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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise therapy
Follow-up care as usual
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia focused on measuring Exercise therapy, Cardiovascular disease, Risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise therapy

Follow-up care as usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in peak oxygen uptake.
Peak oxygen uptake after the training period subtracted Peak oxygen uptake at baseline.

Secondary Outcome Measures

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

Full Information

First Posted
January 19, 2016
Last Updated
October 1, 2019
Sponsor
St. Olavs Hospital
Collaborators
Trondheim Kommune, Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02743143
Brief Title
Long-Term Exercise Training Therapy Versus Usual Care in Patients With Schizophrenia
Acronym
LEXUS
Official Title
Effectiveness of 1 Year Supervised Exercise Training Versus Usual Care on Cardiovascular Health, Functional Skills and Physical Fitness in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Trondheim Kommune, Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Exercise therapy, Cardiovascular disease, Risk

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Morken, PhD
Organizational Affiliation
St. Olavs University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
St. Olavs University Hospital, Division of Psychiatry, Department of Østmarka
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31565796
Citation
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.
Results Reference
result

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

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