Fall Prevention in Healthy AgingActive@HomeNCT03676452
The Effects of an Exergame Training on Body and Brain of Older Adults
A study testing Active@Home exergame training in people with Fall Prevention in Healthy Aging, run by Eling DeBruin at 1 site in Switzerland.
Trial summary
This study investigates the effects of an exergame training including strength, balance, and cognitive training components on motor functions, cognition and brain structure of older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall Prevention in Healthy Aging
- What is being tested?
- Active@Home exergame training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2018to 18 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥ 65 years
- Living independently
- Healthy by self-report
- Able to stand unsupported on feet for at least 10-15 minutes
- Written informed consent signed by the participant
- Not participating in a guided existing physical or cognitive training program
- Possess a TV screen with HDMI connection and some space in front of the screen
Who cannot join
- Cognitive impairments (Mini Mental State Examination, MMSE ≤ 23)
- Severe health problems (e.g. recent cardiac infarction, uncontrolled diabetes or uncontrolled hypertension)
- Orthopaedic disease leading to mobility impairments (that prevent to stand unsupported on feet for at least 10-15 minutes)
- Neurological disease (e.g. history of stroke or epilepsy, Parkinson disease)
- Alzheimer disease or other forms of dementia
- Acute severe illness
Show all 10Show fewer
- Rapidly progressive or terminal illness
- Intake of any psychoactive substances (neuroleptics, antidepressants etc.) with an influence on neuroplasticity
- Active participation in a guided strength-balance-aerobic endurance or cognitive training program
- Contraindication for MRI: Any metallic parts within the body, metallic or electronic implants (e.g. heart pacemaker, brain pacemaker, cochlear implants), shunts, stents, protheses, ferromagnetic remnants within the body, strong claustrophobia
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Institute of Human Movement Sciences and Sport, ETH Zurich
Zurich, 8093
About this study
Official title: The Effects of a Home-based Multicomponent Exergame Training on Motor Functions, Cognition, and Brain Structure of Older Adults: A Multinational Randomized Controlled Trial
This study investigates the effects of an exergame training including strength, balance, and cognitive training components on motor functions, cognition and brain structure of older adults. The primary objective is to determine the effects of the home-based multicomponent exergame training on motor and cognitive functions of older adults compared to a usual care waitlist control group. To understand the underlying mechanisms, the secondary objective is to assess the effect of the exergame training on neuronal level (brain structure). The study design is a randomized controlled trial including 40 healthy (self-reported), independently living older adults aged 65 years and older. The intervention period lasts for 16-18 weeks (no longer than two weeks of break/holiday allowed) with three training sessions per week each lasting about 40 minutes.
Read the detailed description
Age-associated degenerative changes cause gait impairments and a higher risk of falls in elderly. Falls are a leading cause for injuries, reduced mobility, independence and general well-being. Most of the investigator's daily life activities, including walking, are tasks which require not only motor but also cognitive functions. Therefore, also in fall prevention, there is a need for combined motor-cognitive interventions. Exergames - games which require physical activity and movement to play the game - are a promising option for motivating and engaging motor-cognitive training, especially in combination with newly available technologies. In an international project of the Ambient Assisted Living Association (AAL), a new exergame (Active@Home) was developed which ultimately aims for fall prevention in elderly and incorporates theoretical background from movement sciences, neuropsychology, cognitive sciences, and arts of game design.
During aging, age-related changes are evident not only in sensory, motor and cognitive functions but also on (underlying) neuronal level: The aging brain is associated with neurostructural changes and functional changes in neuronal activity pattern. Especially the (pre)frontal lobe and medial temporal lobe (Hippocampus) are vulnerable to age-related degeneration. However, also in higher age, experience-based neuroplasticity can be observed; the adult brain possesses the ability to alter cortical functions and structures in response to stimulation or training. Evidence shows that experience-dependent neural plasticity can be enhanced by both, physical and cognitive exercise. The question arises how a combination of both - combined motor-cognitive training - influences neuroplasticity in the aging brain. Exergame training has been shown to improve motor as well as cognitive functions. To understand the underlying mechanisms of these training effects, the impact on the level of neuronal activity and brain structure has to be studied.
