Clinical trial NCT03409393: Feasibility and Relevance of High-Intensity Functional Training in Patients With First-Episode Psychosis
Official title: Feasibility and Relevance of High-Intensity Functional Training in Patients Undergoing Specialised Early Intervention Treatment for First-Episode Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizotypal Disorder
First Episode Psychosis
Psychotic Disorders
Schizoaffective Disorder
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
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Mental Health Services in the Capital Region, Denmark
First posted: 2018-01-24
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of changes in Physical Fitness (VO2max)
timeFrame: Change from Baseline Physical Fitness (VO2max) at 2 months.
measure: Recruitment Rate
timeFrame: Registration of recruitment occurs in the 4 weeks prior to the baseline tests.
measure: Retention Rate
timeFrame: From baseline up to 4 months.
Secondary outcomes:
measure: Assessment of changes in body weight
timeFrame: Change from Baseline Body Weight at 2 months.
measure: Assessment of changes in fat percentage
timeFrame: Change from Baseline Fat Percentage at 2 months.
measure: Assessment of changes in bone mass
timeFrame: Change from Baseline Bone Mass at 2 months.
measure: Assessment of changes in muscle mass
timeFrame: Change from Baseline Muscle Mass at 2 months.
measure: Assessment of changes in Visceral Fat
timeFrame: Change from Baseline Visceral Fat at 2 months.
measure: Assessment of changes in Resting Blood Pressure
timeFrame: Change form Baseline Resting Blood Pressure at 2 months.
measure: Assessment of changes in countermovement jump height
timeFrame: Change form Baseline Jump Height at 2 months.
measure: Assessment of changes in Leg Muscle Strength
timeFrame: Change form Baseline Leg Muscle Strength at 2 months.
measure: Assessment of changes in Hand Grip Strength
timeFrame: Change form Baseline Hand Grip Strength at 2 months.
measure: Assessment of changes in Balance
timeFrame: Change form Baseline balance at 2 months.
measure: Assessment of changes in Self-reported Physical Activity Behavior
timeFrame: Change from Baseline Physical Activity Behaviour at 2 months.
Other outcomes:
measure: Monitoring of training intensity (for the Intervention Group only)
timeFrame: Through study completion, an average of 4 months
measure: Adverse events
timeFrame: Through study completion, an average of 4 months
measure: Resource Consumption
timeFrame: Through study completion, an average of 4 months
Locations:
city: Brøndby
country: Denmark
facility: OPUS
Study officials:
affiliation: The University Hospitals Centre for Health Research (UCSF) / Copenhagen University Hospital (Rigshospitalet)
name: Julie Midtgaard, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mental health services in the Capital Region of Denmark, Psychiatric Center Glostrup
name: Helle Schnor, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Midtgaard J, Schnor H, Bjerre ED, Jespersen T, Jelsoe N, Frolund N, Seier S, Ronbog JW, Nordsborg NB, Ebdrup BH. Exercise training complementary to specialised early intervention in patients with first-episode psychosis: a feasibility randomised trial. Pilot Feasibility Stud. 2021 Aug 19;7(1):162. doi: 10.1186/s40814-021-00900-5.
citation: Larsen LQ, Schnor H, Tersbol BP, Ebdrup BH, Nordsborg NB, Midtgaard J. The impact of exercise training complementary to early intervention in patients with first-episode psychosis: a qualitative sub-study from a randomized controlled feasibility trial. BMC Psychiatry. 2019 Jun 21;19(1):192. doi: 10.1186/s12888-019-2179-3.