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Effects of Physical Activity in Psychosis (EPHAPS)

Primary Purpose

Schizophrenia, Substance Use

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Computer game skills training
Physical activity
Sponsored by
Sykehuset i Vestfold HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Physical activity, Exercise, High intensity training, Schizophrenia, Symptoms, Well-being, Cognition, Hippocampal volume, Neuroplasticity, Smoking, Substance use, Metabolic indices

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • verified (Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, SCID) diagnosis of schizophrenia spectrum disorder
  • outpatient in treatment
  • written informed consent
  • fluent in a Scandinavian language

Exclusion Criteria:

  • chest pain during exercise
  • unstable angina pectoris
  • suspicion of recent myocardial infarction
  • uncontrollable arrhythmia
  • acute infection with lymphadenopathy
  • malignant hypertension
  • neurological disorder
  • severe physical disability
  • medical condition incompatible with particiption
  • comorbid diagnosis of mild mental retardation
  • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Physical activity

    Computer game skills training

    Arm Description

    Aerobic High Intensity Training (HIT)

    Playing Nintendo Wii Sports

    Outcomes

    Primary Outcome Measures

    Change from Baseline in Cognitive Function after 12 Weeks and 28 Weeks

    Secondary Outcome Measures

    Change from Baseline in Symptom load after 12 Weeks and 28 Weeks
    Change from Baseline in Peak oxygen uptake after 12 Weeks and 28 Weeks
    Change from Baseline in Metabolic Indices after 12 Weeks and 28 Weeks

    Full Information

    First Posted
    July 29, 2014
    Last Updated
    April 16, 2018
    Sponsor
    Sykehuset i Vestfold HF
    Collaborators
    Stiftelsen Helse og Rehabilitering, Norwegian Research network in Severe Mental Illness
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02205684
    Brief Title
    Effects of Physical Activity in Psychosis
    Acronym
    EPHAPS
    Official Title
    Effects of Aerobic High Intensity Training on Symptoms, Cognition, Cortical Structure, Substance Use and Metabolic Indices in Patients With Schizophrenia Spectrum Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2014 (Actual)
    Primary Completion Date
    October 2017 (Actual)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sykehuset i Vestfold HF
    Collaborators
    Stiftelsen Helse og Rehabilitering, Norwegian Research network in Severe Mental Illness

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Physical health problems are common in schizophrenia with a two- to three-fold increased morbidity and mortality rate, resulting in a 20 years reduction in life expectancy. A genetic vulnerability for developing cardiovascular disease has been documented in these patients, and many lifestyle factors also negatively influence physical health. Patients with schizophrenia are likely to smoke, are physically inactive and overweight, suffer from malnutrition due to unhealthy diet, and have reduced cardiorespiratory fitness. Moreover, these patients have increased risk of developing diabetes mellitus type II and metabolic syndrome. These aspects demonstrate the need for multi-disciplinary treatments of patients with schizophrenia and underline the need for addressing their physical health. Poor physical fitness seems to be associated with exacerbated negative symptoms and increased cognitive dysfunction in patients with schizophrenia. However, evidence on physical activity and its consequences in schizophrenia is scarce. In this randomized controlled trial we investigate the effects of high intensity training in outpatients with schizophrenia on psychotic symptoms and well-being, cognition and cortical structure, tobacco smoking and substance use, in addition to metabolic indices.
    Detailed Description
    Outpatients in treatment will be recruited in this randomized controlled trial (RCT). The patients will be randomized to either a Computer gaming Skills Group (CSG) or to a physical Exercise Group (EG). The groups are identically organized in two locations. The interventions last for 12 weeks, and treatment as usual will be continued for all patients. Patients will be assessed when entering the study (after randomization and allocation to one of the clinical groups), as well as post-treatment and 4 months post-treatment. Thus, the planned study is prospective with a longitudinal design. It is single blind in the sense that the assessment of psychiatric symptom level and neurocognitive function will be performed by research staff blind for group membership. The physiological testing will be performed by staff involved in training and will not be blinded. EG participants will perform aerobic high intensity training (HIT) consisting of supervised walking/running on a treadmill 2 times a week for 12 weeks. Each session will have the following structure; eight-minute warm-up, followed by four times four minutes intervals with 85-95% of maximum heart rate, with active pauses of three minutes of walking at 70% of maximum heart rate. The exercise session will end with a five minute cool-down period. HIT performed as 4 x 4 intervals has been proven feasible and safe among patients with schizophrenia and in other clinical populations. Participants in the CSG take part in sessions in the clinic playing computer games (Nintendo Wii Sports). The time spent with activities in the clinic will be the same in both groups. When absent from scheduled physical exercise/playing computer games the subjects will be offered to participate on a following day. If absent for a whole week, the training period/computer games playing period will be prolonged accordingly. In this randomized controlled trial we investigate the effects of HIT in outpatients with schizophrenia on symptoms and well-being, cognition and brain structure, smoking habits and substance use, as well as metabolic indices. The participating outpatient clinics are catchment area based and cover a population of 200 000 persons with more than 250 patients in the diagnostic group in treatment at one time.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Substance Use
    Keywords
    Physical activity, Exercise, High intensity training, Schizophrenia, Symptoms, Well-being, Cognition, Hippocampal volume, Neuroplasticity, Smoking, Substance use, Metabolic indices

