Clinical trial NCT04239612: Fitforlife- Exercise in Care of Psychosis
Official title: Fitforlife- a Study of Mentor Led Physical Exercise for Persons Affected by Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Keywords: Psychotic disorders
Exercise
Cognition
Metabolic markers
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: Region Skåne
name: Region Halland
First posted: 2020-01-27
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients attending open care units for psychosis will be invited to participate
Primary purpose: TREATMENT

Brief summary: Persons affected by psychosis have a shorter life expectancy mainly due to metabolic disorders. This is partly due to the drugs but also to a sedentary life style.

It is often a life long disorder with decreased overall function and thus need of life long care, both informal and formal. It is also a highly stigmatising disorder.

We are aiming at adding peer mentor led regular physical exercise to the open care of psychosis. it is well-known that physical exercise increase overall function, decrease metabolic risk factors and increase cognition. By using educated peer mentors who will lead the exercise sessions this will have an anti-stigmatising effect and improve self-confidence.

Detailed description: Purpose and aims The overall purpose is to integrate peer-mentor supervised regular physical exercise in the open care of persons affected by psychosis. For specific research questions see separate information.

Recruitment of units and mentors Psychiatric open care units who are responsible for care of persons affected by psychosis will be contacted. First in Stockholm then in the rest of Sweden.

Those who are interested will assign 1-2 local contact persons from the staff and recruit 4 potential peer mentors among their patients.

Peer mentor education The peer mentors will be educated to be able to lead physical exercise sessions for other patients. Two units (8 mentors) will be educated together and the local contact persons will also attend. The education consists of three half days and is lead by a person educated in health pedagogics and physical exercise. It consists of theory and practice about physical exercise sessions with focus on circular training. A lof of emphasis will be put put on leadership and encouragement. The curriculum of the education is based on the pilot study.

Recruitment of participants The local contact persons together with the health care staff at the local units will recruit participants to the exercise sessions.

They will also perform the initial and 6 month follow up examinations. In order to do this they will receive education and support from the research team. A carefully written instruction is administered. This procedure is described in detail in the study protocol.

Exercise sessions Each included unit will have exercise sessions at the unit. Numbers/week depends on the number of recruited participants. Schedule will be done by the local peer mentors and the local contact person together. The sessions will be entirely led by the peer mentors.

Before the sessions the local contact persons will register the participants when they arrive. After the session the peer mentor will report to the local contact person how the session went. These data will be transferred to the research team.

Support to the peer mentors For six months the educated peer mentors will have support from a health pedagogical team. The support is both face-to-face and electronic.

Time period The study will record data for 6 months.

Eligibility criteria: Inclusion Criteria:

• All persons attending open care psychiatric units for psychosis

Exclusion Criteria:

• Judged by the responsible psychiatrist that physical exercise in groups is not suitable

Primary outcomes:
measure: Change in overall function from baseline to 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change in Body Mass Index(BMI) from baseline to 6 months
timeFrame: 6 months
measure: Change in Inflammatory markers from baseline to 6 months
timeFrame: 6 months
measure: Changes from baseline to 6 months in cognitive function
timeFrame: 6 months
measure: Change in Glycated Hemoglobin (HBA1c )
timeFrame: 6 months
measure: Change in fitness
timeFrame: 6 months
measure: Change in systolic and diastolic blood pressure
timeFrame: 6 months
measure: Changes in blood lipids
timeFrame: 6 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholm county council
Study officials:
affiliation: Karolinska Institutet
name: Yvonne Forsell, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lambden B, Berge J, Forsell Y. Structured physical exercise and recovery from first episode psychosis in young adults, the FitForLife study. Psychiatry Res. 2018 Sep;267:346-353. doi: 10.1016/j.psychres.2018.06.001. Epub 2018 Jun 19.
citation: Hallgren M, Skott M, Ekblom O, Firth J, Schembri A, Forsell Y. Exercise effects on cognitive functioning in young adults with first-episode psychosis: FitForLife. Psychol Med. 2019 Feb;49(3):431-439. doi: 10.1017/S0033291718001022. Epub 2018 May 6.