Major Neurocognitive DisorderGameDementiaNCT06631742
Exergaming Revolution in Dementia
A study testing Exergaming on Dividat Senso in people with Major Neurocognitive Disorder and Alzheimer Disease, run by Eastern Switzerland University of Applied Sciences at 1 site in Switzerland.
Trial summary
This pilot randomized controlled trial evaluates the effect of a 12 weeks exergaming training in people with major neurocognitive disorders (MNCD) living in long-term care facilities. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Major Neurocognitive Disorder, Alzheimer Disease, Parkinson Disease
- What is being tested?
- Exergaming on Dividat Senso
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Sep 2024to 30 Apr 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Neurocognitive disorder based on Alzheimer's Disease, Parkinson's disease, Lewy body dementia or Mixed dementia according to the criteria of the American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5)
- Mini-Mental-Status-Examination (MMSE) Score of ≥5 and ≤26 out of e maximum of 30
Who cannot join
- MMSE <5
- Unstable cardiovascular condition or other medical condition that does not allow for safe participation according to the recommendations of the American College of Sports Medicine
- Planned transfer to another facility within the next 3 months
- Acute behavioural problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Sonnweid AG
Wetzikon, Canton of Zurich, 8620
Markus Baumgartner, PD
About this study
Official title: The Effect of an Exergaming Intervention on Physical Activity and Sleep in People With Major Neurocognitive Disorders Living in Long-term Care Facilities: a Pilot Randomized Controlled Trial.
This pilot randomized controlled trial evaluates the effect of a 12 weeks exergaming training in people with major neurocognitive disorders (MNCD) living in long-term care facilities.
Read the detailed description
Background: Major neurocogntivie disorders (MNCD) are categorised as public health priority by the World Health Organisation. To date, there are no disease-modifying treatments that can cure MNCD or effectively halt its progression. However, lifestyle changes that increase physical activity and/or reduce vascular risk factors are effective in protecting against brain atrophy and cognitive decline. Therefore, it has been suggested to focus on non-pharmacological therapies that target people\'s lifestyle, such as multimodal treatment strategies that encompass multiple domains, including physical exercise and cognitive stimulation. Exergames which combine exercise with feedback on performance, fun, relaxation and socialising, are promising for older people.
The goal of this pilot randomized controlled trial is to evaluate the effect of an exergaming intervention in people with MNCD. The main questions it aims to answer are:
- How does an exergaming intervention effects gait speed, cognitive and motor functions as well as depressive symptoms and quality of life in residents of a long-term care facilities.
- How does an exergaming intervention effects physical activity and sleep in residents of a long-term care facilities.
Methods: Investigators plan to include 48 participants living in long-term care facilities. Participants will participate in a 12 weeks active dance video game (3x 15minute per week) or will get care as usual. The Short Physical Perfomance Battery (SPPB), The Montréal Cognitive Assessment (MoCA), Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), Quality of Life in Alzheimer\'s (QoL-AD), Katz activities of daily living (Katz-ADL), Geriatric Sleep Questionnaire (GSQ-6), number\'s of falls in the last 12 weeks, physical activity and sleep parameters of the motions sensor GENEactiv and sleep parameters of the contacless sensorbox Sleepiz are measured at baseline and post intervention.
For all outcomes, descriptive statistics will be computed first. Normality distribution of data will be checked using the Shapiro-Wilk test and Q-Q-plots. The assumptions of homogeneity of variance and of sphericity will be checked using Levene's test and Mauchly's test, respectively. In case all assumptions are met, a two-way analysis of covariance (ANCOVA) will be computed for all primary and secondary outcomes with the pre-test as covariate for the predicting group factor and the posttest as outcome variable. Therefore, the outcome is the differences of the pre- and post-test with the baseline as the influencing variable. In case not all assumptions for ANCOVA are met, Quade non-parametric tests will be used. The level of significance will be set to p ≤ 0.05 (two-sided).
- Conditions
- Major Neurocognitive Disorder, Alzheimer Disease, Parkinson Disease, Lewy Body Dementia, Mixed Dementias
- Being tested
- Exergaming on Dividat Senso, Usual Care
- Medical subject headings
- Alzheimer Disease, Parkinson Disease, Lewy Body Disease, Mixed Dementias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergaming on Dividat SensoOther
The active dance video game is played with the Dividat Senso (Dividat | Senso: cognitive-motor training). It consists of a dance disc with four arrows (up, down, left, right), and the game is played on a large screen (which is connected to the PC). The screen indicates which arrow the person should step on, thus controlling the game through body movements. The games give the person feedback in the form of auditory, visual, and somatosensory stimuli.
