NCT02743143

Brief Summary

Patients with schizophrenia have disabling symptoms and cognitive deficits that limit motivation, drive, social- and occupational performance, quality of life and self-efficacy. Schizophrenia also leads to a high risk of dying from cardiovascular disease. Explanatory trials suggest that exercise improves cognitive functioning, symptoms, and quality of life, and reduces the risk of cardiovascular disease. However, due to this illness, the participation in regular exercise is challenging. In this study it will be tested if patients with schizophrenia can participate in long-term exercise therapy, and whether long-term supervised exercise therapy is more beneficial than today's usual care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

2.5 years

First QC Date

January 19, 2016

Last Update Submit

October 1, 2019

Conditions

Schizophrenia

Keywords

Exercise therapyCardiovascular diseaseRisk

Outcome Measures

Primary Outcomes (1)

  • Change in peak oxygen uptake.

    Peak oxygen uptake after the training period subtracted Peak oxygen uptake at baseline.

    Baseline, 12 weeks, 1 year, 2 years.

Secondary Outcomes (22)

  • Change in physical activity.

    Baseline, 12 weeks, 1 year, 2 years.

  • Changes in walking economy.

    Baseline, 12 weeks, 1 year, 2 years.

  • Real world functional behavior

    Baseline, 1 year, 2 years.

  • Functional competence

    Baseline,1 year, 2 years.

  • Hospital stays and contact with health care providers.

    Baseline, 1 year, 2 years.

  • +17 more secondary outcomes

Study Arms (2)

Exercise therapy

EXPERIMENTAL

High aerobic intensity training and maximal strength training 2 times per week in 1 year at the Hospital's Exercise Training Clinic. Patients receive comprehensive support from Trondheim municipal administration to facilitate adherence.

Behavioral: Exercise therapy

Follow-up care as usual

ACTIVE COMPARATOR

The usual care (UC) group will receive the usual physical activity offered by the primary health care system. UC includes the traditional physical activity advice from the Health Directorate. The UC group are invited to supervised exercise at the exercise training Clinic after 1 year.

Other: Follow-up care as usual

Interventions

Exercise therapyBEHAVIORAL
Exercise therapy
Follow-up care as usualOTHER
Follow-up care as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • International Classification of Diseases (ICD-10) schizophrenia, schizotypal or delusional disorders (F20 to F29)
  • able to carry out long-term exercise.
  • capable of giving informed consent.

You may not qualify if:

  • contra-indication for exercise training and testing according to the American College of Sports Medicine (ACSM) specifications (life threatening or terminal medical conditions; not able to carry out intervention or test procedures; current pregnancy; mothers less than 6 months post-partum).
  • patients under admittance to an acute psychiatric ward.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs University Hospital, Division of Psychiatry, Department of Østmarka

Trondheim, Norway

Location

Related Publications (1)

  • Brobakken MF, Nygard M, Guzey IC, Morken G, Reitan SK, Heggelund J, Wang E, Vedul-Kjelsaas E. Aerobic interval training in standard treatment of out-patients with schizophrenia: a randomized controlled trial. Acta Psychiatr Scand. 2019 Dec;140(6):498-507. doi: 10.1111/acps.13105. Epub 2019 Oct 16.

    PMID: 31565796RESULT

MeSH Terms

Conditions

SchizophreniaCardiovascular Diseases

Interventions

Exercise TherapyAftercare

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesHealth ServicesHealth Care Facilities Workforce and ServicesPrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Gunnar Morken, PhD

    St. Olavs University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2016

First Posted

April 19, 2016

Study Start

December 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

October 3, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)