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Completed

NCT Number: NCT02743143

Long-Term Exercise Training Therapy Versus Usual Care 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.

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Key information

Conditions

Schizophrenia Cardiovascular Diseases Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise Therapy

Behavioral

Follow-up care as usual

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Real world functional behavior

    Time frame: Baseline, 1 year, 2 years.

    Specific levels of functioning scale (SLOF).

  4. Functional competence

    Time frame: Baseline,1 year, 2 years.

    University of California San Diego Performance-Based Skills Assessments (UPSA-Brief).

  5. Hospital stays and contact with health care providers.

    Time frame: Baseline, 1 year, 2 years.

    Registrations from patient journals

  6. Balance

    Time frame: Baseline, 12 weeks, 1 year, 2 years.

    Single leg stance. Measured in seconds.

  7. 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.

  8. Walking performance

    Time frame: Baseline, 12 weeks, 1 year, 2 years.

    6-minute walk test. Performance measured in meters.

  9. 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.

  10. Clinical symptoms.

    Time frame: Baseline, 1 year, 2 years.

    Positive and Negative Syndrome Scale (PANSS).

  11. Global functioning

    Time frame: Baseline, 1 year, 2 years.

    Global Assessment of Functioning Scale (GAFs and GAFf)

  12. Quality of life.

    Time frame: Baseline, 12 weeks, 1 year, 2 years.

    SF-36® Health Survey (SF-36)

  13. Quality-adjusted life year

    Time frame: Baseline, 12 weeks, 1 year, 2 years.

    EuroQol five dimensions questionnaire (EQ-5D)

  14. Morning fasting blood levels.

    Time frame: Baseline, 12 weeks, 1 year, 2 years.

  15. Tobacco

    Time frame: Baseline, 12 weeks, 1 year, 2 years.

    Tobacco use measured by Fagerströms.

  16. 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).

  17. Motivation

    Time frame: Baseline, 12 weeks, 1 year, 2 years.

    Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2).

  18. Readiness/confidence to change

    Time frame: Baseline, 12 weeks, 1 year, 2 years.

    Rulers (0-10 scale: readiness, importance, confidence).

  19. Client Satisfaction

    Time frame: Baseline, 12 weeks, 1 year, 2 years.

    Client Satisfaction Questionnaire (CSQ-8).

  20. 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.

  21. Patient activation

    Time frame: Baseline, 1 week, 12 weeks, 6 months, 1 year, 2 years

    Patient Activation Measure (PAM-13 GH)

  22. Patient activation

    Time frame: Baseline, 1 week, 12 weeks, 6 months, 1 year, 2 years

    Patient Activation Measure (PAM-13 MH)

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology
  • Trondheim Kommune

Registry information

Official study title

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

Acronym: LEXUS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 19, 2016
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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