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

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ClinicalTrials.gov Identifier: NCT02743143
Recruitment Status : Active, not recruiting
First Posted : April 19, 2016
Last Update Posted : September 5, 2018
Sponsor:
Collaborators:
Trondheim Kommune
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Exercise therapy Other: Follow-up care as usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of 1 Year Supervised Exercise Training Versus Usual Care on Cardiovascular Health, Functional Skills and Physical Fitness in Patients With Schizophrenia
Actual Study Start Date : December 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743143


Locations
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Norway
St. Olavs University Hospital, Division of Psychiatry, Department of Østmarka
Trondheim, Norway
Sponsors and Collaborators
St. Olavs Hospital
Trondheim Kommune
Norwegian University of Science and Technology
Investigators
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Study Director: Gunnar Morken, PhD St. Olavs University Hospital

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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT02743143     History of Changes
Other Study ID Numbers: 2015/1611
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by St. Olavs Hospital:
Exercise therapy
Cardiovascular disease
Risk

Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders