Hjernegym - Effects of Exergaming in Psychosis: a Clinical Intervention Study

Cognitive Impairment Clinical Trial

Official title:

Hjernegym - Effects of Exergaming in Psychosis: a Clinical Intervention Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05858255
• Other study ID #: SykehusetIV
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2023
• Source: Sykehuset i Vestfold HF
• Contact: Tom Langerud Holmen, PhD
• Phone: 97119323
• Email: lantom[@]siv.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical intervention study is to investigate the effects of exergaming on cognition and other clinical symptoms in outpatient individuals with schizophrenia.

The main questions it aims to answer are: Will an exergaming intervention contribute to improved cognition and reduced clinical symptoms, as well as enhanced physical health/self-efficacy/quality of life, in individuals with schizophrenia? Will the gaming component strengthen motivation for a physically more intensive component, so that attendance will be at least as high as in comparable exercise studies despite the current study being implemented in a resource-limited, regular clinical outpatient setting? Participants will be asked to engage in two 45 minutes exergaming sessions with a designated personal trainer for 12 weeks. Results pre- and post intervention will be compared, and comparisons will also be made with a former randomized controlled trial conducted at the same site, in which the currently combined activities were investigated separately (high-intensity interval training and low-intensity video gaming), both yielding positive but different effects.

Description:

Cognitive impairment is a core clinical feature in schizophrenia, central to the affected individuals' daily functioning. Regular treatment components such as medication or psychotherapy provide no effective remediation for this. However, research has shown that both high-intensity interval training (HIIT) and active video gaming (AVG) may have beneficial effects on cognitive functioning, and also other clinical symptoms, for individuals with schizophrenia. Moreover, the two activity types yield partly overlapping, partly differentiated effects on these outcome measures: While the former may improve cognitive functions through enhanced cardio-respiratory fitness, the latter may facilitate synapto-genesis through learning of new motor- and coordination patterns. Furthermore, HIIT may counter depressive symptoms while AVG may strengthen motivation for regular activity. Results consistent with this was found in the randomized controlled trial "Effects of Physical Activity on Psychosis" (EPHAPS) previously conducted at the same site as the currently planned study (DPS Vestfold, the psychosis outpatient clinic, 2014 - 2017). Hence, the two activity types combined - "exergaming" - may have complementary positive effects on cognition and other clinical symptoms, as well as physical health, while also facilitating the participants' motivation for regular attendance. This assumption is supported by the few existing studies on exergaming interventions for individuals with schizophrenia. However, research into this area is yet scarce. Based on the existing evidence for the two activity types both separately and combined, exergaming alternatives are already being tested out in the clinic at DPS Vestfold. To meet the need for more research in this area, the investigators plan to include 48 participants in an exergaming clinical intervention study. By implementing such a study in a regular clinical setting and with the least amount of additional resources possible, the investigators also seek to demonstrate the intervention's feasibility for individuals with schizophrenia. Upon supported research hypotheses, the intervention could easily be adapted to similar clinical settings and included as a standard care-component.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Having consent capability

• Understanding and speaking Scandinavian language

• Fulfilling the International Classification of Diseases Tenth Revision (ICD 10) criteria for schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder and schizophreniform disorder)

Exclusion Criteria:

• Diagnosis of intellectual disability

• Diagnosis of neurological disorder

• History of severe head trauma

• Pregnancy

• Chest pain during exercise

• Unstable angina pectoris

• Malignant hypertension

• Uncontrollable arrhythmia

• Recent myocardial infarction

• Acute infection with lymphadenopathy

• Other specified medical condition incompatible with participation

Related Conditions & MeSH terms

• Cognitive Impairment
• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia; Psychosis

Intervention

Behavioral:
• Exergaming
Please see Arms description.

Locations

Country	Name	City	State
Norway	DPS Vestfold, Vestfold Sykehus HF	Tønsberg	Vestfold

Sponsors (1)

Lead Sponsor	Collaborator
Sykehuset i Vestfold HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improved self-efficacy as measured by the GSE.	Increased levels of self-efficacy as indicated by higher scores on the Generally Perceived Self-Efficacy Scale.	Baseline and 12 weeks.
Other	Improved quality of life as measured by the SF-12 questionnaire.	Increased experienced quality of life as indicated by higher scores on the RAND 12 Short Form Survey.	Baseline and 12 weeks.
Primary	Improved cognition as measured by increased scores on the MCCB test battery.	Cognitive improvement as measured by increased scores on the Matrics Consensus Cognitive Battery (MCCB) (except for the omitted MSCEIT social cognition test); changes in scores of each of the nine subtests as well as the total (neurocognitive composite-) score will be evaluated.	Baseline and 12 weeks.
Primary	Sustained motivation for the intervention activity (exergaming) as measured by high attendance/adherence to protocol and low levels of drop-out/withdrawal, respectively.	High attendance/adherence to protocol and low dropout/withdrawal as evaluated against a comparable exercise study conducted at the same site (dropout/withdrawal rate equal to or below 15%), with the current study being implemented in a resource-limited, regular clinical setting. These may serve as indicators of the gaming component's motivating potential for the more physically demanding elements in the intervention activity, and also the feasibility and economical viability of the activity as a regular treatment component for individuals with schizophrenia spectrum disorders.	12 weeks.
Secondary	Reduced depressive- and other symptoms as measured by the PANSS interview.	Reduction in symptom scores on the Positive and Negative Syndrome Scale; changes in scores on each of the five symptom domains of the widely used PANSS five factor consensus model suggested by Wallwork et al., as well as the total PANSS score, will be evaluated.	Baseline and 12 weeks.
Secondary	Reduced levels of self-disorders as measured by the EASE interview.	Reduction in levels of self-disorders as measured by reduced total score on the Examination of Anomalous Self-Experience interview (contingent on proper certification of the assessor/PI, for the use of the interview).	Baseline and 12 weeks.
Secondary	Improved oxygen consumption as measured by a VO2peak-test.	Increased oxygen consumption as indicated by higher scores on a VO2peak-test (a maximum exercise test on a treadmill utilizing a modified Balke protocol): Gas exchange sampled continuously (mixing chamber every 30 s); two-ways breathing valve connected to a gas analyser measuring oxygen - carbon dioxide content.	Baseline and 12 weeks.