Clinical trial NCT05950269: Walking Aid and Locomotion Knowledge in Emergency Rooms (WALKER 1) for Elderly People
Official title: Walking Aid and Locomotion Knowledge in Emergency Rooms (WALKER 1): Training and Provision of Walking Aids to Promote Autonomy and Mobility of Elderly People in Emergency Care - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobility Limitation
Keywords: Geriatric
Life space
Walking aids
Emergency room
Clinical Trial
Mobility
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 153
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Older adults have higher rates of emergency department admissions when compared to their younger counterparts. Mobility is the ability to move around but also encompasses the environment and the ability to adapt to it. Walking aids can be used to improve mobility and prevent falls. According to international guidelines, they must be available in Geriatric Emergency Department. This study aims to evaluate the effectiveness of a program of training and provision of walking aids (WA), associated or not with telemonitoring, on mobility, quality of life, fear of falling, and risk of falls up to 3 months in older adults cared for in an emergency department.

Detailed description: A randomized clinical trial will be carried out in the emergency department of Hospital Sírio-Libanês. Participants will be randomized and allocated into three intervention groups, as follows: A) Walking aid group; B) Walking aid and telemonitoring group; C) Control group. Patients will undergo a baseline evaluation encompassing sociodemographic and clinical data, mobility in life spaces (Life Space Assessment), gait speed, muscle strength, functionality (Barthel Index, Katz index, and Lawton-Brody Scale), quality of life (Euro Quality of Life Instrument-5D), fear of falling (Falls Efficacy Scale International), history of falls, cognition (10-Point Cognitive Screener) and mood (15-point Geriatric Depression Scale) before the intervention. Gait time and fear of falling will be assessed again after the intervention. Finally, mobility in life spaces, functionality, quality of life, fear of falling, history of falls, cognition, and mood will be assessed 3 months after discharge from the geriatric emergency department through a telephone interview.

Eligibility criteria: Inclusion Criteria:

* 65 years or older
* Admitted to the Geriatric Emergency Department of Hospital Sírio-Libanês
* Willing and able to give informed consent
* Least one of the following for indication and training of mobility aids: reduction of postural instability; improvement of motor control; increase of somatosensory feedback; reduction of biomechanical overload; safe promotion of autonomy; fall history (in the last six months).

Exclusion Criteria:

* Altered level of conscience
* need for supplemental oxygen (≥3L/min)
* respiratory distress
* hemodynamic instability
* postural instability with a tendency to fall backward
* cognitive impairment that limits the use of walking aids
* hospitalization after Emergency Department evaluation
* Delirium

Primary outcomes:
measure: Life-Space Assessment (LSA)
timeFrame: At baseline and after completion of the 3 and 6 months intervention to assess change
measure: Falls Efficacy Scale International (FES-I)
timeFrame: At baseline, immediately after the intervention and after completion of the 3 and 6 months intervention to assess change
Secondary outcomes:
measure: Timed Up and Go test (TUG)
timeFrame: At baseline and immediately after the intervention
measure: One-minute sit-to-stand test
timeFrame: At baseline and after completion of the 3 and 6 months intervention to assess change
measure: Katz index
timeFrame: At baseline and after completion of the 3 and 6 months intervention to assess change
measure: Barthel index
timeFrame: At baseline and after completion of the 3 and 6 months intervention to assess change
measure: Lawton-Brody scale
timeFrame: At baseline and after completion of the 3 and 6 months intervention to assess change
measure: Euro Quality of Life Instrument-5D (EQ-5D)
timeFrame: At baseline and after completion of the 3 and 6 months intervention to assess change
measure: Geriatric Depression Scale (GDS-15)
timeFrame: At baseline and after completion of the 3 and 6 months intervention to assess change
measure: 10-Point Cognitive Screener (10-CS)
timeFrame: At baseline and after completion of the 3 and 6 months intervention to assess change
measure: Fall History
timeFrame: At baseline and after completion of the 3 and 6 months intervention to assess change
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Sírio Libanês
Study officials:
References:
citation: Kennedy RE, Williams CP, Sawyer P, Lo AX, Connelly K, Nassel A, Brown CJ. Life-Space Predicts Health Care Utilization in Community-Dwelling Older Adults. J Aging Health. 2019 Feb;31(2):280-292. doi: 10.1177/0898264317730487. Epub 2017 Sep 14.
citation: Shimada H, Sawyer P, Harada K, Kaneya S, Nihei K, Asakawa Y, Yoshii C, Hagiwara A, Furuna T, Ishizaki T. Predictive validity of the classification schema for functional mobility tests in instrumental activities of daily living decline among older adults. Arch Phys Med Rehabil. 2010 Feb;91(2):241-6. doi: 10.1016/j.apmr.2009.10.027.
citation: Brown CJ, Kennedy RE, Lo AX, Williams CP, Sawyer P. Impact of Emergency Department Visits and Hospitalization on Mobility Among Community-Dwelling Older Adults. Am J Med. 2016 Oct;129(10):1124.e9-1124.e15. doi: 10.1016/j.amjmed.2016.05.016. Epub 2016 Jun 8.
citation: van den Berg N, Schumann M, Kraft K, Hoffmann W. Telemedicine and telecare for older patients--a systematic review. Maturitas. 2012 Oct;73(2):94-114. doi: 10.1016/j.maturitas.2012.06.010. Epub 2012 Jul 17.
citation: Bateni H, Maki BE. Assistive devices for balance and mobility: benefits, demands, and adverse consequences. Arch Phys Med Rehabil. 2005 Jan;86(1):134-45. doi: 10.1016/j.apmr.2004.04.023.