Fitforlife- Exercise in Care of Psychosis

January 21, 2020 updated by: Yvonne Forsell, Karolinska Institutet

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

Unknown

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

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Stockholm, Sweden, 17177
        • Recruiting
        • Stockholm cpounty council
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Yvonne Forsell, Professor, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2020

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

January 21, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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