Fitforlife- Exercise in Care of Psychosis
Primary Purpose
Psychotic Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Physical exercise
Sponsored by
About this trial
This is an interventional treatment trial for Psychotic Disorders focused on measuring Psychotic disorders, Exercise, Cognition, Metabolic markers
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
Sites / Locations
- Stockholm cpounty councilRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Physical exercise
Arm Description
Specified circular training, 60 minutes, 1-3 times/week
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Change in Glycated Hemoglobin (HBA1c )
HBA1c measured in mmol/mol. Compared to normal values.
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.
Change in systolic and diastolic blood pressure
Blood pressure measured as mm hg. Will be compared to normal age related values.
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.
Full Information
NCT ID
NCT04239612
First Posted
October 28, 2019
Last Updated
January 21, 2020
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
1. Study Identification
Unique Protocol Identification Number
NCT04239612
Brief Title
Fitforlife- Exercise in Care of Psychosis
Official Title
Fitforlife- a Study of Mentor Led Physical Exercise for Persons Affected by Psychosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders
Keywords
Psychotic disorders, Exercise, Cognition, Metabolic markers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients attending open care units for psychosis will be invited to participate
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physical exercise
Arm Type
Other
Arm Description
Specified circular training, 60 minutes, 1-3 times/week
Intervention Type
Behavioral
Intervention Name(s)
Physical exercise
Intervention Description
Regular physical exercise in groups. Circular training: both strength and fitness
Primary Outcome Measure Information:
Title
Change in overall function from baseline to 6 months
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Body Mass Index(BMI) from baseline to 6 months
Description
Weight and height will be combined to report BMI in kg/m2. Values >25 overweight, >30 obesity.
Time Frame
6 months
Title
Change in Inflammatory markers from baseline to 6 months
Description
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.
Time Frame
6 months
Title
Changes from baseline to 6 months in cognitive function
Description
Measured with Cogstate brief battery (Computerized congitive assessment) - score of the summarised tests. Generated through a computerized program, comparsion to age-matched controls.
Time Frame
6 months
Title
Change in Glycated Hemoglobin (HBA1c )
Description
HBA1c measured in mmol/mol. Compared to normal values.
Time Frame
6 months
Title
Change in fitness
Description
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.
Time Frame
6 months
Title
Change in systolic and diastolic blood pressure
Description
Blood pressure measured as mm hg. Will be compared to normal age related values.
Time Frame
6 months
Title
Changes in blood lipids
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yvonne Forsell, Professor
Phone
+46709460991
Email
Yvonne.Forsell@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Skott, PhD
Phone
+46739660524
Email
Maria.skott@sll.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne Forsell, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stockholm cpounty council
City
Stockholm
ZIP/Postal Code
17177
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Skott, PhD
Phone
+46739660524
Email
maria.skott@sll.se
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29957552
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.
Results Reference
result
PubMed Identifier
29729687
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.
Results Reference
result
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Fitforlife- Exercise in Care of Psychosis
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