Clinical trial NCT05858255: Hjernegym - Effects of Exergaming in Psychosis: a Clinical Intervention Study
Official title: Hjernegym - Effects of Exergaming in Psychosis: a Clinical Intervention Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia; Psychosis
Cognitive Impairment
Lead sponsor: Sykehuset i Vestfold HF
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clinical intervention study
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improved cognition as measured by increased scores on the MCCB test battery.
timeFrame: Baseline and 12 weeks.
measure: Sustained motivation for the intervention activity (exergaming) as measured by high attendance/adherence to protocol and low levels of drop-out/withdrawal, respectively.
timeFrame: 12 weeks.
Secondary outcomes:
measure: Reduced depressive- and other symptoms as measured by the PANSS interview.
timeFrame: Baseline and 12 weeks.
measure: Reduced levels of self-disorders as measured by the EASE interview.
timeFrame: Baseline and 12 weeks.
measure: Improved oxygen consumption as measured by a VO2peak-test.
timeFrame: Baseline and 12 weeks.
Other outcomes:
measure: Improved self-efficacy as measured by the GSE.
timeFrame: Baseline and 12 weeks.
measure: Improved quality of life as measured by the SF-12 questionnaire.
timeFrame: Baseline and 12 weeks.
Locations:
city: Tønsberg
country: Norway
facility: DPS Vestfold, Vestfold Sykehus HF
state: Vestfold
Study officials:
affiliation: Sykehuset i Vestfold HF
name: Tom Langerud Holmen, PhD
role: PRINCIPAL_INVESTIGATOR
References: