Effectiveness of an Intervention to Improve Balance and Decrease Falls in the Elderly (EWii)

NCT02570178 | Completed DMC

• 1 other identifier: PI12/01677
• Study Type: interventional
• Target: 1,037
• Locations: 1 country
• Sites: 1

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.

Conditions

Postural Balance; Accidental Falls; Intervention Studies

Keywords

clinical trial; accidental falls; postural balance; elderly; primary Health Care

Outcome Measures

Primary Outcomes (4)

• Balance calculated by the Tinetti test

  change from baseline in Tinetti Test at 3 and 12 months

• Balance calculated by the one footed stationary test

  change from baseline in one footed stationary test at 3 and 12 months

• Percentage of balance calculated by the NintendoTM Wii console

  change from baseline in Percentage of balance calculated by the NintendoTM Wii console at 3 and 12 months

• Fear of falling

  The Short FES-I (Falls Efficacy Scale) looks at the probability of falling in seven everyday situations. Scoring ranges from 7 to 28 points (high scores indicate a greater fear of falling)

  change from baseline in FES-I at 3 and 12 months

Secondary Outcomes (1)

• Number of falls

  Change from baseline in number of falls at 12 months

Study Arms (2)

standard practice advice

NO INTERVENTION

standard practice advice

balance training

OTHER

balance training using the Nintendo™ Wii console and its balance board.

Other: balance training

Interventions

balance training OTHER

Participants complete 2 sessions per week for 30 minutes each, over a period of three months and are distributed in groups of four individuals carrying out the exercises at once.The groups were led by monitors who had received standardized training. Each participant was barefoot on the balance board, carrying out the different exercises in the balance area of the Wii Fit™ game, according to the indications made on the screen.Eight out of the nine balance exercises were used from the Wii Fit™ game (balance bubble, soccer heading, ski jump, table tilt, ski slalom, penguin slide, snowboard slalom, tightrope walk);.The number of repetitions of each exercise varied depending on the skill of the participants but the total time dedicated to each exercise was the same for all group participants.

balance training

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (1)

Jordi Gol Gurina Foundation

Barcelona, Catalonia, 08007, Spain

Location

Related Publications (5)

• 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.

  PMID: 22972103 BACKGROUND

• 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.

  PMID: 20831836 BACKGROUND

• 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.

  PMID: 25654660 BACKGROUND

• 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.

  PMID: 31081504 DERIVED

• 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.

  PMID: 26796956 DERIVED

Related Links

• Percentage of balance calculated by the NintendoTM Wii console: Conducting the lame duck test which calculated how the center of gravity moves when the individual is on one foot for a maximum of thirty seconds. High percentages indicate good balance

Study Officials

• Pilar Montero, MD

  Catalan Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: October 7, 2015
• Study Start: September 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

ES (1)