Study on the Use of Exergames to Support Older Adults With Psychosis

NCT07060742 | Recruiting DMC

• 1 other identifier: Dividat-Psychosen25
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore a new, engaging approach to support older adults with psychosis-an umbrella term that includes conditions such as schizophrenia, late-onset schizophrenia, and psychotic symptoms resulting from other medical or psychiatric conditions like dementia, delirium, mood disorders, or delusional disorder. As the aging population grows, a rising number of older adults are living with schizophrenia and related disorders, facing not only psychiatric symptoms like hallucinations and delusions but also cognitive impairments, reduced mobility, social isolation, and physical decline. These combined challenges significantly affect daily functioning and quality of life. At present, there are no psychosis treatment guidelines specifically tailored for people aged 60 and above, though general principles from younger populations can be adapted. Evidence suggests that integrating physical and cognitive rehabilitation into standard psychiatric care may enhance treatment outcomes for this age group. One promising method is the use of "exergames"-interactive video games that combine physical movement with cognitive challenges. These games typically require users to perform body movements such as stepping or shifting weight in response to visual and auditory cues, thereby training functions like attention, memory, balance, coordination, and executive function. Exergames offer a playful and stimulating alternative to conventional exercises and are often better accepted by older patients because of their engaging and motivating nature. Previous studies have shown that older adults with schizophrenia not only tolerate these games well but may also experience improvements in mood, cognitive function, and physical activity levels. However, past research has been limited by small sample sizes, lack of control groups, and short intervention periods. This current study, conducted at the Psychiatric University Hospital in Basel, Switzerland, seeks to examine the feasibility and benefits of using an exergame system called Dividat Senso in a more structured and controlled setting. After being screened for eligibility, participants will be randomly assigned to one of two groups. The intervention group will receive usual psychiatric inpatient care, extended with exergame-based motor-cognitive training using the Dividat Senso platform. This device requires full-body interaction, targeting both cognitive functions (such as attention, memory, and executive skills) and physical abilities (such as balance and coordination). The control group will also receive usual care, but instead of exergames, they will participate in traditional strength and balance exercises taken from the Otago falls prevention program. Both groups will train three times a week for four weeks, with each session lasting approximately 20 minutes-totaling 12 sessions. All participants will complete assessments before the intervention begins (T1) and again after four weeks (T2), to measure changes in physical activity, mental well-being, and cognitive performance. By using a structured program and comparing two active interventions, this study aims to generate more robust and generalizable findings on how technology-based, body-and-brain training can support the mental and physical health of older adults with psychosis. If proven feasible and effective, exergame-based rehabilitation could become a valuable and enjoyable addition to psychiatric treatment programs for elderly patients.

Conditions

Psychosis; Exergaming; Elderly

Outcome Measures

Primary Outcomes (3)

• Feasibility of the exergame-based motor-cognitive training: adherence

  The adherence protocol measures the percentage of training sessions attended by participants relative to the number of planned sessions. It reflects how consistently participants follow the prescribed training schedule. Adherence is calculated by dividing the attended sessions by the planned sessions and expressing the result as a percentage. High adherence rates suggest that the intervention is feasible for older psychotic inpatients.

  Throughout the 4-week intervention period.

• Feasibility of the exergame-based motor-cognitive training: attrition

  Attrition: Drop-Out Rates. This refers to the percentage of participants who discontinue or leave the study before its completion. Drop-out rates are calculated by dividing the number of participants who withdraw by the total number initially enrolled, usually expressed as a percentage. High dropout rates may indicate issues with the intervention's feasibility.

  Time Frame: Throughout the 4-week intervention period

• Feasibility of the exergame-based motor-cognitive training: safety

  Safety, measured through the reporting of adverse events, assesses the occurrence and nature of any negative or unintended effects experienced by participants during the study. These events are systematically recorded, including their type, severity, timing, and potential relation to the intervention. No adverse events indicate that the intervention is safe and feasible.

  Time Frame: Throughout the 4-week intervention period

Secondary Outcomes (10)

• Cognitive function: inhibitory control

  Throughout the 4-week intervention period

• Cognitive function: processing speed

  Time Frame: Throughout the 4-week intervention period

• Cognitive function: selective attention

  Time Frame: Throughout the 4-week intervention period

• Cognitive function: inhibitory control

  Time Frame: Throughout the 4-week intervention period

• Motor function: mobility

  Time Frame: Throughout the 4-week intervention period

Study Arms (2)

Dividat Senso (Exergame-Based Motor-Cognitive Training)

EXPERIMENTAL

Participants in this group will receive the standard psychiatric inpatient care at the Psychiatric University Hospital Basel. In addition, they will engage in technology-based motor-cognitive training using the Dividat Senso device. This system involves interactive exergames that require participants to perform body movements such as stepping and shifting weight in response to multisensory stimuli (visual, auditory, and somatosensory). The games are designed to simultaneously stimulate physical functions (balance, coordination) and cognitive functions (attention, executive function, memory). Training sessions will be conducted three times a week for four weeks, with each session lasting approximately 20 minutes, totaling 12 sessions.

