Feasibility and Relevance of High-Intensity Functional Training in Patients With First-Episode Psychosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility and Relevance of High-Intensity Functional Training in Patients Undergoing Specialised Early Intervention Treatment for First-Episode Psychosis

Conditions
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Schizophrenia, Schizotypal Disorder, First Episode Psychosis, Psychotic Disorders, Schizoaffective Disorder

Intervention / Treatment
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* Other: The COPUS intervention
* Other: Usual Care (OPUS treatment)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 35 years Diagnosed with Schizophrenia or Schizotypal disorders Undergoing OPUS treatment for at least 6 months or stabilized medical anti-psychotic treatment Danish speaking Exclusion Criteria: Physical contraindications for physical activity Pregnant (self-reported) Unable to give adequately informed consent Mentally disabled

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>The COPUS intervention plus usual care (OPUS treatment). | Other: The COPUS intervention<br>* 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.<br>Other: Usual Care (OPUS treatment)<br>* 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.<br>|
| Other: Control Group<br>Usual care (OPUS treatment). | Other: Usual Care (OPUS treatment)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of changes in Physical Fitness (VO2max) | Assessed by the maximum amount of oxygen the body can utilize during a specified period of intense exercise. | Change from Baseline Physical Fitness (VO2max) at 2 months. | 
| Recruitment Rate | Registration of patients enrolled in the study compared to the total number of eligible patients. | Registration of recruitment occurs in the 4 weeks prior to the baseline tests. | 
| Retention Rate | Registration of the participants attendance in the High-Intensity Functional Training compared with the number of possible training sessions during the period. | From baseline up to 4 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of changes in body weight | The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining body weight. | Change from Baseline Body Weight at 2 months. | 
| Assessment of changes in fat percentage | The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining fat percentage. | Change from Baseline Fat Percentage at 2 months. | 
| Assessment of changes in bone mass | The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining bone mass. | Change from Baseline Bone Mass at 2 months. | 
| Assessment of changes in muscle mass | The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining muscle mass. | Change from Baseline Muscle Mass at 2 months. | 
| Assessment of changes in Visceral Fat | The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining visceral fat. | Change from Baseline Visceral Fat at 2 months. | 
| Assessment of changes in Resting Blood Pressure | The participants' Resting Blood Pressure are tested according to the American Heart Association practice guidelines for blood pressure Measurement. | Change form Baseline Resting Blood Pressure at 2 months. | 
| Assessment of changes in countermovement jump height | Determination of potential changes in countermovement jump height measured using the non-invasive Optojump system (www.optojump.com) | Change form Baseline Jump Height at 2 months. | 
| Assessment of changes in Leg Muscle Strength | Determination of potential changes in leg muscle strength by the non-invasive 30-Second Chair Stand test. The test measures how many times the participant can reach a full standing position from a sitting position in 30 seconds. Score range from 0 and up with a higher score being considered as a better outcome. | Change form Baseline Leg Muscle Strength at 2 months. | 
| Assessment of changes in Hand Grip Strength | Determination of potential changes in grip strength measured quantitatively using a hand dynamometer. | Change form Baseline Hand Grip Strength at 2 months. | 
| Assessment of changes in Balance | Determination of potential changes in balance using the Flamingo Balance Test. The participant stands on a 3 centimeter wide beam while holding the instructors hand. The tests then measures how many times the participant loses balance in 60 seconds.Score range from 0 and up with a lower score being considered as a better outcome. | Change form Baseline balance at 2 months. | 
| Assessment of changes in Self-reported Physical Activity Behavior | Assesment of changes in self-reported physical activity behaviour using the Physical Activity Scale (PAS). The PAS measures self-reported amount of time spent on different physical activities, such as sports, work, and leisure time during 24 hours on an average weekday. The activities are organized in nine different metabolic equivalent (MET) levels ranging from sleep/rest (0.9 METs) to high-intensity physical activities (>6 METs). MET is the Metabolic Equivalent of Task and is a physiological measure expressing the energy cost of physical activities and is defined as the ratio of metabolic rate (and therefore the rate of energy consumption) during a specific physical activity to a reference metabolic rate. Therefore, higher MET scores in the Physical Activity Scale indicates a better outcome than lower scores. | Change from Baseline Physical Activity Behaviour at 2 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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