Schizophrenia; PsychosisNCT05858255
Hjernegym - Effects of Exergaming in Psychosis: a Clinical Intervention Study
A study testing Exergaming in people with Schizophrenia; Psychosis and Cognitive Impairment, run by Sykehuset i Vestfold HF at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia; Psychosis, Cognitive Impairment
- What is being tested?
- Exergaming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNorway
- Study dates
- 29 Mar 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Diagnosis of intellectual disability
- Diagnosis of neurological disorder
- History of severe head trauma
- Pregnancy
- Chest pain during exercise
- Unstable angina pectoris
Show all 11Show fewer
- Malignant hypertension
- Uncontrollable arrhythmia
- Recent myocardial infarction
- Acute infection with lymphadenopathy
- Other specified medical condition incompatible with participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
DPS Vestfold, Vestfold Sykehus HF
Tønsberg, Vestfold, 3120
Tom Langerud Holmen, PhD, 97119323 ext. 0047, lantom@siv.no
Ole Jakob Bredrup, MA, 97195391 ext. 0047, Ole.Jacob.Bredrup@siv.no
About this 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.
Read the 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
- Being tested
- Exergaming
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExergamingBehavioural
Also called Physical exercise
Please see Arms description.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Exergaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks.
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.
Measured: Baseline and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start29 Mar 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia; PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical intervention study
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sykehuset i Vestfold HF
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Langerud Holmen, Sykehuset i Vestfold HF
- Investigators
- Tom Langerud Holmen, PhD, Principal investigator, Sykehuset i Vestfold HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858255
- Sponsor's protocol ID
- SykehusetIV
- Status last verified
- May 2023
- First submitted
- 18 Apr 2023
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to restrictions on sensitive health data, the investigators are not able to openly share these data with other researchers outside the organization.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hjernegym - Effects of Exergaming in Psychosis: a Clinical Intervention Study
- ClinicalTrials.gov ID
- NCT05858255
- Acronym / sponsor ID
- SykehusetIV
- Conditions
- Schizophrenia; Psychosis, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sykehuset i Vestfold HFUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical intervention study
| Arm | Type | Receives |
|---|---|---|
| Exergaming | Experimental | Behavioral: ExergamingA 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- Diagnosis of intellectual disability
- Diagnosis of neurological disorder
- History of severe head trauma
- Pregnancy
- Chest pain during exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExergamingAlso: Physical exercisePlease see Arms description. | Behavioural | Exergaming |
Primary outcome
Improved cognition as measured by increased scores on the MCCB test battery.
Time frame: Baseline and 12 weeks.
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.
Sustained motivation for the intervention activity (exergaming) as measured by high attendance/adherence to protocol and low levels of drop-out/withdrawal, respectively.
Time frame: 12 weeks.
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.
3 secondary outcomes
Reduced depressive- and other symptoms as measured by the PANSS interview.
Time frame: Baseline and 12 weeks.
Reduced levels of self-disorders as measured by the EASE interview.
Time frame: Baseline and 12 weeks.
Improved oxygen consumption as measured by a VO2peak-test.
Time frame: Baseline and 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Individual participant dataSharing planned: No. Due to restrictions on sensitive health data, the investigators are not able to openly share these data with other researchers outside the organization.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tom Langerud Holmen, PhD principal investigator
Sykehuset i Vestfold HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergaming in people with Schizophrenia; Psychosis and Cognitive Impairment, run by Sykehuset i Vestfold HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tom Langerud Holmen, PhD (97119323 ext. 0047, lantom@siv.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved cognition as measured by increased scores on the MCCB test battery. (time frame: Baseline and 12 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.