Usual CareOther
Standardised care with meal service, individual activities (e.g. hiking group, walking group, exercise group, handicrafts, gardening group, singing, painting or lunch) and customized care and support as required.
| Study group | Role | What they receive |
|---|---|---|
| Exergaming | Experimental | Individual active dance game training on Dividat Senso Receives: Other: Exergaming on Dividat Senso |
| Usual Care | Other | Customised care and support as required Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery
The SPPB is developed by the National Institute of Aging (NIA). It is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults (\> 65 years of age). The test battery consists of three physical tasks (walking, sit-to-stand and balance) to assess functional mobility. The test will be performed according to standardised procedure. The maximal total score is 12 and higher total scores indicate a better lower extremity functioning.
Measured: Baseline
Short Phyiscal Performance Battery
The SPPB is developed by the National Institute of Aging (NIA). It is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults (\> 65 years of age). The test battery consists of three physical tasks (walking, sit-to-stand and balance) to assess functional mobility. The test will be performed according to standardised procedure. The maximal total score is 12 and higher total scores indicate a better lower extremity functioning.
Measured: after 12 weeks
Secondary outcomes (9)
Montreal Cognitive Assessment
The MoCA is a objective instrument, which is designed for milder forms of major neurocognitive disorders, contains 12 items to assess seven cognitive domains: memory, language, executive functions, visuospatial skills, attention, concentration, abstraction, calculation, and orientation. The maximal total score is 30 and higher total score indicate less cognitive impairment. A cut-off score of 26 signifies mild cognitive impairment.
Measured: Baseline, after 12 weeks
Neuropsychiatric Inventory Questionnaire
The NPI-Q assesses psychopathological problems and is designed to be a self-administered questionnaire completed by caregivers. The questionnaire screening symptom severity and caregiver distress of the following 12 domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviour, night-time behaviour disturbance, and appetite and eating abnormalities. The symptom severity scale ranging from 1 to 3. The caregiver distress scale ranging from 0 to 5. The NPI total score is calculated by multiplying the frequency and severity rates per domain and adding them up. The total score ranges from 0 to 144, with higher score indicating hight severity and higher distress.
Measured: Baseline, after 12 weeks
Cornell Scale for Depression in Dementia
The observation based CSDD, in the form of an interview with the caregiver assesses symptoms of depression. The CSDD consists of 19 items and each one is scored on a 3-point scale ranging from 0 to 2. Items are clustered into five categories: mood, behavioural disturbance, physical signs, cyclic functions, and ideational disturbance. The maximum score is 38, and higher score indicating more depressive symptoms.
Measured: Baseline, after 12 weeks
Quality of Life in Alzheimer's
The QOL-AD is a brief, 13-item which assesses individual's relationships with friends and family, concerns about finances, physical condition, mood, and an overall assessment of life quality. It is designed to acquire a rating of the patient's Quality of Life from both the patient and the caregiver. It uses simple and straightforward language and responses and includes assessments of the caregivers complete the measure as a questionnaire about their patients' QOL, while patients complete it in interview format about their own QOL. The 13 items are rated on a four-point Likert scale, with 1 being poor and 4 being excellent. Total scores range from 13 to 52. The sum of all items; patient and caregiver reports can be evaluated separately and/or combined into a single score if desired.
Measured: Baseline, after 12 weeks
Katz ADL
The interviewer-administered Katz ADL Index assesses participants' function in terms of level of independence or dependence when performing certain daily living activities. It consists of six items: bathing, dressing, transfers, toileting, continence, and feeding. Each item is scored 0 (dependence) or 1 (independence) with a maximum score of 6, which indicates more independence.
Measured: Baseline, after 12 weeks
Geriatric Sleep Questionnaire
Self-reported Questionnaire assesses overall sleep quality. Item score are summed up with the maximal total score of 30. Higher score indicate poorer sleep quality.
Measured: Baseline, after 12 weeks
Numbers of falls in the last 12 weeks
Numbers of Falls during 12 weeks prior to baseline and during the 12 weeks to follow up according to the patient's medical record will be assessed.
Measured: Baseline, after 12 weeks
Motion Sensor GENEactiv
GENEActiv is a lightweight and waterproof medical device that delivers continuous recording of high-resolution acceleration that allows a person's daily activities to be classified, second by second, in terms of the time spent lying, sitting, standing, stepping and sleep parameters such as total sleep time, sleep efficiency and body temperature (e.g., circadian rhythm).
