Intervention Study of an Individualized Exergame Training for People With Major Neurocognitive Disorder

NCT ID: NCT04436315

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2021-12-30

Brief Summary

This study evaluates the feasibility of the intervention and the study design.

Detailed Description

This study evaluates the feasibility of the intervention and the study design. Furthermore, it investigates the effects of an exergame training including strength, balance, cognitive and pelvic floor muscle training. The main risk in this study is related to potential accidents/falls during the training (and not mainly to the data acquisition procedures). But as the difficulty of the training game is adaptive, the participants will always be challenged on an appropriate level for their physical condition. Furthermore, before and after the training period, several low risk measurements are conducted. This study contributes to fundamental research investigating how multicomponent exergame training influence physical and cognitive functions.

Conditions

Exergame; Major Neurocognitive Disorder; Long-term Care Facility; Nursing Home

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

Exergame intervention

Group Type: EXPERIMENTAL

Motor-cognitive training device

Intervention Type: DEVICE

Motor-cognitive training device

Control

Active control condition

Group Type: SHAM_COMPARATOR

Active control condition

Intervention Type: OTHER

Physical activity program

Interventions

Motor-cognitive training device

Motor-cognitive training device

Intervention Type: DEVICE

Active control condition

Physical activity program

Intervention Type: OTHER

Other Intervention Names

Vitaal exergame; Physical therapy program

Eligibility Criteria

Inclusion Criteria

• Aged 60+ years
• Living in residency "de Wingerd" in Leuven (at least two weeks here)
• Being able to straight for minimal 10 minutes without aids
• Visual acuity with correction sufficient to see on a TV screen
• diagnosed with major neurocognitive disorder

Exclusion Criteria

• Mobility impairments that don't allow to play the exergame
• Any unstable cardiovascular or other health condition which according to the American College of Sports Medicine Standards might lead to unsafe participation (e.g. recent cardiac infarction, uncontrolled diabetes or hypertension)
• Orthopaedic or neurological diseases that prevent exergame training
• Rapidly progressive or terminal illness

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Davy Vancampfort

OTHER

Sponsor Role: lead

Responsible Party

Davy Vancampfort

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

De Wingerd

Leuven, Vlaams Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Nathalie Swinnen

Role: CONTACT

nathalie.swinnen@kuleuven.be

+3216348215

Davy Vancampfort

Role: CONTACT

davy.vancampfort@kuleuven.be

+3216376564

Facility Contacts

Nathalie Swinnen

Role: primary

nathalie.swinnen@kuleuven.be

+3216348215

References

Swinnen N, de Bruin ED, Guimaraes V, Dumoulin C, De Jong J, Akkerman R, Vandenbulcke M, Stubbs B, Vancampfort D. The feasibility of a stepping exergame prototype for older adults with major neurocognitive disorder residing in a long-term care facility: a mixed methods pilot study. Disabil Rehabil. 2023 Feb 23:1-15. doi: 10.1080/09638288.2023.2182916. Online ahead of print.

Reference Type: DERIVED

PMID: 36824039 (View on PubMed)

Other Identifiers

082020

Identifier Type: -

Identifier Source: org_study_id