-18.

Reference Type RESULT
PMID: 15449976 (View on PubMed)

Marchetti GF, Lin CC, Alghadir A, Whitney SL. Responsiveness and minimal detectable change of the dynamic gait index and functional gait index in persons with balance and vestibular disorders. J Neurol Phys Ther. 2014 Apr;38(2):119-24. doi: 10.1097/NPT.0000000000000015.

Reference Type RESULT
PMID: 24637931 (View on PubMed)

Wrisley DM, Kumar NA. Functional gait assessment: concurrent, discriminative, and predictive validity in community-dwelling older adults. Phys Ther. 2010 May;90(5):761-73. doi: 10.2522/ptj.20090069. Epub 2010 Apr 1.

Reference Type RESULT
PMID: 20360052 (View on PubMed)

Godi M, Franchignoni F, Caligari M, Giordano A, Turcato AM, Nardone A. Comparison of reliability, validity, and responsiveness of the mini-BESTest and Berg Balance Scale in patients with balance disorders. Phys Ther. 2013 Feb;93(2):158-67. doi: 10.2522/ptj.20120171. Epub 2012 Sep 27.

Reference Type RESULT
PMID: 23023812 (View on PubMed)

Leddy AL, Crowner BE, Earhart GM. Utility of the Mini-BESTest, BESTest, and BESTest sections for balance assessments in individuals with Parkinson disease. J Neurol Phys Ther. 2011 Jun;35(2):90-7. doi: 10.1097/NPT.0b013e31821a620c.

Reference Type RESULT
PMID: 21934364 (View on PubMed)

King L, Horak F. On the mini-BESTest: scoring and the reporting of total scores. Phys Ther. 2013 Apr;93(4):571-5. doi: 10.2522/ptj.2013.93.4.571. No abstract available.

Reference Type RESULT
PMID: 23547173 (View on PubMed)

Cambridge-Cognition-Limited. CANTABeclipseâ„¢: Test Administration Guide Manual. 3rd ed. Cambridge 2015.

Reference Type RESULT

Egerhazi A, Berecz R, Bartok E, Degrell I. Automated Neuropsychological Test Battery (CANTAB) in mild cognitive impairment and in Alzheimer's disease. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Apr 13;31(3):746-51. doi: 10.1016/j.pnpbp.2007.01.011. Epub 2007 Jan 16.

Reference Type RESULT
PMID: 17289240 (View on PubMed)

Fowler KS, Saling MM, Conway EL, Semple JM, Louis WJ. Paired associate performance in the early detection of DAT. J Int Neuropsychol Soc. 2002 Jan;8(1):58-71.

Reference Type RESULT
PMID: 11843075 (View on PubMed)

Bamiou DE, Iliadou VV, Zanchetta S, Spyridakou C. What Can We Learn about Auditory Processing from Adult Hearing Questionnaires? J Am Acad Audiol. 2015 Nov-Dec;26(10):824-37. doi: 10.3766/jaaa.15009.

Reference Type RESULT
PMID: 26554488 (View on PubMed)

British Society of Audiology. Standard pure tone audiometry. British Society of Audiology-BSA 2017.

Reference Type RESULT

British Society of Audiology. Standard pure tone audiometry. British Society of Audiology-BSA 2011.

Reference Type RESULT

Doherty A, Jackson D, Hammerla N, Plotz T, Olivier P, Granat MH, White T, van Hees VT, Trenell MI, Owen CG, Preece SJ, Gillions R, Sheard S, Peakman T, Brage S, Wareham NJ. Large Scale Population Assessment of Physical Activity Using Wrist Worn Accelerometers: The UK Biobank Study. PLoS One. 2017 Feb 1;12(2):e0169649. doi: 10.1371/journal.pone.0169649. eCollection 2017.

Reference Type RESULT
PMID: 28146576 (View on PubMed)

Lee IM, Shiroma EJ. Using accelerometers to measure physical activity in large-scale epidemiological studies: issues and challenges. Br J Sports Med. 2014 Feb;48(3):197-201. doi: 10.1136/bjsports-2013-093154. Epub 2013 Dec 2.

Reference Type RESULT
PMID: 24297837 (View on PubMed)

Clarke CL, Taylor J, Crighton LJ, Goodbrand JA, McMurdo MET, Witham MD. Validation of the AX3 triaxial accelerometer in older functionally impaired people. Aging Clin Exp Res. 2017 Jun;29(3):451-457. doi: 10.1007/s40520-016-0604-8. Epub 2016 Jul 19.

Reference Type RESULT
PMID: 27435918 (View on PubMed)

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

Reference Type RESULT
PMID: 2748771 (View on PubMed)

Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.

Reference Type RESULT
PMID: 1798888 (View on PubMed)

Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

Reference Type RESULT
PMID: 21479777 (View on PubMed)

Guerraz M, Yardley L, Bertholon P, Pollak L, Rudge P, Gresty MA, Bronstein AM. Visual vertigo: symptom assessment, spatial orientation and postural control. Brain. 2001 Aug;124(Pt 8):1646-56. doi: 10.1093/brain/124.8.1646.

Reference Type RESULT
PMID: 11459755 (View on PubMed)

Bisdorff A, Von Brevern M, Lempert T, Newman-Toker DE. Classification of vestibular symptoms: towards an international classification of vestibular disorders. J Vestib Res. 2009;19(1-2):1-13. doi: 10.3233/VES-2009-0343. No abstract available.

Reference Type RESULT
PMID: 19893191 (View on PubMed)

Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. doi: 10.1001/archotol.1990.01870040046011.

Reference Type RESULT
PMID: 2317323 (View on PubMed)

Whitney SL, Wrisley DM, Brown KE, Furman JM. Is perception of handicap related to functional performance in persons with vestibular dysfunction? Otol Neurotol. 2004 Mar;25(2):139-43. doi: 10.1097/00129492-200403000-00010.

Reference Type RESULT
PMID: 15021773 (View on PubMed)

Skerrett TN, Moss-Morris R. Fatigue and social impairment in multiple sclerosis: the role of patients' cognitive and behavioral responses to their symptoms. J Psychosom Res. 2006 Nov;61(5):587-93. doi: 10.1016/j.jpsychores.2006.04.018.

Reference Type RESULT
PMID: 17084135 (View on PubMed)

Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.

Reference Type RESULT
PMID: 7814786 (View on PubMed)

Lajoie Y, Gallagher SP. Predicting falls within the elderly community: comparison of postural sway, reaction time, the Berg balance scale and the Activities-specific Balance Confidence (ABC) scale for comparing fallers and non-fallers. Arch Gerontol Geriatr. 2004 Jan-Feb;38(1):11-26. doi: 10.1016/s0167-4943(03)00082-7.

Reference Type RESULT
PMID: 14599700 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LRS-18/19-8994

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Training Improves Balance Control
NCT01547988 COMPLETED NA
Real-life Dual-Task Training
NCT06479694 RECRUITING NA