Measured: Basline, after 12 weeks
Contactless Sensorbox Sleepiz
Radar-based contactless technology measuring body position and respiratory rate.
Measured: Baseline, after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start27 Sep 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Major Neurocognitive DisorderStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Switzerland University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eling de Bruin, Eastern Switzerland University of Applied Sciences
- Investigators
- Eling de Bruin, Prof. Dr., Principal investigator, Eastern Swiss University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631742
- Sponsor's protocol ID
- 2024-00113.
- Acronym
- GameDementia
- Status last verified
- Oct 2024
- First submitted
- 10 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.
PubMed 12021425Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204Bellettiere J, Lamonte MJ, Unkart J, Liles S, Laddu-Patel D, Manson JE, Banack H, Seguin-Fowler R, Chavez P, Tinker LF, Wallace RB, LaCroix AZ. Short Physical Performance Battery and Incident Cardiovascular Events Among Older Women. J Am Heart Assoc. 2020 Jul 21;9(14):e016845. doi: 10.1161/JAHA.120.016845. Epub 2020 Jul 14.
PubMed 32662311Cassidy B, Arena S. The Short Physical Performance Battery as a Predictor of Functional Decline. Home Healthc Now. 2022 May-Jun 01;40(3):168-169. doi: 10.1097/NHH.0000000000001070. No abstract available.
PubMed 35510973Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8.
PubMed 3337862Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.
PubMed 9153155Lindbergh CA, Dishman RK, Miller LS. Functional Disability in Mild Cognitive Impairment: A Systematic Review and Meta-Analysis. Neuropsychol Rev. 2016 Jun;26(2):129-59. doi: 10.1007/s11065-016-9321-5. Epub 2016 Jul 8.
PubMed 27393566Sanford AM. Mild Cognitive Impairment. Clin Geriatr Med. 2017 Aug;33(3):325-337. doi: 10.1016/j.cger.2017.02.005. Epub 2017 May 17.
PubMed 28689566Tisher A, Salardini A. A Comprehensive Update on Treatment of Dementia. Semin Neurol. 2019 Apr;39(2):167-178. doi: 10.1055/s-0039-1683408. Epub 2019 Mar 29.
PubMed 30925610Erickson KI, Raji CA, Lopez OL, Becker JT, Rosano C, Newman AB, Gach HM, Thompson PM, Ho AJ, Kuller LH. Physical activity predicts gray matter volume in late adulthood: the Cardiovascular Health Study. Neurology. 2010 Oct 19;75(16):1415-22. doi: 10.1212/WNL.0b013e3181f88359. Epub 2010 Oct 13.
PubMed 20944075Guure CB, Ibrahim NA, Adam MB, Said SM. Impact of Physical Activity on Cognitive Decline, Dementia, and Its Subtypes: Meta-Analysis of Prospective Studies. Biomed Res Int. 2017;2017:9016924. doi: 10.1155/2017/9016924. Epub 2017 Feb 7.
PubMed 28271072Vancampfort D, Solmi M, Firth J, Vandenbulcke M, Stubbs B. The Impact of Pharmacologic and Nonpharmacologic Interventions to Improve Physical Health Outcomes in People With Dementia: A Meta-Review of Meta-Analyses of Randomized Controlled Trials. J Am Med Dir Assoc. 2020 Oct;21(10):1410-1414.e2. doi: 10.1016/j.jamda.2020.01.010. Epub 2020 Feb 19.
PubMed 32085951Ahlskog JE, Geda YE, Graff-Radford NR, Petersen RC. Physical exercise as a preventive or disease-modifying treatment of dementia and brain aging. Mayo Clin Proc. 2011 Sep;86(9):876-84. doi: 10.4065/mcp.2011.0252.
PubMed 21878600Dimitrov DM, Rumrill PD Jr. Pretest-posttest designs and measurement of change. Work. 2003;20(2):159-65.
PubMed 12671209
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Exergaming Intervention on Physical Activity and Sleep in People With Major Neurocognitive Disorders Living in Long-term Care Facilities: a Pilot Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06631742
- Acronym / sponsor ID
- GameDementia / 2024-00113.
- Conditions
- Major Neurocognitive Disorder, Alzheimer Disease, Parkinson Disease, Lewy Body Dementia, Mixed Dementias
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Eastern Switzerland University of Applied SciencesUniversity, hospital or other
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 8 Oct 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.
