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

NCT ID: NCT05858255

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-29
• Study Completion Date: 2026-12-31

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.

Conditions

Schizophrenia; Psychosis; Cognitive Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exergaming

A 12-weeks, twice a week exergaming program, consisting of a combined high-intensity interval training and flash-reflex pods gaming condition, each session lasting 45 minutes, conducted one-on-one with a designated personal trainer (experienced and authorized health personnel with additional competence in exercise/sports and/or physical therapy).

Group Type: EXPERIMENTAL

Exergaming

Intervention Type: BEHAVIORAL

Please see Arms description.

Interventions

Exergaming

Please see Arms description.

Intervention Type: BEHAVIORAL

Other Intervention Names

Physical exercise

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sykehuset i Vestfold HF

OTHER

Sponsor Role: lead

Responsible Party

Tom Langerud Holmen

Clinical Psychologist PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tom Langerud Holmen, PhD

Role: PRINCIPAL_INVESTIGATOR

Sykehuset i Vestfold HF

Locations

DPS Vestfold, Vestfold Sykehus HF

Tønsberg, Vestfold, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Tom Langerud Holmen, PhD

Role: CONTACT

lantom@siv.no

97119323 ext. 0047

Ole Jakob Bredrup, MA

Role: CONTACT

Ole.Jacob.Bredrup@siv.no

97195391 ext. 0047

Facility Contacts

Tom Langerud Holmen, PhD

Role: primary

lantom@siv.no

97119323 ext. 0047

Ole Jakob Bredrup, MA

Role: backup

Ole.Jacob.Bredrup@siv.no

97195391 ext. 0047

Other Identifiers

SykehusetIV

Identifier Type: -

Identifier Source: org_study_id