Hjernegym - Effects of Exergaming in Psychosis: a Clinical Intervention Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSykehuset i Vestfold HF
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Diagnosis of intellectual disability
Diagnosis of neurological disorder
History of severe head trauma
Pregnancy
Trial design
Design model
Single group
Treatments tested in this trial
Exergaming
BehavioralPlease see Arms description.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: ExergamingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 12 weeks.2
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.
Time frame
12 weeks.Secondary outcomes
1
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.
Time frame
Baseline and 12 weeks.2
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).
Time frame
Baseline and 12 weeks.3
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.
Time frame
Baseline and 12 weeks.Other outcomes
1
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.
Time frame
Baseline and 12 weeks.2
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.
Time frame
Baseline and 12 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov