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

Schizophrenia Clinical Trial

— COPUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03409393
• Other study ID #: COPUS
• Secondary ID: 119481
• Status: Completed
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: September 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 1, 2018
• Est. primary completion date: June 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• First Episode Psychosis
• Mental Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizotypal Disorder

Intervention

Other:
• The COPUS intervention
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 (OPUS treatment)
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.

Locations

Country	Name	City	State
Denmark	OPUS	Brøndby

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Mental Health Services in the Capital Region, Denmark, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Monitoring of training intensity (for the Intervention Group only)	Determination of whether the training intensity is adequate to increase Physical Fitness, the workload during training is continuously measured. A validated device called Actiheart which is both an accelerometer and a heart rate monitor is used to measure workload.	Through study completion, an average of 4 months
Other	Adverse events	We will continuously record adverse events that may arise as a result of the intervention, including physical damage, discomfort and any deterioration of symptoms. The adverse events will be registred both in the intervention period and in the Control Group training period.	Through study completion, an average of 4 months
Other	Resource Consumption	In order to evaluate the sustainability of the intervention, we want to register how much time (in minutes) OPUS staff spends on the project	Through study completion, an average of 4 months
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

External Links

•   Official institutional website