This pilot randomized controlled trial evaluates the effect of a 12 weeks exergaming training in people with major neurocognitive disorders (MNCD) living in long-term care facilities.
Detailed description
Background: Major neurocogntivie disorders (MNCD) are categorised as public health priority by the World Health Organisation. To date, there are no disease-modifying treatments that can cure MNCD or effectively halt its progression. However, lifestyle changes that increase physical activity and/or reduce vascular risk factors are effective in protecting against brain atrophy and cognitive decline. Therefore, it has been suggested to focus on non-pharmacological therapies that target people\'s lifestyle, such as multimodal treatment strategies that encompass multiple domains, including physical exercise and cognitive stimulation. Exergames which combine exercise with feedback on performance, fun, relaxation and socialising, are promising for older people.
The goal of this pilot randomized controlled trial is to evaluate the effect of an exergaming intervention in people with MNCD. The main questions it aims to answer are:
- How does an exergaming intervention effects gait speed, cognitive and motor functions as well as depressive symptoms and quality of life in residents of a long-term care facilities.
- How does an exergaming intervention effects physical activity and sleep in residents of a long-term care facilities.
Methods: Investigators plan to include 48 participants living in long-term care facilities. Participants will participate in a 12 weeks active dance video game (3x 15minute per week) or will get care as usual. The Short Physical Perfomance Battery (SPPB), The Montréal Cognitive Assessment (MoCA), Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), Quality of Life in Alzheimer\'s (QoL-AD), Katz activities of daily living (Katz-ADL), Geriatric Sleep Questionnaire (GSQ-6), number\'s of falls in the last 12 weeks, physical activity and sleep parameters of the motions sensor GENEactiv and sleep parameters of the contacless sensorbox Sleepiz are measured at baseline and post intervention.
For all outcomes, descriptive statistics will be computed first. Normality distribution of data will be checked using the Shapiro-Wilk test and Q-Q-plots. The assumptions of homogeneity of variance and of sphericity will be checked using Levene's test and Mauchly's test, respectively. In case all assumptions are met, a two-way analysis of covariance (ANCOVA) will be computed for all primary and secondary outcomes with the pre-test as covariate for the predicting group factor and the posttest as outcome variable. Therefore, the outcome is the differences of the pre- and post-test with the baseline as the influencing variable. In case not all assumptions for ANCOVA are met, Quade non-parametric tests will be used. The level of significance will be set to p ≤ 0.05 (two-sided).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergaming | Experimental | Other: Exergaming on Dividat SensoIndividual active dance game training on Dividat Senso |
| Usual Care | Other | Other: Usual CareCustomised care and support as required |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Neurocognitive disorder based on Alzheimer's Disease, Parkinson's disease, Lewy body dementia or Mixed dementia according to the criteria of the American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5)
- Mini-Mental-Status-Examination (MMSE) Score of ≥5 and ≤26 out of e maximum of 30
Key exclusion criteria (4 listed)
- MMSE <5
- Unstable cardiovascular condition or other medical condition that does not allow for safe participation according to the recommendations of the American College of Sports Medicine
- Planned transfer to another facility within the next 3 months
- Acute behavioural problems
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 |
|---|---|---|
| Exergaming on Dividat SensoThe active dance video game is played with the Dividat Senso (Dividat | Senso: cognitive-motor training). It consists of a dance disc with four arrows (up, down, left, right), and the game is played on a large screen (which is connected to the PC). The screen indicates which arrow the person should step on, thus controlling the game through body movements. The games give the person feedback in the form of auditory, visual, and somatosensory stimuli. | Other | Exergaming |
| Usual CareStandardised care with meal service, individual activities (e.g. hiking group, walking group, exercise group, handicrafts, gardening group, singing, painting or lunch) and customized care and support as required. | Other | Usual Care |
Primary outcome
Short Physical Performance Battery
Time frame: Baseline
The SPPB is developed by the National Institute of Aging (NIA). It is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults (\> 65 years of age). The test battery consists of three physical tasks (walking, sit-to-stand and balance) to assess functional mobility. The test will be performed according to standardised procedure. The maximal total score is 12 and higher total scores indicate a better lower extremity functioning.
Short Phyiscal Performance Battery
Time frame: after 12 weeks
The SPPB is developed by the National Institute of Aging (NIA). It is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults (\> 65 years of age). The test battery consists of three physical tasks (walking, sit-to-stand and balance) to assess functional mobility. The test will be performed according to standardised procedure. The maximal total score is 12 and higher total scores indicate a better lower extremity functioning.
