Schizophrenia
Conditions
Keywords
Exercise therapy, Cardiovascular disease, Risk
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.
Interventions
BEHAVIORALExercise therapy
OTHERFollow-up care as usual
Sponsors
Trondheim Kommune
Norwegian University of Science and Technology
St. Olavs Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| 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. |
| Real world functional behavior | Baseline, 1 year, 2 years. | Specific levels of functioning scale (SLOF). |
| Functional competence | Baseline,1 year, 2 years. | University of California San Diego Performance-Based Skills Assessments (UPSA-Brief). |
| 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. |
| 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. |
| Clinical symptoms. | Baseline, 1 year, 2 years. | Positive and Negative Syndrome Scale (PANSS). |
| Quality-adjusted life year | Baseline, 12 weeks, 1 year, 2 years. | EuroQol five dimensions questionnaire (EQ-5D) |
| Morning fasting blood levels. | Baseline, 12 weeks, 1 year, 2 years. | — |
| Tobacco | Baseline, 12 weeks, 1 year, 2 years. | Tobacco use measured by Fagerströms. |
| 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). |
| Motivation | Baseline, 12 weeks, 1 year, 2 years. | Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2). |
| Readiness/confidence to change | Baseline, 12 weeks, 1 year, 2 years. | Rulers (0-10 scale: readiness, importance, confidence). |
| Client Satisfaction | Baseline, 12 weeks, 1 year, 2 years. | Client Satisfaction Questionnaire (CSQ-8). |
| 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. |
| Patient activation | Baseline, 1 week, 12 weeks, 6 months, 1 year, 2 years | Patient Activation Measure (PAM-13 GH) |
| 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. |
Countries
Norway
Outcome results
None listed