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临床试验/NCT04239612
NCT04239612已完成不适用

Fitforlife- a Study of Mentor Led Physical Exercise for Persons Affected by Psychosis

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2020年1月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
156
试验地点
2
主要终点
Change in overall function from baseline to 6 months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All persons attending open care psychiatric units for psychosis

排除标准

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

结局指标

主要结局

Change in overall function from baseline to 6 months

时间窗: 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.

次要结局

  • Change in Body Mass Index(BMI) from baseline to 6 months(6 months)
  • Changes in blood lipids(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)
  • Change in systolic and diastolic blood pressure(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yvonne Forsell

Professor

Karolinska Institutet

研究点 (2)

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