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

Schizophrenia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02743143
• Other study ID #: 2015/1611
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: June 2018

Study information

• Verified date: October 2019
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Exercise therapy

Other:
• Follow-up care as usual

Locations

Country	Name	City	State
Norway	St. Olavs University Hospital, Division of Psychiatry, Department of Østmarka	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology, Trondheim Kommune

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Brobakken MF, Nygård M, Güzey IC, Morken G, Reitan SK, Heggelund J, Wang E, Vedul-Kjelsaas E. Aerobic interval training in standard treatment of outpatients with schizophrenia: a randomised controlled trial. Acta Psychiatr Scand. 2019 Sep 29. doi: 10.1111 — View Citation

Outcome

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