Effects of Physical Activity in Psychosis

NCT02205684 | Unknown

• 1 other identifier: 2014/372/REK sør-øst C
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia; Substance Use

Keywords

Physical activity; Exercise; High intensity training; Schizophrenia; Symptoms; Well-being; Cognition; Hippocampal volume; Neuroplasticity; Smoking; Substance use; Metabolic indices

Outcome Measures

Primary Outcomes (1)

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

  Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment

Secondary Outcomes (3)

• Change from Baseline in Symptom load after 12 Weeks and 28 Weeks

  Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment

• Change from Baseline in Peak oxygen uptake after 12 Weeks and 28 Weeks

  Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment

• Change from Baseline in Metabolic Indices after 12 Weeks and 28 Weeks

  Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment

Study Arms (2)

Physical activity

EXPERIMENTAL

Aerobic High Intensity Training (HIT)

Other: Physical activity

Computer game skills training

ACTIVE COMPARATOR

Playing Nintendo Wii Sports

Other: Computer game skills training

Interventions

Computer game skills training OTHER

Playing Nintendo Wii Sports

Computer game skills training

Physical activity OTHER

Aerobic High Intensity Training (HIT)

Physical activity

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sykehuset i Vestfold HF: lead
• Stiftelsen Helse og Rehabilitering: collaborator
• Norwegian Research network in Severe Mental Illness: collaborator

Related Publications (8)

• 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.

  PMID: 36003983 DERIVED

• 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.

  PMID: 33539561 DERIVED

• 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.

  PMID: 33156372 DERIVED

• 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.

  PMID: 32854688 DERIVED

• 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.

  PMID: 31708824 DERIVED

• 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.

  PMID: 30528313 DERIVED

• 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.

  PMID: 28709774 DERIVED

• 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.

  PMID: 26646670 DERIVED

MeSH Terms

Conditions

Schizophrenia; Substance-Related Disorders; Motor Activity; Smoking

Interventions

Exercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Chemically-Induced Disorders; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• John A Engh, MD, PhD

  Division of Mental Health & Addiction, Vestfold Hospital Trust, Tønsberg, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: July 31, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2019
• Last Updated: April 17, 2018

Record last verified: 2018-04