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

NCT ID: NCT03409393

Last Updated: 2018-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-22
• Study Completion Date: 2018-08-01

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.

Conditions

Schizophrenia; Schizotypal Disorder; First Episode Psychosis; Psychotic Disorders; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group

The COPUS intervention plus usual care (OPUS treatment).

Group Type: EXPERIMENTAL

The COPUS intervention

Intervention Type: OTHER

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)

Intervention Type: OTHER

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.

Control Group

Usual care (OPUS treatment).

Group Type: OTHER

Usual Care (OPUS treatment)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Julie Midtgaard

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie Midtgaard, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The University Hospitals Centre for Health Research (UCSF) / Copenhagen University Hospital (Rigshospitalet)

Helle Schnor, Ph.D.

Role: STUDY_DIRECTOR

Mental health services in the Capital Region of Denmark, Psychiatric Center Glostrup

Locations

OPUS

Brøndby, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 34412705 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31226959 (View on PubMed)

Related Links

http://www.ucsf.dk

Official institutional website

Other Identifiers

119481

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

COPUS

Identifier Type: -

Identifier Source: org_study_id