The primary objective of this study is to determine the effects of a home-based multicomponent exergame training on motor and cognitive functions of older adults compared to a usual care waitlist control group.
To understand the underlying mechanisms, the secondary objective is to assess the effect of the exergame training on neuronal level (brain structure).
The Active@Home exergame is a multicomponent, motor-cognitive training for fall prevention in elderly adults. It mainly consists of three components; strength training, balance training and cognitive training. For strength training, Tai Chi-based movements are included as Tai Chi is mainly performed in a semi-squat posture that places a large load on the muscles of the lower extremities. For balance training, dancing is included in the Active@Home exergame as the execution of rapid and well-directed steps has been shown to be effective in preventing falls. Both, Tai Chi and dancing, are 'holistic' physical activities requiring motor functions, cognition and mental involvement. Moreover, the Active@Home exergame explicitly targets specific attentional and executive functions (selective attention, divided attention, inhibition/interference control, mental flexibility, working memory) which are important for walking and safe gait. To maximize benefits for participants, the Active@Home exergame implements some basic general training principles; providing feedback, optimal load of task demands, progression of difficulty and high variability. The Active@Home system set up is easy and consists of an HDMI dongle (to run the application) which must be plugged into the TV and four wearable sensors (to measure the movements).
All interested participants will be screened for eligibility for the study (cognitive screening with MMSE, health screening with questionnaire). Then the eligible participants are randomly allocated to either the intervention group or the waitlist control group. At the first appointment (T1), pre-measurements are conducted (motor and cognitive functions, MRI scans) with all participants. The participants of the intervention group will be equipped with the Active@Home exergame kit and instructed how to set up and use the system at home. The intervention period lasts for 16-18 weeks (no longer than two weeks of break/holiday allowed) with three training sessions per week each lasting about 40 minutes. All participants have to fill in an activity protocol during the whole intervention period. After completing all training sessions (in the intervention group), post-measurements are conducted at T2 with all participants. Measurements will take place at the CERENEO (Swiss clinic and research institute at Vitznau, Lucerne). Participants of the waitlist control group are instructed to continue their usual daily business and activities during the study period. After the post-measurements, they will get the Active@Home exergame for their personal use at home (for several months).
- Conditions
- Fall Prevention in Healthy Aging
- Being tested
- Active@Home exergame training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active@Home exergame trainingBehavioural
The Active@Home exergame is a multicomponent, motor-cognitive training for fall prevention in elderly adults. It mainly consists of three components; strength training, balance training and cognitive training. For strength training, Tai Chi-based movements are included. For balance training, dancing is included in the Active@Home exergame. Moreover, the Active@Home exergame explicitly targets specific attentional and executive functions. The Active@Home system set up is easy and consists of an HDMI dongle (to run the application) which must be plugged into the TV and four wearable sensors (to measure the movements).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants of the intervention group train for 16 weeks (three times per week) with a multicomponent virtual reality-based exergame at their home. The Active@Home exergame contains strength training with Tai Chi-based exercises, balance training with dancing and a cognitive training with specific cognitive-motor games. Each training session lasts about 30 to 40 minutes. Receives: Behavioral: Active@Home exergame training |
| Control group | No intervention | Participants of the control group go on with their usual daily life. After post-measurements, they get the Active@Home exergame to use the training system at home. They don't have to follow a specific training plan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait speed
Gait analysis is conducted under single- and dual-task condition and temporal-spatial gait parameters (gait speed, step length, toe clearance) are measured. Gait analysis is conducted with the Physilog. Gait speed is measured in m/s.
Measured: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 5 minutes.
Change in balance
To assess balance, the balance test of the Short Physical Performance Battery (SPPB) is used resulting an a total score of 4 points for the balance tasks (e.g. tandem stance, semit tandem stance, single leg stance). A higher score means a better balance performance.
Measured: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The balance test lasts 3 minutes.
Change in lower body strength
Lower body strength is measured by the 30 Seconds Chair Rises Test of the Senior Fitness Test (SFT) resulting in a number of chair rises participants can perform in 30 seconds.
Measured: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The lower body strength test lasts 1 minute.