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    126 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Physical activity
    Arm Type
    Experimental
    Arm Description
    Aerobic High Intensity Training (HIT)
    Arm Title
    Computer game skills training
    Arm Type
    Active Comparator
    Arm Description
    Playing Nintendo Wii Sports
    Intervention Type
    Other
    Intervention Name(s)
    Computer game skills training
    Intervention Description
    Playing Nintendo Wii Sports
    Intervention Type
    Other
    Intervention Name(s)
    Physical activity
    Intervention Description
    Aerobic High Intensity Training (HIT)
    Primary Outcome Measure Information:
    Title
    Change from Baseline in Cognitive Function after 12 Weeks and 28 Weeks
    Time Frame
    Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment
    Secondary Outcome Measure Information:
    Title
    Change from Baseline in Symptom load after 12 Weeks and 28 Weeks
    Time Frame
    Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment
    Title
    Change from Baseline in Peak oxygen uptake after 12 Weeks and 28 Weeks
    Time Frame
    Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment
    Title
    Change from Baseline in Metabolic Indices after 12 Weeks and 28 Weeks
    Time Frame
    Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    67 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: verified (Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, SCID) diagnosis of schizophrenia spectrum disorder outpatient in treatment written informed consent fluent in a Scandinavian language Exclusion Criteria: chest pain during exercise unstable angina pectoris suspicion of recent myocardial infarction uncontrollable arrhythmia acute infection with lymphadenopathy malignant hypertension neurological disorder severe physical disability medical condition incompatible with particiption comorbid diagnosis of mild mental retardation pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John A Engh, MD, PhD
    Organizational Affiliation
    Division of Mental Health & Addiction, Vestfold Hospital Trust, Tønsberg, Norway
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    36003983
    Citation
    Bang-Kittilsen G, Engh JA, Holst R, Holmen TL, Bigseth TT, Andersen E, Mordal J, Egeland J. High-intensity interval training may reduce depressive symptoms in individuals with schizophrenia, putatively through improved VO2max: A randomized controlled trial. Front Psychiatry. 2022 Aug 4;13:921689. doi: 10.3389/fpsyt.2022.921689. eCollection 2022.
    Results Reference
    derived
    PubMed Identifier
    33539561
    Citation
    Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.
    Results Reference
    derived
    PubMed Identifier
    33156372
    Citation
    Bang-Kittilsen G, Egeland J, Holmen TL, Bigseth TT, Andersen E, Mordal J, Ulleberg P, Engh JA. High-intensity interval training and active video gaming improve neurocognition in schizophrenia: a randomized controlled trial. Eur Arch Psychiatry Clin Neurosci. 2021 Mar;271(2):339-353. doi: 10.1007/s00406-020-01200-4. Epub 2020 Nov 6.
    Results Reference
    derived
    PubMed Identifier
    32854688
    Citation
    Andersen E, Bang-Kittilsen G, Bigseth TT, Egeland J, Holmen TL, Martinsen EW, Stensrud T, Engh JA. Effect of high-intensity interval training on cardiorespiratory fitness, physical activity and body composition in people with schizophrenia: a randomized controlled trial. BMC Psychiatry. 2020 Aug 27;20(1):425. doi: 10.1186/s12888-020-02827-2.
    Results Reference
    derived
    PubMed Identifier
    31708824
    Citation
    Holmen TL, Egeland J, Andersen E, Mordal J, Andreassen OA, Ueland T, Bigseth TT, Bang-Kittilsen G, Engh JA. The Association Between Cardiorespiratory Fitness and Cognition Appears Neither Related to Current Physical Activity Nor Mediated by Brain-Derived Neurotrophic Factor in a Sample of Outpatients With Schizophrenia. Front Psychiatry. 2019 Oct 25;10:785. doi: 10.3389/fpsyt.2019.00785. eCollection 2019.
    Results Reference
    derived
    PubMed Identifier
    30528313
    Citation
    Holmen TL, Engh JA, Andersen E, Andreassen OA, Martinsen EW, Bigseth TT, Bang-Kittilsen G, Egeland J. Cardio-respiratory fitness is associated with a verbal factor across cognitive domains in schizophrenia. Schizophr Res. 2019 Apr;206:157-162. doi: 10.1016/j.schres.2018.11.033. Epub 2018 Dec 7.
    Results Reference
    derived
    PubMed Identifier
    28709774
    Citation
    Holmen TL, Egeland J, Andersen E, Bigseth TT, Engh JA. The association between cardio-respiratory fitness and cognition in schizophrenia. Schizophr Res. 2018 Mar;193:418-422. doi: 10.1016/j.schres.2017.07.015. Epub 2017 Jul 11.
    Results Reference
    derived
    PubMed Identifier
    26646670
    Citation
    Engh JA, Andersen E, Holmen TL, Martinsen EW, Mordal J, Morken G, Egeland J. Effects of high-intensity aerobic exercise on psychotic symptoms and neurocognition in outpatients with schizophrenia: study protocol for a randomized controlled trial. Trials. 2015 Dec 8;16:557. doi: 10.1186/s13063-015-1094-2.
    Results Reference
    derived

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    Effects of Physical Activity in Psychosis

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