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

Primary Purpose

Schizophrenia; Psychosis, Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exergaming
Sponsored by
Sykehuset i Vestfold HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia; Psychosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DPS Vestfold, Vestfold Sykehus HFRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exergaming

Arm Description

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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).
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.

Full Information

First Posted
April 18, 2023
Last Updated
May 4, 2023
Sponsor
Sykehuset i Vestfold HF
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1. Study Identification

Unique Protocol Identification Number
NCT05858255
Brief Title
Hjernegym - Effects of Exergaming in Psychosis: a Clinical Intervention Study
Official Title
Hjernegym - Effects of Exergaming in Psychosis: a Clinical Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sykehuset i Vestfold HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia; Psychosis, Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Clinical intervention study
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exergaming
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Exergaming
Other Intervention Name(s)
Physical exercise
Intervention Description
Please see Arms description.
Primary Outcome Measure Information:
Title
Improved cognition as measured by increased scores on the MCCB test battery.
Description
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.
Title
Sustained motivation for the intervention activity (exergaming) as measured by high attendance/adherence to protocol and low levels of drop-out/withdrawal, respectively.
Description
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 Outcome Measure Information:
Title
Reduced depressive- and other symptoms as measured by the PANSS interview.
Description
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.
Title
Reduced levels of self-disorders as measured by the EASE interview.
Description
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.
Title
Improved oxygen consumption as measured by a VO2peak-test.
Description
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 Pre-specified Outcome Measures:
Title
Improved self-efficacy as measured by the GSE.
Description
Increased levels of self-efficacy as indicated by higher scores on the Generally Perceived Self-Efficacy Scale.
Time Frame
Baseline and 12 weeks.
Title
Improved quality of life as measured by the SF-12 questionnaire.
Description
Increased experienced quality of life as indicated by higher scores on the RAND 12 Short Form Survey.
Time Frame
Baseline and 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tom Langerud Holmen, PhD
Phone
97119323
Ext
0047
Email
lantom@siv.no
First Name & Middle Initial & Last Name or Official Title & Degree
Ole Jakob Bredrup, MA
Phone
97195391
Ext
0047
Email
Ole.Jacob.Bredrup@siv.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Langerud Holmen, PhD
Organizational Affiliation
Sykehuset i Vestfold HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
DPS Vestfold, Vestfold Sykehus HF
City
Tønsberg
State/Province
Vestfold
ZIP/Postal Code
3120
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Langerud Holmen, PhD
Phone
97119323
Ext
0047
Email
lantom@siv.no
First Name & Middle Initial & Last Name & Degree
Ole Jakob Bredrup, MA
Phone
97195391
Ext
0047
Email
Ole.Jacob.Bredrup@siv.no
First Name & Middle Initial & Last Name & Degree
Tom Langerud Holmen, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

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

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