Change in aerobic endurance
Aerobic endurance is assessed by the 2 Minutes Stepping Test of the Senior Fitness Test (SFT) resulting in a number of steps done by the participants in 2 minutes.
Measured: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The aerobic endurance test lasts 3 minutes.
Change in step length
Gait analysis is conducted under single- and dual-task condition and temporal-spatial gait parameters (gait speed, step length, toe clearance) are measured. Gait analysis is conducted with the Physilog. Step length is measured in m.
Measured: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 5 minutes.
Change in minimal toe clearance
Gait analysis is conducted under single- and dual-task condition and temporal-spatial gait parameters (gait speed, step length, toe clearance) are measured. Gait analysis is conducted with the Physilog. Minimal toe clearance is measured in cm. Smaller values are related to higher risk of tripping and falling.
Measured: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 5 minutes.
Change in mental flexibility
To assess mental flexibility (a part of executive functions), the Trail Making Test (TMT) is used pre- and post-intervention. This paper-pencil-test is resulting in a time value in seconds. Less time needed to conducted the test is related to better performance.
Measured: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The TMT lasts 5 minutes.
Change in interference control
To assess interference control (a part of executive functions), the Victoria Stroop Test (VST) is used pre- and post-intervention. The result is a time value measured in seconds, furthermore, errors are counted. Less time and less errors is related to better performance.
Measured: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The VST lasts 5 minutes.
Change in memory functions
To assess memory functions, the Wechsler-Memory-Sclae-Revised (WMS-R) is used pre- and post-intervention. The test is resulting in a point score. The maximal point score is 12 points, the minimal point score is 0. Higher scores are related to better performance.
Measured: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The WMS-R lasts 5 minutes.
Secondary outcomes (2)
Change in grey matter brain structure
Grey matter brain structure is assessed by structural MRI scan with T1-weighted sequence. The focus of the analysis will be on (pre)frontal structures, the hippocampus and the cerebellum.
Measured: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The T1-weighted sequence lasts 5 minutes.
Change in white matter brain structure
White matter brain structure is assessed by structural MRI scan with T2-weighted sequence. The focus is on white matter hyper intensities in the whole brain.
Measured: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The T2-weighted sequences last 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 Jul 2018
- Primary completion18 Apr 2019
- Study completion18 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall Prevention in Healthy AgingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a two-arm randomized controlled trial with an intervention group and a usual care waitlist control group. After pre-measurement, participants of the intervention group train for four months with the Active@Home exergame. Participants of the control group are instructed to continue their usual daily business and activities. Then, post-measurement takes place. After post-measurement, participants of the control group get the Active@Home exergame for their personal use at home (for several months, no additional measurement).
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eling DeBruin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eling DeBruin, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676452
- Sponsor's protocol ID
- BASEC-Nr. 2018-00510
- Acronym
- Active@Home
- Status last verified
- Apr 2019
- First submitted
- 27 Aug 2018
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Home-based Multicomponent Exergame Training on Motor Functions, Cognition, and Brain Structure of Older Adults: A Multinational Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03676452
- Acronym / sponsor ID
- Active@Home / BASEC-Nr. 2018-00510
- Conditions
- Fall Prevention in Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Eling DeBruinUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 18 Apr 2019 (actual)
- First posted
- 18 Sep 2018 (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.
This study investigates the effects of an exergame training including strength, balance, and cognitive training components on motor functions, cognition and brain structure of older adults. The primary objective is to determine the effects of the home-based multicomponent exergame training on motor and cognitive functions of older adults compared to a usual care waitlist control group. To understand the underlying mechanisms, the secondary objective is to assess the effect of the exergame training on neuronal level (brain structure). The study design is a randomized controlled trial including 40 healthy (self-reported), independently living older adults aged 65 years and older. The intervention period lasts for 16-18 weeks (no longer than two weeks of break/holiday allowed) with three training sessions per week each lasting about 40 minutes.
