Clinical trial NCT06711393: The Effectiveness of Exergaming for Older People Mobility and Balance
Official title: The Effectiveness of Exergaming (YetiHome®) Versus Traditional Exercise for Older People Mobility and Balance: Protocol of the Randomized Intervention Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mobility Limitation
Keywords: Older adults
Balance
Mobility limitation
Preclinical mobility limitation
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 100
Sex: ALL
Minimum age (years): 75
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The mobility problems of older people are often related to the decrease of functional capacity and health \[1\], weakened physical condition, attitude to life and fear of falling \[2\]. Relatively little research has been done on the possibilities and effectiveness of exergaming on the mobility of old people. Interventions that include exergaming have been found to motivate and increase commitment to rehabilitation \[3\], to improve mobility, balance \[4\], performance in daily activities and independence \[5\].

The aim of randomized intervention trial is to find out the effect of physical exercises performed on the technological device (YetiHome®) on identified preclinical movement problems during a 2-month follow-up period. The goal is to produce information about the effectiveness of gamified physical exercises in preventing movement problems and supporting older people living at home.

This study investigates the effectiveness of the YetiHome in improving the physical functioning of older people. YetiHome is an assistive technology device developed for special groups. YetiHome is a small interactive touchscreen tablet with 27" screen and with Android operating system and it includes numerous applications. Added exergaming solution for the balance training. There is no previous scientific research on the effectiveness of the YetiHome on the mobility problems and activity of the community-dwelling older people living independently at home.

The aim of randomized intervention trial is to find out the effect of physical exercises performed on the technological device (YetiHome®) on identified preclinical movement problems during a 2-month follow-up period. The goal is to produce information about the effectiveness of gamified physical exercises in preventing movement problems and supporting older people living at home.

This study investigates the effectiveness of the YetiHome in improving the physical functioning of older people. YetiHome is an assistive technology device developed for special groups. YetiHome is a small interactive touchscreen tablet with 27" screen and with Android operating system and it includes numerous applications. Added exergaming solution for the balance training. There is no previous scientific research on the effectiveness of the YetiHome on the mobility problems and activity of the community-dwelling older people living independently at home.

Detailed description: Sample size calculation was completed based on an effect size of 0.35 (power = 0.80; α= 0.05). Assuming a 35% attrition rate, a total of 100 participants will be recruited (50 people in a control group and 50 people in the intervention group). The target group is 75 old people, who are not covered by social and health services and who have received a preventive home visit in the region of Kemi in northern Finland. The intervention groups consist of people who have been found to have preclinical mobility problems during a preventive home visit.

After being informed about the study all suitable participants of the preventive home visit willing to participate in this study will undergo baseline functional testing on week 0. Same functional measurements will be conducted after two-month intervention period. Baseline data collection of functional capacity utilizes the structured questionnaire (HEKO-tool), whose functional assessment targets are bridged to the ICF classification (International Classification of Functioning, Disability and Health). Data is collected on everyday activities as well as mental-wellbeing, social-wellbeing and risk of falls. In the second phase, the physical performance was assessed by a One-Leg Balance test (OLB) and Short Physical Performance test (SPPB) combined with a mobile solution developed to measure balance, AinoneBalance. The AinoneBalance application utilizes Romberg's standardized test. The participants were randomized into a game group and a control group. The gaming group received a YetiHome® device at home and instructions for the traditional exercise. The control group only received instructions for the traditional exercise.

Eligibility criteria: Inclusion Criteria:

* Living at home.
* Not a user of health and social services.
* Sufficient cognitive ability to do exercises independently.

Exclusion Criteria:

* Risk of hip fracture and inability to perform exercise independently.

Primary outcomes:
measure: Balance Short Physical Performance Battery (SPPB)
timeFrame: From baseline to the end of intervention at 8 weeks
measure: One Leg Balance (OLB)
timeFrame: From baseline to the end of intervention at 8 weeks
measure: Mobility
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Research unit of health sciences and technology
Study officials:
affiliation: University of Oulu
name: Satu Elo Elo, PhD, Adjunct professor, Principal lecturer
role: STUDY_DIRECTOR
References:
citation: Neumann S, Meidert U, Barbera-Guillem R, Poveda-Puente R, Becker H. Effects of an Exergame Software for Older Adults on Fitness, Activities of Daily Living Performance, and Quality of Life. Games Health J. 2018 Oct;7(5):341-346. doi: 10.1089/g4h.2017.0079.
citation: Pacheco TBF, de Medeiros CSP, de Oliveira VHB, Vieira ER, de Cavalcanti FAC. Effectiveness of exergames for improving mobility and balance in older adults: a systematic review and meta-analysis. Syst Rev. 2020 Jul 18;9(1):163. doi: 10.1186/s13643-020-01421-7.
citation: Oesch P, Kool J, Fernandez-Luque L, Brox E, Evertsen G, Civit A, Hilfiker R, Bachmann S. Exergames versus self-regulated exercises with instruction leaflets to improve adherence during geriatric rehabilitation: a randomized controlled trial. BMC Geriatr. 2017 Mar 23;17(1):77. doi: 10.1186/s12877-017-0467-7.
citation: Pauelsen M, Nyberg L, Roijezon U, Vikman I. Both psychological factors and physical performance are associated with fall-related concerns. Aging Clin Exp Res. 2018 Sep;30(9):1079-1085. doi: 10.1007/s40520-017-0882-9. Epub 2017 Dec 20.