Feasibility and Relevance of High-Intensity Functional Training in Patients With First-Episode Psychosis
Condition: Schizophrenia; Schizotypal Disorder; First Episode Psychosis; Psychotic Disorders; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): The COPUS intervention; Usual Care (OPUS treatment)
Intervention type(s): Other; Other
Intervention description(s): The COPUS intervention consists of 8 weeks of High-Intensity Functional Training (HIFT). The frequency of the training is 3 sessions per week and the duration is one hour per session. The intervention is group-based and supervised. Each training session includes warm-up (15 min), followed by 30 minutes of HIFT based on a range of varied functional exercises, including elements of strength training and aerobic exercise. The sessions are supervised by a trained physiotherapist and exercise physiologist supported by 2 two trained bachelor students in Sports Science.; Usual care include specialised early intervention treatment (OPUS treatment) and consists of three main pillars: modified assertive treatment, family involvement, and social skill training. OPUS treatment is delivered via multidisciplinary teams include psychiatrists, psychologists, nurses, social workers, physiotherapists, and vocational therapists. All team members, except for the psychiatrist, function as case managers. The ratio of patients to case managers must not exceed 12:1.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The participants will be randomly assigned (1:1) to either an Intervention Group that in the initial study phase (week 0-8) receives the COPUS intervention plus usual care (i.e. OPUS treatment) or to a Control Group that only receives usual care in the initial phase. In the second phase of the study (week 8-16), participants allocated to the control group are offered the COPUS intervention.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Human; Denmark; Adult; Adolescent; Young Adult; Male; Female; Physical Activity; Maximum Oxygen Consumption; Resistance Training; High-Intensity Functional Training; Aerobic Exercise; Motivation; Feasibility; Relevance; Health Behavior