Detailed description
Age-associated degenerative changes cause gait impairments and a higher risk of falls in elderly. Falls are a leading cause for injuries, reduced mobility, independence and general well-being. Most of the investigator's daily life activities, including walking, are tasks which require not only motor but also cognitive functions. Therefore, also in fall prevention, there is a need for combined motor-cognitive interventions. Exergames - games which require physical activity and movement to play the game - are a promising option for motivating and engaging motor-cognitive training, especially in combination with newly available technologies. In an international project of the Ambient Assisted Living Association (AAL), a new exergame (Active@Home) was developed which ultimately aims for fall prevention in elderly and incorporates theoretical background from movement sciences, neuropsychology, cognitive sciences, and arts of game design.
During aging, age-related changes are evident not only in sensory, motor and cognitive functions but also on (underlying) neuronal level: The aging brain is associated with neurostructural changes and functional changes in neuronal activity pattern. Especially the (pre)frontal lobe and medial temporal lobe (Hippocampus) are vulnerable to age-related degeneration. However, also in higher age, experience-based neuroplasticity can be observed; the adult brain possesses the ability to alter cortical functions and structures in response to stimulation or training. Evidence shows that experience-dependent neural plasticity can be enhanced by both, physical and cognitive exercise. The question arises how a combination of both - combined motor-cognitive training - influences neuroplasticity in the aging brain. Exergame training has been shown to improve motor as well as cognitive functions. To understand the underlying mechanisms of these training effects, the impact on the level of neuronal activity and brain structure has to be studied.
The primary objective of this study is to determine the effects of a home-based multicomponent exergame training on motor and cognitive functions of older adults compared to a usual care waitlist control group.
To understand the underlying mechanisms, the secondary objective is to assess the effect of the exergame training on neuronal level (brain structure).
The Active@Home exergame is a multicomponent, motor-cognitive training for fall prevention in elderly adults. It mainly consists of three components; strength training, balance training and cognitive training. For strength training, Tai Chi-based movements are included as Tai Chi is mainly performed in a semi-squat posture that places a large load on the muscles of the lower extremities. For balance training, dancing is included in the Active@Home exergame as the execution of rapid and well-directed steps has been shown to be effective in preventing falls. Both, Tai Chi and dancing, are 'holistic' physical activities requiring motor functions, cognition and mental involvement. Moreover, the Active@Home exergame explicitly targets specific attentional and executive functions (selective attention, divided attention, inhibition/interference control, mental flexibility, working memory) which are important for walking and safe gait. To maximize benefits for participants, the Active@Home exergame implements some basic general training principles; providing feedback, optimal load of task demands, progression of difficulty and high variability. The Active@Home system set up is easy and consists of an HDMI dongle (to run the application) which must be plugged into the TV and four wearable sensors (to measure the movements).
All interested participants will be screened for eligibility for the study (cognitive screening with MMSE, health screening with questionnaire). Then the eligible participants are randomly allocated to either the intervention group or the waitlist control group. At the first appointment (T1), pre-measurements are conducted (motor and cognitive functions, MRI scans) with all participants. The participants of the intervention group will be equipped with the Active@Home exergame kit and instructed how to set up and use the system at home. The intervention period lasts for 16-18 weeks (no longer than two weeks of break/holiday allowed) with three training sessions per week each lasting about 40 minutes. All participants have to fill in an activity protocol during the whole intervention period. After completing all training sessions (in the intervention group), post-measurements are conducted at T2 with all participants. Measurements will take place at the CERENEO (Swiss clinic and research institute at Vitznau, Lucerne). Participants of the waitlist control group are instructed to continue their usual daily business and activities during the study period. After the post-measurements, they will get the Active@Home exergame for their personal use at home (for several months).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-arm randomized controlled trial with an intervention group and a usual care waitlist control group. After pre-measurement, participants of the intervention group train for four months with the Active@Home exergame. Participants of the control group are instructed to continue their usual daily business and activities. Then, post-measurement takes place. After post-measurement, participants of the control group get the Active@Home exergame for their personal use at home (for several months, no additional measurement).
