Background:
Antipsychotic medications are associated with development of metabolic side-effects.
Patients with schizophrenia have a four-fold higher prevalence of metabolic syndrome, and
a two-to-three-fold higher risk of cardiovascular diseases compared to the general
population. These factors may contribute to the premature mortality of 15-20 years
observed in people with schizophrenia. The increased morbidity and mortality in people
with mental illness can be explained by several risk factors, including physical
inactivity.
Evidence suggests that exercise can have beneficial effects on multiple cardiometabolic
outcomes, and improve clinical symptoms, quality of life, global functioning, and reduce
negative and depressive symptoms in people with schizophrenia. In general, greater
effects are seen for higher doses of aerobic exercise and motivational theory-based
interventions supervised by exercise professionals. However, because of strict inclusion
criteria, the external validity of existing studies is limited, and effectiveness studies
are urgently needed
Objectives:
The primary objective is to determine the effectiveness of participation in a four-month
supervised, gym-based exercise program among people treated with antipsychotic medication
compared to usual care on patient-rated recovery (primary outcome).
Secondary objectives are to examine if the gym-based exercise program compared to usual
care improves the following:
Mental health
Health-related quality of life
Behavioral and functional symptoms
Metabolic health
As tertiary objectives, we will investigate if:
Prolongation of subsidized gym membership in addition to motivational text messages
(extended support) will be superior to subsidized gym membership alone (minimal
support), and to treatment as usual in relation to post-intervention adoption of
physical activity.
The exercise program impacts the quality of life and physical and mental health of
the participants' primary relative.
Participation in the gym-based program is associated with a reduction in the
participants' use of mental health care services.
The exercise program is cost-effective.
Design:
This is a multi-center, pragmatic, randomized (1:2) superiority trial to compare a
4-month, supervised, gym-based exercise training program to usual care. The pragmatic
nature of the trial entails that it is designed to evaluate the effectiveness of
interventions in real-life routine practice conditions.
In order to explore different ways to support sustainment (i.e., post-intervention
adherence/adoption of physical activity), and to guide strategies to facilitate
adherence, we will do "a study within a trial" (SWAT). Hence participants randomized to
the intervention at baseline, will be randomized (allocation ratio 1:1) after four months
to minimal vs. extended support with regards to sustainment of physical activity.