Schizophrenia Clinical Trial
Official title:
Feasibility and Relevance of High-Intensity Functional Training in Patients Undergoing Specialised Early Intervention Treatment for First-Episode Psychosis
The aim of the COPUS study is to investigate, whether it is possible to recruit and retain young people with first-episode psychosis, to an 8 week supervised High-Intensity Functional Training intervention (HIFT) (i.e. COPUS Intervention) and to investigate if oxygen uptake, body composition and physical function improves following participation in the intervention.
The introduction of specialized early intervention (SEI) is stated to be the most successful
recent addition to the treatment of schizophrenia and other psychotic illnesses. In Denmark,
SEI teams called OPUS, offer early intervention treatment (i.e. OPUS treatment) to young
patients between 18 and 35 years with first-episode psychosis. The OPUS treatment consists of
three main pillars: modified assertive treatment, family involvement, and social skill
training. OPUS treatment is delivered via multidisciplinary teams including psychiatrists,
psychologists, nurses, social workers, physiotherapists, and vocational therapists.
Despite considerable progress in treatment of schizophrenia, people diagnosed with
schizophrenia live significantly shorter lives, compared to the rest of the population. The
higher mortality rate can be partly explained by an increased risk of cardiovascular disease,
including metabolic syndrome, which may be documented already in the first months after start
of medical anti-psychotic treatment. It is widely acknowledged that physical activity
constitutes a cornerstone in the prevention of cardiovascular disease and metabolic syndrome.
Therefore, despite the influence of non-modifiable factors (e.g. genetics), it is reasonable
to assume that physical activity can promote health and prevent somatic disease in people
diagnosed with schizophrenia.
However, currently, physical activity is not included in early intervention treatment of
schizophrenia. Moreover, people with schizophrenia may experience anxiety, loss of
motivation, apathy and social isolation, which can constitute significant barriers for
adherence to physical activity. Existing knowledge in relation to physical activity behaviour
change and adoption is therefore difficult to transfer directly to people with schizophrenia.
Development and testing of new initiatives, which can be integrated into clinical practice,
and offered complementary to SEI are thus warranted.
Against this background, the aim of the current study (called the COPUS study) is to
investigate, whether it is possible to recruit and retain young people with first-episode
psychosis, to an 8-weeks supervised High-Intensity Functional Training (HIFT) intervention
(i.e. COPUS intervention) and to investigate if oxygen uptake, body composition and physical
function changes following participation in the COPUS intervention. The study is organized as
a randomized mixed methods feasibility study.
The COPUS intervention is offered in a private fitness centre in the local community. The
intervention contains three training sessions of one hour duration per week, with the
recommendation to the participants, to take part in at least two sessions per week.
The investigators aim to include 30 participants whom will be randomly assigned (1:1) to
either an intervention group receiving the COPUS intervention plus usual care (i.e. standard
OPUS treatment) or a control group including only receiving usual care (i.e. standard OPUS
treatment). Participants allocated to the control group are offered the COPUS intervention
after eight weeks.
The design and choice of methods reflect the complexity of the intervention (combination of
social and physical elements that are difficult to control and isolate) and the desire to
establish a scientifically informed basis for a subsequent, up-scaled, pragmatic randomized
multicentre study.
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