Psychotic DisordersNCT04239612
Fitforlife- Exercise in Care of Psychosis
A study testing Physical exercise in people with Psychotic Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteSweden
- Study dates
- 21 Jan 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All persons attending open care psychiatric units for psychosis
Who cannot join
- Judged by the responsible psychiatrist that physical exercise in groups is not suitable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fitforlife- a Study of Mentor Led Physical Exercise for Persons Affected by Psychosis
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.
Read the 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.
- Conditions
- Psychotic Disorders
- Being tested
- Physical exercise
- Keywords
- Psychotic disorders, Exercise, Cognition, Metabolic markers
- Medical subject headings
- Psychotic Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseBehavioural
Regular physical exercise in groups. Circular training: both strength and fitness
| Study group | Role | What they receive |
|---|---|---|
| Physical exercise | Other | Specified circular training, 60 minutes, 1-3 times/week Receives: Behavioral: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall function from baseline to 6 months
Overall function according to sum of items in WHODAS (World Health Organization Disability Assessment Schedule). 36 items, Score 0-5 on each item, higher values- lower function.
Measured: 6 months
Secondary outcomes (7)
Change in Body Mass Index(BMI) from baseline to 6 months
Weight and height will be combined to report BMI in kg/m2. Values >25 overweight, >30 obesity.
Measured: 6 months
Change in Inflammatory markers from baseline to 6 months
Interleukin-6 (Il6), Tumour necrosis Factor (TNFalfa), C-reaktive protein(CRP) all measured in pg/ml. No normal values exists. Will be compared to healthy controls.
Measured: 6 months
Changes from baseline to 6 months in cognitive function
Measured with Cogstate brief battery (Computerized congitive assessment) - score of the summarised tests. Generated through a computerized program, comparsion to age-matched controls.
Measured: 6 months
Change in Glycated Hemoglobin (HBA1c )
HBA1c measured in mmol/mol. Compared to normal values.
Measured: 6 months
Change in fitness
Fitness measured as VO2 (Volyme Oxygene) max in a bicycle submax test (Ekblom-Bak). Will be compared to tables for normal values according to age.
Measured: 6 months
Change in systolic and diastolic blood pressure
Blood pressure measured as mm hg. Will be compared to normal age related values.
Measured: 6 months
Changes in blood lipids
Blood lipids includes cholesterol (LDL-C) measured in mg/dl, Low density lipoprotein (LDL) High density lipoprotein-cholesterol (HDL-C) and triglycerides- all measured in mg/dl. Will be compared to standard normal values according to age.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start21 Jan 2020
- Primary completion30 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients attending open care units for psychosis will be invited to participate
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Region Skane, Region Halland
- Responsible party
- Principal investigator, Yvonne Forsell, Karolinska Institutet
- Investigators
- Yvonne Forsell, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239612
- Sponsor's protocol ID
- 102
- Status last verified
- Jun 2024
- First submitted
- 28 Oct 2019
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29957552Hallgren 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.
PubMed 29729687Pegelow AC, Skott M, Ekblom O, Lavebratt C, Forsell Y. The impact of a national exercise intervention on lifestyle habits among individuals with schizophrenia spectrum disorders: results from the FitForLife intervention study. BMC Res Notes. 2026 Apr 15;19(1):187. doi: 10.1186/s13104-026-07801-x.
PubMed 41987238
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fitforlife- a Study of Mentor Led Physical Exercise for Persons Affected by Psychosis
- ClinicalTrials.gov ID
- NCT04239612
- Acronym / sponsor ID
- 102
- Conditions
- Psychotic Disorders
- Keywords
- Psychotic disorders, Exercise, Cognition, Metabolic markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, Region Skane, Region Halland
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients attending open care units for psychosis will be invited to participate
| Arm | Type | Receives |
|---|---|---|
| Physical exercise | Other | Behavioral: Physical exerciseSpecified circular training, 60 minutes, 1-3 times/week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All persons attending open care psychiatric units for psychosis
Key exclusion criteria (1 listed)
- Judged by the responsible psychiatrist that physical exercise in groups is not suitable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exerciseRegular physical exercise in groups. Circular training: both strength and fitness | Behavioural | Physical exercise |
Primary outcome
Change in overall function from baseline to 6 months
Time frame: 6 months
Overall function according to sum of items in WHODAS (World Health Organization Disability Assessment Schedule). 36 items, Score 0-5 on each item, higher values- lower function.
7 secondary outcomes
Change in Body Mass Index(BMI) from baseline to 6 months
Time frame: 6 months
Change in Inflammatory markers from baseline to 6 months
Time frame: 6 months
Changes from baseline to 6 months in cognitive function
Time frame: 6 months
Change in Glycated Hemoglobin (HBA1c )
Time frame: 6 months
Change in fitness
Time frame: 6 months
Change in systolic and diastolic blood pressure
Time frame: 6 months
Changes in blood lipids
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Results publication: PubMed 29957552Lambden 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.
- Results publication: PubMed 29729687Hallgren 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.
- Derived from this study: PubMed 41987238Pegelow AC, Skott M, Ekblom O, Lavebratt C, Forsell Y. The impact of a national exercise intervention on lifestyle habits among individuals with schizophrenia spectrum disorders: results from the FitForLife intervention study. BMC Res Notes. 2026 Apr 15;19(1):187. doi: 10.1186/s13104-026-07801-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Forsell, Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise in people with Psychotic Disorders, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in overall function from baseline to 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04239612, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.