NCT06631742

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Sep 2024Apr 2027

First Submitted

Initial submission to the registry

September 10, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

September 27, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

2.3 years

First QC Date

September 10, 2024

Last Update Submit

October 7, 2024

Conditions

Major Neurocognitive DisorderAlzheimer DiseaseParkinson DiseaseLewy Body DementiaMixed Dementias

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    after 12 weeks

Secondary Outcomes (9)

  • Montreal Cognitive Assessment

    Baseline, after 12 weeks

  • Neuropsychiatric Inventory Questionnaire

    Baseline, after 12 weeks

  • Cornell Scale for Depression in Dementia

    Baseline, after 12 weeks

  • Quality of Life in Alzheimer's

    Baseline, after 12 weeks

  • Katz ADL

    Baseline, after 12 weeks

  • +4 more secondary outcomes

Study Arms (2)

Exergaming

EXPERIMENTAL

Individual active dance game training on Dividat Senso

Other: Exergaming on Dividat Senso

Usual Care

OTHER

Customised care and support as required

Other: Usual Care

Interventions

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.

Exergaming
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.

Usual Care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sonnweid AG

Wetzikon, Canton of Zurich, 8620, Switzerland

RECRUITING

Related Publications (14)

  • 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.

    PMID: 12021425RESULT

  • Folstein 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.

    PMID: 1202204RESULT

  • Bellettiere 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.

    PMID: 32662311RESULT

  • Cassidy 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.

    PMID: 35510973RESULT

  • Alexopoulos 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.

    PMID: 3337862RESULT

  • Cummings 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.

    PMID: 9153155RESULT

  • Lindbergh 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.

    PMID: 27393566RESULT

  • Sanford 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.

    PMID: 28689566RESULT

  • Tisher 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.

    PMID: 30925610RESULT

  • Erickson 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.

    PMID: 20944075RESULT

  • Guure 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.

    PMID: 28271072RESULT

  • Vancampfort 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.

    PMID: 32085951RESULT

  • Ahlskog 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.

    PMID: 21878600RESULT

  • Dimitrov DM, Rumrill PD Jr. Pretest-posttest designs and measurement of change. Work. 2003;20(2):159-65.

    PMID: 12671209RESULT

MeSH Terms

Conditions

Alzheimer DiseaseParkinson DiseaseLewy Body DiseaseMixed Dementias

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathies

Study Officials

  • Eling de Bruin, Prof. Dr.

    Eastern Swiss University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eling de Bruin, Prof. Dr.

CONTACT

+41 58 257 14 11eling.debruin@ost.ch

Andrea Hausheer

CONTACT

+41 58 257 14 77andrea.hausheer@ost.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Eling de Bruin

Study Record Dates

First Submitted

September 10, 2024

First Posted

October 8, 2024

Study Start

September 27, 2024

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)