Effects of Physical Activity in Psychosis (EPHAPS)

April 16, 2018 updated by: John Abel Engh, Sykehuset i Vestfold HF

Effects of Aerobic High Intensity Training on Symptoms, Cognition, Cortical Structure, Substance Use and Metabolic Indices in Patients With Schizophrenia Spectrum Disorder

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical activity
Aerobic High Intensity Training (HIT)
Other: Physical activity
Aerobic High Intensity Training (HIT)
Active Comparator: Computer game skills training
Playing Nintendo Wii Sports
Other: Computer game skills training
Playing Nintendo Wii Sports

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment
Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment
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
Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset i Vestfold HF

Collaborators

Stiftelsen Helse og Rehabilitering
Norwegian Research network in Severe Mental Illness

Investigators

  • Principal Investigator: John A Engh, MD, PhD, Division of Mental Health & Addiction, Vestfold Hospital Trust, Tønsberg, Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

October 1, 2017

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

July 29, 2014

First Submitted That Met QC Criteria

July 29, 2014

First Posted (Estimate)

July 31, 2014

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/372/REK sør-øst C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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