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

Not Applicable

Completed

• Conditions: Schizoaffective Disorder; Psychotic Disorders; Schizotypal Disorder; First Episode Psychosis; Schizophrenia
• Interventions: Other: The COPUS intervention; Other: Usual Care (OPUS treatment)

• Registration Number: NCT03409393
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Study Timeline

• Study First Submitted: 2018-01-04
• Study First Submitted QC: 2018-01-17
• Study Start: 2018-01-22
• Study First Posted: 2018-01-24
• Primary Completion: 2018-06-20
• Study Completion: 2018-08-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

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Exclusion Criteria

• Physical contraindications for physical activity
• Pregnant (self-reported)
• Unable to give adequately informed consent
• Mentally disabled

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention Group	The COPUS intervention	The COPUS intervention plus usual care (OPUS treatment).
Intervention Group	Usual Care (OPUS treatment)	The COPUS intervention plus usual care (OPUS treatment).
Control Group	Usual Care (OPUS treatment)	Usual care (OPUS treatment).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assessment of changes in fat percentage	Change from Baseline Fat Percentage at 2 months.	The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining fat percentage.
Assessment of changes in body weight	Change from Baseline Body Weight at 2 months.	The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining body weight.
Assessment of changes in bone mass	Change from Baseline Bone Mass at 2 months.	The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining bone mass.
Assessment of changes in Resting Blood Pressure	Change form Baseline Resting Blood Pressure at 2 months.	The participants' Resting Blood Pressure are tested according to the American Heart Association practice guidelines for blood pressure Measurement.
Assessment of changes in countermovement jump height	Change form Baseline Jump Height at 2 months.	Determination of potential changes in countermovement jump height measured using the non-invasive Optojump system (www.optojump.com)
Assessment of changes in Leg Muscle Strength	Change form Baseline Leg Muscle Strength at 2 months.	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.
Assessment of changes in Self-reported Physical Activity Behavior	Change from Baseline Physical Activity Behaviour at 2 months.	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.
Assessment of changes in Visceral Fat	Change from Baseline Visceral Fat at 2 months.	The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining visceral fat.
Assessment of changes in Hand Grip Strength	Change form Baseline Hand Grip Strength at 2 months.	Determination of potential changes in grip strength measured quantitatively using a hand dynamometer.
Assessment of changes in muscle mass	Change from Baseline Muscle Mass at 2 months.	The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining muscle mass.
Assessment of changes in Balance	Change form Baseline balance at 2 months.	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.

Trial Locations

Locations (1)

OPUS; 🇩🇰 Brøndby, Denmark