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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06018974
Other study ID # 49/2021
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 13, 2023
Est. completion date March 2024

Study information

Verified date November 2023
Source University of Oulu
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Older people in long-term care (LTC) are often less physically active than their community-dwelling peers. Low physical activity level is associated with more symptoms of anxiety and depression as well as with lower physical performance. This weakens coping with daily activities and increases the care costs. Earlier research have found that playing digital games that require physical activity affects positively functioning of older people. Playing can increase physical activity, improve balance and walking speed, lift the mood and create opportunities for social interaction. The effects of digital gaming, especially on objectively measured physical activity and social functioning, are still unclear. The aim of this study is to evaluate effectiveness of digital gaming intervention with Yetitablet to physical, psychological and social functioning and activity of older people in long-term care environment. This study investigates the effectiveness of the Yetitablet in improving the functioning of older people. Yetitablet is an assistive technology device developed for special groups. Yetitablet is a large interactive touchscreen tablet with 55" screen and with Android operating system and it includes numerous applications. Yetitablet has mobile stand on wheels, which allows the screen to be raised and lowered, as well as tilted as needed, all the way to a desk position. Applications can be downloaded to the device from the Google Play Store, and it also has its own game applications, such as darts, table hockey and memory game. These games can be played individually or in group. There is no previous scientific research on the effectiveness of the Yetitablet on the functioning and activity of older people in long-term care settings.


Description:

Sample size calculation was completed based on an effect size of 0.3 (power = 0.80; α= 0.05). Assuming a 25% attrition rate, a total of 70 residents will be recruited (35 people in a control group and 35 people in the intervention group). Participants will be recruited from LTC facilities for older people in the region of Oulu in northern Finland. Facilities will be selected by purposeful sampling. Participants will be selected by personnel of the facilities purposefully based on the inclusion criteria. After being informed about the study all suitable residents willing to participate in this study will undergo baseline functional testing on week 0. Same functional measurements will be conducted after three month intervention period. Baseline physical activity will be measured by activity tracker during one week before intervention and during the intervention (3 months). In addition, approximately 10-15 LTC facility personnel will be recruited for semi-structured group interviews to understand more of the effects of Yetitablet to psychological and social functioning as well as social activity of LTC residents. The interviews will also clarify the staff's experiences of using the Yetitablet and its suitability for the everyday life of the facility.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 70
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - lives in a long-term care facility for older people participating in the study - has sufficient cognitive ability to understand the purpose of the study - is able to walk (with or without walking aid) the distance required by physical functioning tests (10m) - no illness restricting light exercise - no serious, acute illness - sufficient cognitive skills to understand game instructions - sufficient functionality of the upper limbs to use the touch screen Exclusion Criteria: - unable to move independently even with walking aid - severe memory disorder or other acute illness - unable to understand game instructions, or able to concentrate on playing games for the required time - too weak vision to play games - unable to use upper limbs to play - simultaneously receiving some other treatment that differs from usual treatment

Study Design


Intervention

Device:
Yetitablet gaming
Playing digital games like bowling, memory games, coordination games ect. with the Yetitablet.

Locations

Country Name City State
Finland University of Oulu Oulu

Sponsors (1)

Lead Sponsor Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

References & Publications (3)

de Oliveira LDSSCB, Souza EC, Rodrigues RAS, Fett CA, Piva AB. The effects of physical activity on anxiety, depression, and quality of life in elderly people living in the community. Trends Psychiatry Psychother. 2019 Jan-Mar;41(1):36-42. doi: 10.1590/2237-6089-2017-0129. Epub 2019 Feb 4. — View Citation

Jantunen H, Wasenius N, Salonen MK, Perala MM, Osmond C, Kautiainen H, Simonen M, Pohjolainen P, Kajantie E, Rantanen T, von Bonsdorff MB, Eriksson JG. Objectively measured physical activity and physical performance in old age. Age Ageing. 2017 Mar 1;46(2):232-237. doi: 10.1093/ageing/afw194. — View Citation

van Santen J, Droes RM, Holstege M, Henkemans OB, van Rijn A, de Vries R, van Straten A, Meiland F. Effects of Exergaming in People with Dementia: Results of a Systematic Literature Review. J Alzheimers Dis. 2018;63(2):741-760. doi: 10.3233/JAD-170667. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in the Timed Up and Go test (TUG) at week 12 Change in mean scores on the Timed-up-and-Go test (Completion time in seconds, faster performance indicate better functioning). Baseline and week 12
Secondary Change from baseline in the Revised Index for Social Engagement (RISE) at week 12 Change in mean RISE points (range 0-6, higher points indicate more social engagement). Baseline and week 12
Secondary Change from baseline in weekly time spent in light to vigorous physical activity Physical activity (weekly time spent in light to vigorous physical activity) measured with wrist-worn physical activity monitor continuously over the 3-month trial 13 weeks
Secondary Change in mood before and after every gaming session Change in mean face scale scores (range 1-5, higher scores indicate better mood). Every gaming session during three month long intervention
Secondary Change from baseline in hand grip strength at week 12 Change in hand grip strength in both hands measured with dynamometer Baseline and week 12
Secondary Change from baseline in the Short Physical Performance Battery (SPPB) at week 12 Change in mean scores on the SPPB test (higher scores indicate better functioning). Baseline and week 12
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