9 secondary outcomes
Montreal Cognitive Assessment
Time frame: Baseline, after 12 weeks
Neuropsychiatric Inventory Questionnaire
Time frame: Baseline, after 12 weeks
Cornell Scale for Depression in Dementia
Time frame: Baseline, after 12 weeks
Quality of Life in Alzheimer's
Time frame: Baseline, after 12 weeks
Katz ADL
Time frame: Baseline, after 12 weeks
Geriatric Sleep Questionnaire
Time frame: Baseline, after 12 weeks
Numbers of falls in the last 12 weeks
Time frame: Baseline, after 12 weeks
Motion Sensor GENEactiv
Time frame: Basline, after 12 weeks
Contactless Sensorbox Sleepiz
Time frame: Baseline, after 12 weeks
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 8 Oct 2024.
- Results publication: PubMed 12021425Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.
- Results publication: PubMed 1202204Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
- Results publication: PubMed 32662311Bellettiere J, Lamonte MJ, Unkart J, Liles S, Laddu-Patel D, Manson JE, Banack H, Seguin-Fowler R, Chavez P, Tinker LF, Wallace RB, LaCroix AZ. Short Physical Performance Battery and Incident Cardiovascular Events Among Older Women. J Am Heart Assoc. 2020 Jul 21;9(14):e016845. doi: 10.1161/JAHA.120.016845. Epub 2020 Jul 14.
- Results publication: PubMed 35510973Cassidy B, Arena S. The Short Physical Performance Battery as a Predictor of Functional Decline. Home Healthc Now. 2022 May-Jun 01;40(3):168-169. doi: 10.1097/NHH.0000000000001070. No abstract available.
- Results publication: PubMed 3337862Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8.
- Results publication: PubMed 9153155Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.
- Results publication: PubMed 27393566Lindbergh CA, Dishman RK, Miller LS. Functional Disability in Mild Cognitive Impairment: A Systematic Review and Meta-Analysis. Neuropsychol Rev. 2016 Jun;26(2):129-59. doi: 10.1007/s11065-016-9321-5. Epub 2016 Jul 8.
- Results publication: PubMed 28689566Sanford AM. Mild Cognitive Impairment. Clin Geriatr Med. 2017 Aug;33(3):325-337. doi: 10.1016/j.cger.2017.02.005. Epub 2017 May 17.
- Results publication: PubMed 30925610Tisher A, Salardini A. A Comprehensive Update on Treatment of Dementia. Semin Neurol. 2019 Apr;39(2):167-178. doi: 10.1055/s-0039-1683408. Epub 2019 Mar 29.
- Results publication: PubMed 20944075Erickson KI, Raji CA, Lopez OL, Becker JT, Rosano C, Newman AB, Gach HM, Thompson PM, Ho AJ, Kuller LH. Physical activity predicts gray matter volume in late adulthood: the Cardiovascular Health Study. Neurology. 2010 Oct 19;75(16):1415-22. doi: 10.1212/WNL.0b013e3181f88359. Epub 2010 Oct 13.
- Results publication: PubMed 28271072Guure CB, Ibrahim NA, Adam MB, Said SM. Impact of Physical Activity on Cognitive Decline, Dementia, and Its Subtypes: Meta-Analysis of Prospective Studies. Biomed Res Int. 2017;2017:9016924. doi: 10.1155/2017/9016924. Epub 2017 Feb 7.
- Results publication: PubMed 32085951Vancampfort D, Solmi M, Firth J, Vandenbulcke M, Stubbs B. The Impact of Pharmacologic and Nonpharmacologic Interventions to Improve Physical Health Outcomes in People With Dementia: A Meta-Review of Meta-Analyses of Randomized Controlled Trials. J Am Med Dir Assoc. 2020 Oct;21(10):1410-1414.e2. doi: 10.1016/j.jamda.2020.01.010. Epub 2020 Feb 19.
- 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.
Eling de Bruin, Prof. Dr. principal investigator
Eastern Swiss University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergaming on Dividat Senso in people with Major Neurocognitive Disorder and Alzheimer Disease, run by Eastern Switzerland University of Applied Sciences 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 8 Oct 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 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?
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 Eling de Bruin, Prof. Dr. (+41 58 257 14 11, eling.debruin@ost.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (time frame: Baseline). The study lists 2 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 NCT06631742, which also lists 14 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 8 Oct 2024.