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
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
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
NCT ID
NCT02205684
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
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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