- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04239612
Fitforlife- Exercise in Care of Psychosis
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yvonne Forsell, Professor
- Phone Number: +46709460991
- Email: Yvonne.Forsell@ki.se
Study Contact Backup
- Name: Maria Skott, PhD
- Phone Number: +46739660524
- Email: maria.skott@sll.se
Study Locations
-
-
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Stockholm, Sweden, 17177
- Recruiting
- Stockholm cpounty council
-
Contact:
- Maria Skott, PhD
- Phone Number: +46739660524
- Email: maria.skott@sll.se
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Physical exercise
Specified circular training, 60 minutes, 1-3 times/week
|
Regular physical exercise in groups.
Circular training: both strength and fitness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body Mass Index(BMI) from baseline to 6 months
Time Frame: 6 months
|
Weight and height will be combined to report BMI in kg/m2.
Values >25 overweight, >30 obesity.
|
6 months
|
Change in Inflammatory markers from baseline to 6 months
Time Frame: 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.
|
6 months
|
Changes from baseline to 6 months in cognitive function
Time Frame: 6 months
|
Measured with Cogstate brief battery (Computerized congitive assessment) - score of the summarised tests.
Generated through a computerized program, comparsion to age-matched controls.
|
6 months
|
Change in Glycated Hemoglobin (HBA1c )
Time Frame: 6 months
|
HBA1c measured in mmol/mol.
Compared to normal values.
|
6 months
|
Change in fitness
Time Frame: 6 months
|
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.
|
6 months
|
Change in systolic and diastolic blood pressure
Time Frame: 6 months
|
Blood pressure measured as mm hg.
Will be compared to normal age related values.
|
6 months
|
Changes in blood lipids
Time Frame: 6 months
|
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.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yvonne Forsell, Professor, Karolinska Institutet
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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