Long-Term Exercise Training Therapy Versus Usual Care in Patients With Schizophrenia (LEXUS)

October 1, 2019 updated by: St. Olavs Hospital

Effectiveness of 1 Year Supervised Exercise Training Versus Usual Care on Cardiovascular Health, Functional Skills and Physical Fitness in Patients With Schizophrenia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • St. Olavs University Hospital, Division of Psychiatry, Department of Østmarka

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise therapy
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
Active Comparator: Follow-up care as usual
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in peak oxygen uptake.
Time Frame: Baseline, 12 weeks, 1 year, 2 years.
Peak oxygen uptake after the training period subtracted Peak oxygen uptake at baseline.
Baseline, 12 weeks, 1 year, 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in physical activity.
Time Frame: Baseline, 12 weeks, 1 year, 2 years.
Activity counts measured by Actigraph after the training period subtracted Actigraph measurements at baseline.
Baseline, 12 weeks, 1 year, 2 years.
Changes in walking economy.
Time Frame: Baseline, 12 weeks, 1 year, 2 years.
Walking economy (oxygen uptake at a standard workload) after the training period subtracted walking economy at baseline.
Baseline, 12 weeks, 1 year, 2 years.
Real world functional behavior
Time Frame: Baseline, 1 year, 2 years.
Specific levels of functioning scale (SLOF).
Baseline, 1 year, 2 years.
Functional competence
Time Frame: Baseline,1 year, 2 years.
University of California San Diego Performance-Based Skills Assessments (UPSA-Brief).
Baseline,1 year, 2 years.
Hospital stays and contact with health care providers.
Time Frame: Baseline, 1 year, 2 years.
Registrations from patient journals
Baseline, 1 year, 2 years.
Balance
Time Frame: Baseline, 12 weeks, 1 year, 2 years.
Single leg stance. Measured in seconds.
Baseline, 12 weeks, 1 year, 2 years.
Sit-to-stand test
Time Frame: Baseline, 12 weeks, 1 year, 2 years.
30-second sit-to-stand test. Number of full stands in 30 seconds.
Baseline, 12 weeks, 1 year, 2 years.
Walking performance
Time Frame: Baseline, 12 weeks, 1 year, 2 years.
6-minute walk test. Performance measured in meters.
Baseline, 12 weeks, 1 year, 2 years.
Stair performance
Time Frame: Baseline, 12 weeks, 1 year, 2 years.
Stair test. Participants are instructed to ascend and descend 18 steps 3 consecutive times. Performance measured in seconds.
Baseline, 12 weeks, 1 year, 2 years.
Clinical symptoms.
Time Frame: Baseline, 1 year, 2 years.
Positive and Negative Syndrome Scale (PANSS).
Baseline, 1 year, 2 years.
Global functioning
Time Frame: Baseline, 1 year, 2 years.
Global Assessment of Functioning Scale (GAFs and GAFf)
Baseline, 1 year, 2 years.
Quality of life.
Time Frame: Baseline, 12 weeks, 1 year, 2 years.
SF-36® Health Survey (SF-36)
Baseline, 12 weeks, 1 year, 2 years.
Quality-adjusted life year
Time Frame: Baseline, 12 weeks, 1 year, 2 years.
EuroQol five dimensions questionnaire (EQ-5D)
Baseline, 12 weeks, 1 year, 2 years.
Morning fasting blood levels.
Time Frame: Baseline, 12 weeks, 1 year, 2 years.
Baseline, 12 weeks, 1 year, 2 years.
Tobacco
Time Frame: Baseline, 12 weeks, 1 year, 2 years.
Tobacco use measured by Fagerströms.
Baseline, 12 weeks, 1 year, 2 years.
Alcohol and substance abuse
Time Frame: Baseline, 12 weeks, 1 year, 2 years.
Substance abuse are measured by the Alcohol and Drug Use Disorder Identification test (AUDIT and DUDIT).
Baseline, 12 weeks, 1 year, 2 years.
Motivation
Time Frame: Baseline, 12 weeks, 1 year, 2 years.
Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2).
Baseline, 12 weeks, 1 year, 2 years.
Readiness/confidence to change
Time Frame: Baseline, 12 weeks, 1 year, 2 years.
Rulers (0-10 scale: readiness, importance, confidence).
Baseline, 12 weeks, 1 year, 2 years.
Client Satisfaction
Time Frame: Baseline, 12 weeks, 1 year, 2 years.
Client Satisfaction Questionnaire (CSQ-8).
Baseline, 12 weeks, 1 year, 2 years.
Changes in maximal strength.
Time Frame: Baseline, 12 weeks, 1 year, 2 years.
Maximal strength (measures as 1 repetition maximum (1RM)) after the training period subtracted 1RM at baseline.
Baseline, 12 weeks, 1 year, 2 years.
Patient activation
Time Frame: Baseline, 1 week, 12 weeks, 6 months, 1 year, 2 years
Patient Activation Measure (PAM-13 GH)
Baseline, 1 week, 12 weeks, 6 months, 1 year, 2 years
Patient activation
Time Frame: Baseline, 1 week, 12 weeks, 6 months, 1 year, 2 years
Patient Activation Measure (PAM-13 MH)
Baseline, 1 week, 12 weeks, 6 months, 1 year, 2 years

Collaborators and Investigators

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

Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology
Trondheim Kommune

Investigators

  • Study Director: Gunnar Morken, PhD, St. Olavs University Hospital

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)

December 1, 2015

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Actual)

October 3, 2019

Last Update Submitted That Met QC Criteria

October 1, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/1611

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Schizophrenia

Clinical Trials on Exercise therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe