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Effects of Physical Activity in Psychosis (EPHAPS)

16. april 2018 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

126

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 67 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Physical activity
Aerobic High Intensity Training (HIT)
Annen: Physical activity
Aerobic High Intensity Training (HIT)
Aktiv komparator: Computer game skills training
Playing Nintendo Wii Sports
Annen: Computer game skills training
Playing Nintendo Wii Sports

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change from Baseline in Cognitive Function after 12 Weeks and 28 Weeks
Tidsramme: Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment
Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment

Sekundære resultatmål

Resultatmål
Tidsramme
Change from Baseline in Symptom load after 12 Weeks and 28 Weeks
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment
Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sykehuset i Vestfold HF

Samarbeidspartnere

Stiftelsen Helse og Rehabilitering
Norwegian Research network in Severe Mental Illness

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2014

Primær fullføring (Faktiske)

1. oktober 2017

Studiet fullført (Forventet)

1. desember 2019

Datoer for studieregistrering

Først innsendt

29. juli 2014

Først innsendt som oppfylte QC-kriteriene

29. juli 2014

Først lagt ut (Anslag)

31. juli 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. april 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. april 2018

Sist bekreftet

1. april 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2014/372/REK sør-øst C

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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