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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Schizophrenia; Psychosis
• Intervention / Treatment: Behavioral: Exergaming

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.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tom Langerud Holmen, PhD; Phone Number: 0047 97119323; Email: lantom@siv.no
• Study Contact Backup: Name: Ole Jakob Bredrup, MA; Phone Number: 0047 97195391; Email: Ole.Jacob.Bredrup@siv.no

Study Locations

• Norway
  • Vestfold
    • Tønsberg, Vestfold, Norway, 3120
      • Recruiting
      • DPS Vestfold, Vestfold Sykehus HF
      • Contact: Tom Langerud Holmen, PhD; Phone Number: 0047 97119323; Email: lantom@siv.no
      • Contact: Ole Jakob Bredrup, MA; Phone Number: 0047 97195391; Email: Ole.Jacob.Bredrup@siv.no
      • Principal Investigator: Tom Langerud Holmen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: Exergaming; Please see Arms description.; Other Names: Physical exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Sykehuset i Vestfold HF
• Investigators: Principal Investigator: Tom Langerud Holmen, PhD, Sykehuset i Vestfold HF

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2023
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: SykehusetIV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to restrictions on sensitive health data, the investigators are not able to openly share these data with other researchers outside the organization.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No