Mobility LimitationYetiExergameNCT06711393
The Effectiveness of Exergaming for Older People Mobility and Balance
A study testing Exercise and Exercise as usual in people with Mobility Limitation, run by University of Oulu at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- Exercise and Exercise as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 27 Nov 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Living at home.
- Not a user of health and social services.
- Sufficient cognitive ability to do exercises independently.
Who cannot join
- Risk of hip fracture and inability to perform exercise independently.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Satu Elo, PhD, Adjunct professor, Principal lecturer contact
About this study
Official title: The Effectiveness of Exergaming (YetiHome®) Versus Traditional Exercise for Older People Mobility and Balance: Protocol of the Randomized Intervention Trial
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.
Read more
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.
Read the 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.
- Conditions
- Mobility Limitation
- Being tested
- Exercise, Exercise as usual
- Keywords
- Older adults, Balance, Mobility limitation, Preclinical mobility limitation
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Traditional home exercise including balance and muscle strength training 15 minutes at the time and three times over the week. In addition, game-based exercises 15 minutes at the time and three times over the week.
Exercise as usualOther
Traditional home exercise including balance and muscle strength training 15 minutes at the time and three times over the week without exergaming.
| Study group | Role | What they receive |
|---|---|---|
| Exergaming group | Experimental | Exergaiming group plaing games during intervention period Receives: Other: Exercise |
| Control group | Active comparator | Regular exercise without exergaming Receives: Other: Exercise as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Short Physical Performance Battery (SPPB)
Short Physical Performance Battery (SPPB), Scores range from 0 to 12. The lower the SPPB total score, the greater the risk of future mobility.
Measured: From baseline to the end of intervention at 8 weeks
One Leg Balance (OLB)
AinoneBalance -solution, Movement path length. Standing 10 seconds with feet together, semi tandem, tandem, the eyes open and closed, on hard and soft surface.
Measured: From baseline to the end of intervention at 8 weeks
Mobility
Short Physical Performance Battery (SPPB), Scores range from 0 to 12. The lower the SPPB total score, the greater the risk of future mobility.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start27 Nov 2024 (estimated)
- Primary completion20 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sari Arolaakso, University of Oulu
- Investigators
- Satu Elo Elo, PhD, Adjunct professor, Principal lecturer, Study director, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711393
- Sponsor's protocol ID
- 61/2023
- Acronym
- YetiExergame
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30325234Pacheco 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.
PubMed 32682439Oesch 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.
PubMed 28330455Pauelsen 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.
PubMed 29264814
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Exergaming (YetiHome®) Versus Traditional Exercise for Older People Mobility and Balance: Protocol of the Randomized Intervention Trial
- ClinicalTrials.gov ID
- NCT06711393
- Acronym / sponsor ID
- YetiExergame / 61/2023
- Conditions
- Mobility Limitation
- Keywords
- Older adults, Balance, Mobility limitation, Preclinical mobility limitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 27 Nov 2024 (estimated)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergaming group | Experimental | Other: ExerciseExergaiming group plaing games during intervention period |
| Control group | Active comparator | Other: Exercise as usualRegular exercise without exergaming |
Who may qualify
- Ages
- 75 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Living at home.
- Not a user of health and social services.
- Sufficient cognitive ability to do exercises independently.
Key exclusion criteria (1 listed)
- Risk of hip fracture and inability to perform exercise independently.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseTraditional home exercise including balance and muscle strength training 15 minutes at the time and three times over the week. In addition, game-based exercises 15 minutes at the time and three times over the week. | Other | Exergaming group |
| Exercise as usualTraditional home exercise including balance and muscle strength training 15 minutes at the time and three times over the week without exergaming. | Other | Control group |
Primary outcome
Balance Short Physical Performance Battery (SPPB)
Time frame: From baseline to the end of intervention at 8 weeks
Short Physical Performance Battery (SPPB), Scores range from 0 to 12. The lower the SPPB total score, the greater the risk of future mobility.
One Leg Balance (OLB)
Time frame: From baseline to the end of intervention at 8 weeks
AinoneBalance -solution, Movement path length. Standing 10 seconds with feet together, semi tandem, tandem, the eyes open and closed, on hard and soft surface.
Mobility
Time frame: From enrollment to the end of treatment at 8 weeks
Short Physical Performance Battery (SPPB), Scores range from 0 to 12. The lower the SPPB total score, the greater the risk of future mobility.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Background: PubMed 30325234Neumann 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.
- Background: PubMed 32682439Pacheco 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.
- Background: PubMed 28330455Oesch 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.
- Background: PubMed 29264814Pauelsen 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.
- GeroNursing Center, Research unit of health sciences and technology, University of OuluLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Satu Elo, PhD, Adjunct professor, Principal lecturer contact
Satu Elo Elo, PhD, Adjunct professor, Principal lecturer study director
University of Oulu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Exercise as usual in people with Mobility Limitation, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sari Arolaakso Senior Lecturer, PhD Student (+358 503109334, Sari.J.Arolaakso@student.oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Short Physical Performance Battery (SPPB) (time frame: From baseline to the end of intervention at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06711393, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.