REK ID: 2015/1611
ClinicalTrials: NCT02743143
Abstract
Background: Patients with schizophrenia have disabling symptoms and cognitive deficits that limit motivation, drive, social- and occupational performance, quality of life, self-efficacy and a leads to a high risk of dying from cardiovascular disease. Explanatory trials suggest exercise improves cognitive functioning, negative symptoms, QOL and reduce the risk of CVD. However, due to their illness, the participation in regular exercise is challenging for patients with schizophrenia. It has not been tested if patients with schizophrenia can participate in long-term exercise therapy, and whether providing long-term exercise therapy is beneficial compared to today’s usual care.
Objectives: To examine the effectiveness of long-term supervised exercise, motivational interview and comprehensive support from the community services (suEX) compared with usual care (UC) in adherence to exercise, cardiovascular risk factors, symptoms, and function.
Design: Single centre randomised controlled trial, open label, parallel group design. Subjects are randomised to either a suEX interventional group or a UC control group. An independent university randomisation centre will use computerised random numbers to allocate treatment group.
Patients: 60 women and men, 18-65 years old, with ICD-10 schizophrenia (F20 to F29) will be recruited.
Interventions: suEX consists of high aerobic intensity training and maximal strength training 2 times per week at the Hospital’s Exercise Training Clinic. Patients will receive Motivational Interview and comprehensive support to facilitate adherence. The intervention is based on a supported course of treatment and is facilitated by the corporation between the primary and secondary health services. The UC group will receive the usual physical activity offered by the primary health care system. UC include the traditional physical activity advice from the Norwegian Directorate of Health.
Main outcome measures: Adherence, peak oxygen uptake, walking economy, maximal strength, conventional CVD risk factors, psychometric variables, functional ability, function in activities of daily living, hospital stays and need for care. Outcome measures will be taken at; baseline (T0) and 12 weeks (T1). Thereafter; 6 months (T2), 1 year (T3), 2 years (T4) post randomisation.
Results: The PhD candidate will publish three papers and finish the thesis within may 2018. The findings will be disseminated via peer reviewed journals and conferences as well as user group meetings.
Discussion: There is a great need to explore the effectiveness of long-term exercise in patients with schizophrenia. Our research group is among few groups with infrastructure, practice and expertise to carry out this trial. The results have implications for clinical practice.
Trial registration: To be registered in ClinicalTrials.gov
Funding: Applied.
