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

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Behavioral: Exercise therapy; Other: Follow-up care as usual

• Registration Number: NCT02743143
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-19
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise therapy	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.
Follow-up care as usual	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.

Primary Outcome Measures

Name	Time	Method
Change in peak oxygen uptake.	Baseline, 12 weeks, 1 year, 2 years.	Peak oxygen uptake after the training period subtracted Peak oxygen uptake at baseline.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St. Olavs University Hospital, Division of Psychiatry, Department of Østmarka; 🇳🇴 Trondheim, Norway