Clinical trial NCT02570178: Effectiveness of an Intervention to Improve Balance and Decrease Falls in the Elderly (EWii)
Official title: Randomized Clinical Trial Evaluating the Effectiveness of a Primary Care Intervention Using the NintendoTM Wii Console to Improve Balance and Decrease Falls in the Elderly (EWii)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Balance
Accidental Falls
Intervention Studies
Keywords: clinical trial
accidental falls
postural balance
elderly
primary Health Care
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 1037
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objectives of this study are to evaluate the usefulness of an intervention utilizing the NintendoTM Wii console in order to improve balance, thereby decreasing both the fear of falling as well as the number of falls, and to evaluate the correlation between balance as determined by the console and the value obtained in the Tinetti tests and the one foot stationary test.

Detailed description: Balance alteration is a risk factor for falls in elderly individuals that has physical, psychological and economic consequences. The objectives of this study are to evaluate the usefulness of an intervention utilizing the NintendoTM Wii console in order to improve balance, thereby decreasing both the fear of falling as well as the number of falls, and to evaluate the correlation between balance as determined by the console and the value obtained in the Tinetti tests and the one foot stationary test.

Methods/Design: This is a controlled, randomized clinical trial of individual assignment, carried out on patients over 70 years in age, from five primary care centers in the city of Mataró (Barcelona). 380 patients were necessary for the intervention group that carried out the balance board exercises in 2 sessions per week for a 3 month period, and 380 patients in the control group who carried out their usual habits. Balance was evaluated using the Tinetti test, the one foot stationary test and with the console, at the start of the study, at the end of the intervention (3 months) and one year later. Quarterly telephone follow-up was also conducted to keep track of falls and their consequences.

Discussion: The study aimed to connect the community with a technology that may be an easy and fun way to assist the elderly in improving their balance without the need to leave home or join rehabilitation groups, offering greater comfort for this population and decreasing healthcare costs since there is no need for specialized personnel.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 70 or older, of both genders,
* with the ability to walk, with or without technical assistance
* who are available for a one year period and who agree to participate in the study, signing an informed consent form

Exclusion Criteria:

* Home-bound patients
* individuals who are already receiving rehabilitation treatment on walking
* those with moderate cognitive deterioration (Pfeiffer ≥5)
* terminally ill patients
* individuals who do not have a telephone
* those with communication difficulties: cognitive and/or sensory deterioration, language barriers

Primary outcomes:
measure: Balance calculated by the Tinetti test
timeFrame: change from baseline in Tinetti Test at 3 and 12 months
measure: Balance calculated by the one footed stationary test
timeFrame: change from baseline in one footed stationary test at 3 and 12 months
measure: Percentage of balance calculated by the NintendoTM Wii console
timeFrame: change from baseline in Percentage of balance calculated by the NintendoTM Wii console at 3 and 12 months
measure: Fear of falling
timeFrame: change from baseline in FES-I at 3 and 12 months
Secondary outcomes:
measure: Number of falls
timeFrame: Change from baseline in number of falls at 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Jordi Gol Gurina Foundation
state: Catalonia
Study officials:
affiliation: Catalan Health System
name: Pilar Montero, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.
citation: Williams MA, Soiza RL, Jenkinson AM, Stewart A. EXercising with Computers in Later Life (EXCELL) - pilot and feasibility study of the acceptability of the Nintendo(R) WiiFit in community-dwelling fallers. BMC Res Notes. 2010 Sep 13;3:238. doi: 10.1186/1756-0500-3-238.
citation: Lister C, West JH, Cannon B, Sax T, Brodegard D. Just a fad? Gamification in health and fitness apps. JMIR Serious Games. 2014 Aug 4;2(2):e9. doi: 10.2196/games.3413.
citation: Montero-Alia P, Miralles-Basseda R, Lopez-Jimenez T, Munoz-Ortiz L, Jimenez-Gonzalez M, Prat-Rovira J, Albarran-Sanchez JL, Manresa-Dominguez JM, Andreu-Concha CM, Rodriguez-Perez MC, Marti-Cervantes JJ, Sanudo-Blanco L, Sanchez-Perez CA, Dolader-Olive S, Toran-Monserrat P. Controlled trial of balance training using a video game console in community-dwelling older adults. Age Ageing. 2019 Jul 1;48(4):506-512. doi: 10.1093/ageing/afz047.
citation: Montero-Alia P, Munoz-Ortiz L, Jimenez-Gonzalez M, Benedicto-Panell C, Altimir-Losada S, Lopez-Colomer Y, Prat-Rovira J, Amargant-Rubio JF, Jastes SM, Moreno-Buitrago A, Rodriguez-Perez MC, Teixido-Vargas C, Albarran-Sanchez JL, Candel-Gil A, Serra-Serra D, Marti-Cervantes JJ, Sanchez-Perez CA, Sanudo-Blanco L, Dolader-Olive S, Toran-Monserrat P. Study protocol of a randomized clinical trial evaluating the effectiveness of a primary care intervention using the Nintendo Wii console to improve balance and decrease falls in the elderly. BMC Geriatr. 2016 Jan 12;16:8. doi: 10.1186/s12877-015-0178-x.