Device: Dividat Senso

OTAGO Falls-Prevention Program (Traditional Strength and Balance Exercises)

ACTIVE COMPARATOR

Participants in the control group will also receive the standard psychiatric inpatient care. Additionally, they will participate in conventional physical exercises focusing on strength and balance, based on the Otago falls prevention program. These exercises are designed to improve physical stability and reduce fall risk. Like the intervention group, participants will train three times a week for four weeks, with each session lasting about 20 minutes, totaling 12 sessions.

Other: OTAGO Falls-prevention program

Interventions

Dividat Senso DEVICE

Participants in the intervention group will receive cognitive-motor training using the Dividat Senso exergame platform, which records body movements and adapts game difficulty in real time. The training targets cognitive and physical functions through interactive games involving steps and weight shifts. It follows a progressive structure, with difficulty increasing over time, and can be personalized by investigators using the Dividat Manager.

Dividat Senso (Exergame-Based Motor-Cognitive Training)

OTAGO Falls-prevention program OTHER

The OTAGO Falls Prevention Program is an evidence-based exercise program designed to reduce falls in older adults. It includes strength and balance training exercises performed at home under the guidance of a physiotherapist. The program aims to improve muscle strength, balance, and mobility, helping to prevent falls and maintain independence.

OTAGO Falls-Prevention Program (Traditional Strength and Balance Exercises)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed psychotic disorders
• Able to provide a signed informed consent
• Age ≥ 55 years
• MoCA ≥ 20
• Physically able to stand for at least 3 minutes without external support (self-report)

You may not qualify if:

• Insufficient knowledge of the German language to understand the instructions, the games, and the assessments
• Mobility, cognitive, sensory and/or psychiatric limitations or comorbidities that impair the ability to play the exergames and/or conduct the pre-/post assessments

Sponsors & Collaborators

• Tobias Melcher: lead

Study Sites (1)

Universitäre Psychiatrischen Kliniken (UPK) Basel

Basel, Canton of Basel-City, 4002, Switzerland

RECRUITING

Related Publications (7)

• Yen HY, Chiu HL. Virtual Reality Exergames for Improving Older Adults' Cognition and Depression: A Systematic Review and Meta-Analysis of Randomized Control Trials. J Am Med Dir Assoc. 2021 May;22(5):995-1002. doi: 10.1016/j.jamda.2021.03.009. Epub 2021 Apr 2.

  PMID: 33812843 BACKGROUND

• Maillot P, Perrot A, Hartley A. Effects of interactive physical-activity video-game training on physical and cognitive function in older adults. Psychol Aging. 2012 Sep;27(3):589-600. doi: 10.1037/a0026268. Epub 2011 Nov 28.

  PMID: 22122605 BACKGROUND

• Leutwyler H, Hubbard EM, Jeste DV, Vinogradov S. "We're not just sitting on the periphery": a staff perspective of physical activity in older adults with schizophrenia. Gerontologist. 2013 Jun;53(3):474-83. doi: 10.1093/geront/gns092. Epub 2012 Aug 30.

  PMID: 22936534 BACKGROUND

• Leutwyler H, Hubbard EM, Jeste DV, Miller B, Vinogradov S. Associations of schizophrenia symptoms and neurocognition with physical activity in older adults with schizophrenia. Biol Res Nurs. 2014 Jan;16(1):23-30. doi: 10.1177/1099800413500845. Epub 2013 Sep 19.

  PMID: 24057223 BACKGROUND

• Leutwyler H, Hubbard EM, Dowling GA. Adherence to a Videogame-Based Physical Activity Program for Older Adults with Schizophrenia. Games Health J. 2014 Aug;3(4):227-33. doi: 10.1089/g4h.2014.0006. Epub 2014 May 28.

  PMID: 26192371 BACKGROUND

• Leutwyler H, Hubbard E, Cooper B, Dowling G. The Impact of a Videogame-Based Pilot Physical Activity Program in Older Adults with Schizophrenia on Subjectively and Objectively Measured Physical Activity. Front Psychiatry. 2015 Dec 21;6:180. doi: 10.3389/fpsyt.2015.00180. eCollection 2015.

  PMID: 26733891 BACKGROUND

• Camara J, Ferreira L, Faria AL, Vilar M, Bermudez I Badia S. Feasibility, Acceptability, and Preliminary Impact of Full-Body Interaction on Computerized Cognitive Training Based on Instrumental Activities of Daily Living: A Pilot Randomized Controlled Trial with Chronic Psychiatric Inpatients. Games Health J. 2022 Oct 11. doi: 10.1089/g4h.2021.0228. Online ahead of print.

  PMID: 36251861 BACKGROUND

Related Links

• The Dividat Senso is a scientifically validated exergame platform that combines cognitive and physical training through interactive step-based games, enhancing balance, coordination, and mental function in older adults and clinical populations.

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Tobias Melcher, Dr. Dripl.Psych.

  Universitäre Psychiatrischen Kliniken (UPK) Basel

  STUDY DIRECTOR

Central Study Contacts

Tobias Melcher, Dr. Dipl.-Psych.

CONTACT

+41 61 325 5163; tobias.melcher@upk.ch

Riccardo Bernardi, M.Sc. Science of Psychology

CONTACT

+41 61 325 5311; riccardo.bernardi@upk.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Dipl.-Psych. Tobias Melcher, Principal Investigator of the study

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: July 11, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): May 15, 2028
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

CH (1)