NCT04239612

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

3.4 years

First QC Date

October 28, 2019

Last Update Submit

June 26, 2024

Conditions

Psychotic Disorders

Keywords

Psychotic disordersExerciseCognitionMetabolic markers

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (7)

  • Change in Body Mass Index(BMI) from baseline to 6 months

    6 months

  • Change in Inflammatory markers from baseline to 6 months

    6 months

  • Changes from baseline to 6 months in cognitive function

    6 months

  • Change in Glycated Hemoglobin (HBA1c )

    6 months

  • Change in fitness

    6 months

  • +2 more secondary outcomes

Study Arms (1)

Physical exercise

OTHER

Specified circular training, 60 minutes, 1-3 times/week

Behavioral: Physical exercise

Interventions

Physical exerciseBEHAVIORAL

Regular physical exercise in groups. Circular training: both strength and fitness

Physical exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All persons attending open care psychiatric units for psychosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stockholm county council

Stockholm, 17177, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 29957552RESULT

  • 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.

    PMID: 29729687RESULT

MeSH Terms

Conditions

Psychotic DisordersMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Yvonne Forsell, Professor

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All patients attending open care units for psychosis will be invited to participate
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 28, 2019

First Posted

January 27, 2020

Study Start

January 21, 2020

Primary Completion

June 30, 2023

Study Completion

December 31, 2023

Last Updated

June 28, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)