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临床试验/NCT05673941
NCT05673941进行中(未招募)不适用

"InMotion" - Physical Training With Creative Movement as an Intervention for Adults With Schizophrenia

Örebro University, Sweden3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
3
主要终点
Positive and Negative Syndrome Scale (PANSS)

研究概览

简要总结

InMotion is a randomized controlled study where adults with schizophrenia and schizophrenia-similar conditions, will be recruited to receive physical training with creative movements as an intervention, twice a week for a period of 12 weeks. The main outcome is changes in schizophrenia-related symptoms, secondary outcomes are changes in quality of life, physical and cognitive function, brain activity, and how the intervention is experienced by the participants.

详细描述

Schizophrenia (SCZ) is among the world's top ten causes of long-term disability (World Health Organization, 2004). The major symptoms of SCZ include hallucinations, delusions, affective flattening, apathy and cognitive impairment. These symptoms lead to major problems in social and occupational functioning, and in self-care.

Our primary aim is to investigate the effects of 12-weeks of physical training with creative movement as an intervention given in addition to ongoing pharmacological treatment, in treating SCZ-symptoms compared to a control group. Secondary aim is to provide results regarding the effects of the intervention on (a) clinical symptom measures and quality of life, (b) levels of physical activity, physical function and measures of general health indicators, (a) clinical symptom measures and quality of life, (b) levels of physical activity, physical function and measures of general health indicators, (c) error detection and conflict resolution on the prefrontal cortex, memory and context processing (d) fluency of speak, and (e) emotional induction and regulation on specific emotions on the frontal cortex. Trough qualitative interviews, we will examine the participants' and their relative parties' experiences from taking part of the intervention and eventual experienced effects from it.

This study, called InMotion, is a prospective randomized controlled trial where the study participants will be randomized to 12-weeks of physical training with creative movement as an intervention in addition to standard care (intervention group) or to standard care alone (control group). The target group consists of adults with SCZ or SCZ-similar condition.

The intervention consists of organized training sessions in group, 2 times a week. The control group receives standard medical care and gets access to the intervention in digital form after the study has ended. The outcomes are measured at baseline, after 6 and 12 weeks, 6 months and 12 months. At all follow-ups, data are collected for both the intervention and control groups. The trial is being conducted in Örebro, Sweden. The study follows the standard methodology of intervention research.

60 patients with SCZ will be recruited continuously by staff at the psychiatry at the university hospital in Örebro. When matched to inclusion and exclusion criteria, written and informed consent will be obtained from all participants willing to participate. 30 patients will be randomized to participate in creative physical training in addition to continuing their conventional treatment plan (SCZ-I group) and 30 patients will be randomized to control group and receive treatment as usual (SCZ-C). Randomization to SCZ-I and SCZ-C groups will be done by sealed envelopes given to the participants after baseline measures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Participants will be pseudonymized by using a study code. The researchers will be blind to group allocation when analyzing data.

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

  • Schizophrenia diagnosis or schizophrenia similar condition, age 18-65 years, performing physical activity less than 150 min/week.

排除标准

  • Current or recent history of substance abuse, bipolar disorder, severe autism, suicidal, severe physical illness, inability to read and understand the Swedish language and inability to interact with other people in a group.

结局指标

主要结局

Positive and Negative Syndrome Scale (PANSS)

时间窗: 45 minutes

The Positive and Negative Syndrome Scale (PANSS) is an established psychiatric rating system that is an operationalized, drug-sensitive instrument that offers balanced representation of positive and negative symptoms and estimates their relationship to one another and to global (or general) psychopathology.

次要结局

  • Clinical Global Impression - Severity scale (CGI-S)(2.5 minutes)
  • Clinical Global Impression - Improvement scale (CGI-I)(2.5 minutes)
  • The Calgary Depression Scale for Schizophrenics (CDSS)(10 minutes)
  • Body Awareness Questionnaire (BAQ-sv)(10 minutes)
  • The personal and social performance scale (PSP)(10 minutes)
  • EQ-5D-5L(5 minutes)
  • Burden of Care - Visual Analogue Scale(5 minutes)
  • Physiological measures(15 minutes)
  • Body measures(5 minutes)
  • Motion Capture(60 minutes)
  • fNIRS, EEG, and eye-tracking(45 minutes)
  • Postural stability test/balance(10 minutes)
  • Chair stand test(3 minutes)
  • Everyday activity(7 days)
  • Blood samples(5 minutes)
  • Interviews(60 minutes)

研究者

发起方
Örebro University, Sweden
申办方类型
Other
责任方
Sponsor

研究点 (3)

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