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

NCT05858255 | Recruiting

• 1 other identifier: SykehusetIV
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Psychosis; Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Reduced depressive- and other symptoms as measured by the PANSS interview.

  Baseline and 12 weeks.

• Reduced levels of self-disorders as measured by the EASE interview.

  Baseline and 12 weeks.

• Improved oxygen consumption as measured by a VO2peak-test.

  Baseline and 12 weeks.

Other Outcomes (2)

• Improved self-efficacy as measured by the GSE.

  Baseline and 12 weeks.

• Improved quality of life as measured by the SF-12 questionnaire.

  Baseline and 12 weeks.

Study Arms (1)

Exergaming

EXPERIMENTAL

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

Interventions

Exergaming BEHAVIORAL

Please see Arms description.

Also known as: Physical exercise

Exergaming

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sykehuset i Vestfold HF: lead

Study Sites (1)

DPS Vestfold, Vestfold Sykehus HF

Tønsberg, Vestfold, 3120, Norway

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Cognitive Dysfunction

Interventions

Exergaming; Exercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Tom Langerud Holmen, PhD

  Sykehuset i Vestfold HF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom Langerud Holmen, PhD

CONTACT

97119323; lantom@siv.no

Ole Jakob Bredrup, MA

CONTACT

97195391; Ole.Jacob.Bredrup@siv.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking is planned. A secondary aim of the study is to indicate the feasibility of the intervention in a daily clinical setting, with a minimum of additional assessments and involved personnel as compared to treatment as usual. Hence, the intervention will be conducted by designated personnel in line with all other treatment activities in the clinic, and (regular and additional) assessments will, for study purposes, be conducted by the PI instead of the participant's designated clinical team. Assessments and intervention sessions will however be conducted in close collaboration with the participants' designated clinical teams.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist PhD

Model Details: Clinical intervention study

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 15, 2023
• Study Start: March 29, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)