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Active@Home exergame trainingParticipants of the intervention group train for 16 weeks (three times per week) with a multicomponent virtual reality-based exergame at their home. The Active@Home exergame contains strength training with Tai Chi-based exercises, balance training with dancing and a cognitive training with specific cognitive-motor games. Each training session lasts about 30 to 40 minutes. |
| Control group | No intervention | –Participants of the control group go on with their usual daily life. After post-measurements, they get the Active@Home exergame to use the training system at home. They don't have to follow a specific training plan. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age ≥ 65 years
- Living independently
- Healthy by self-report
- Able to stand unsupported on feet for at least 10-15 minutes
- Written informed consent signed by the participant
Key exclusion criteria (10 listed)
- Cognitive impairments (Mini Mental State Examination, MMSE ≤ 23)
- Severe health problems (e.g. recent cardiac infarction, uncontrolled diabetes or uncontrolled hypertension)
- Orthopaedic disease leading to mobility impairments (that prevent to stand unsupported on feet for at least 10-15 minutes)
- Neurological disease (e.g. history of stroke or epilepsy, Parkinson disease)
- Alzheimer disease or other forms of dementia
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 |
|---|---|---|
| Active@Home exergame trainingThe Active@Home exergame is a multicomponent, motor-cognitive training for fall prevention in elderly adults. It mainly consists of three components; strength training, balance training and cognitive training. For strength training, Tai Chi-based movements are included. For balance training, dancing is included in the Active@Home exergame. Moreover, the Active@Home exergame explicitly targets specific attentional and executive functions. The Active@Home system set up is easy and consists of an HDMI dongle (to run the application) which must be plugged into the TV and four wearable sensors (to measure the movements). | Behavioural | Intervention group |
Primary outcome
Change in gait speed
Time frame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 5 minutes.
Gait analysis is conducted under single- and dual-task condition and temporal-spatial gait parameters (gait speed, step length, toe clearance) are measured. Gait analysis is conducted with the Physilog. Gait speed is measured in m/s.
Change in balance
Time frame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The balance test lasts 3 minutes.
To assess balance, the balance test of the Short Physical Performance Battery (SPPB) is used resulting an a total score of 4 points for the balance tasks (e.g. tandem stance, semit tandem stance, single leg stance). A higher score means a better balance performance.
Change in lower body strength
Time frame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The lower body strength test lasts 1 minute.
Lower body strength is measured by the 30 Seconds Chair Rises Test of the Senior Fitness Test (SFT) resulting in a number of chair rises participants can perform in 30 seconds.
Change in aerobic endurance
Time frame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The aerobic endurance test lasts 3 minutes.
Aerobic endurance is assessed by the 2 Minutes Stepping Test of the Senior Fitness Test (SFT) resulting in a number of steps done by the participants in 2 minutes.
Change in step length
Time frame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 5 minutes.
Gait analysis is conducted under single- and dual-task condition and temporal-spatial gait parameters (gait speed, step length, toe clearance) are measured. Gait analysis is conducted with the Physilog. Step length is measured in m.
Change in minimal toe clearance
Time frame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 5 minutes.
Gait analysis is conducted under single- and dual-task condition and temporal-spatial gait parameters (gait speed, step length, toe clearance) are measured. Gait analysis is conducted with the Physilog. Minimal toe clearance is measured in cm. Smaller values are related to higher risk of tripping and falling.
Change in mental flexibility
Time frame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The TMT lasts 5 minutes.
To assess mental flexibility (a part of executive functions), the Trail Making Test (TMT) is used pre- and post-intervention. This paper-pencil-test is resulting in a time value in seconds. Less time needed to conducted the test is related to better performance.
Change in interference control
Time frame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The VST lasts 5 minutes.
To assess interference control (a part of executive functions), the Victoria Stroop Test (VST) is used pre- and post-intervention. The result is a time value measured in seconds, furthermore, errors are counted. Less time and less errors is related to better performance.
Change in memory functions
Time frame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The WMS-R lasts 5 minutes.
To assess memory functions, the Wechsler-Memory-Sclae-Revised (WMS-R) is used pre- and post-intervention. The test is resulting in a point score. The maximal point score is 12 points, the minimal point score is 0. Higher scores are related to better performance.
2 secondary outcomes
Change in grey matter brain structure
Time frame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The T1-weighted sequence lasts 5 minutes.
Change in white matter brain structure
Time frame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The T2-weighted sequences last 10 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active@Home exergame training in people with Fall Prevention in Healthy Aging, run by Eling DeBruin at 1 site in Switzerland.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 19 Apr 2019. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gait speed (time frame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 5 minutes.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2019.