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临床试验/NCT03409393
NCT03409393已完成不适用

Feasibility and Relevance of High-Intensity Functional Training in Patients Undergoing Specialised Early Intervention Treatment for First-Episode Psychosis

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2018年1月22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
27
试验地点
2
主要终点
Recruitment Rate

研究概览

简要总结

The aim of the COPUS study is to investigate, whether it is possible to recruit and retain young people with first-episode psychosis, to an 8 week supervised High-Intensity Functional Training intervention (HIFT) (i.e. COPUS Intervention) and to investigate if oxygen uptake, body composition and physical function improves following participation in the intervention.

详细描述

The introduction of specialized early intervention (SEI) is stated to be the most successful recent addition to the treatment of schizophrenia and other psychotic illnesses. In Denmark, SEI teams called OPUS, offer early intervention treatment (i.e. OPUS treatment) to young patients between 18 and 35 years with first-episode psychosis. The OPUS treatment consists of three main pillars: modified assertive treatment, family involvement, and social skill training. OPUS treatment is delivered via multidisciplinary teams including psychiatrists, psychologists, nurses, social workers, physiotherapists, and vocational therapists.

Despite considerable progress in treatment of schizophrenia, people diagnosed with schizophrenia live significantly shorter lives, compared to the rest of the population. The higher mortality rate can be partly explained by an increased risk of cardiovascular disease, including metabolic syndrome, which may be documented already in the first months after start of medical anti-psychotic treatment. It is widely acknowledged that physical activity constitutes a cornerstone in the prevention of cardiovascular disease and metabolic syndrome. Therefore, despite the influence of non-modifiable factors (e.g. genetics), it is reasonable to assume that physical activity can promote health and prevent somatic disease in people diagnosed with schizophrenia.

However, currently, physical activity is not included in early intervention treatment of schizophrenia. Moreover, people with schizophrenia may experience anxiety, loss of motivation, apathy and social isolation, which can constitute significant barriers for adherence to physical activity. Existing knowledge in relation to physical activity behaviour change and adoption is therefore difficult to transfer directly to people with schizophrenia. Development and testing of new initiatives, which can be integrated into clinical practice, and offered complementary to SEI are thus warranted.

Against this background, the aim of the current study (called the COPUS study) is to investigate, whether it is possible to recruit and retain young people with first-episode psychosis, to an 8-weeks supervised High-Intensity Functional Training (HIFT) intervention (i.e. COPUS intervention) and to investigate if oxygen uptake, body composition and physical function changes following participation in the COPUS intervention. The study is organized as a randomized mixed methods feasibility study.

The COPUS intervention is offered in a private fitness centre in the local community. The intervention contains three training sessions of one hour duration per week, with the recommendation to the participants, to take part in at least two sessions per week.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 35 years
  • Diagnosed with Schizophrenia or Schizotypal disorders
  • Undergoing OPUS treatment for at least 6 months or stabilized medical anti-psychotic treatment
  • Danish speaking

排除标准

  • Physical contraindications for physical activity
  • Pregnant (self-reported)
  • Unable to give adequately informed consent
  • Mentally disabled

结局指标

主要结局

Recruitment Rate

时间窗: Registration of recruitment occurs in the 4 weeks prior to the baseline tests.

Registration of patients enrolled in the study compared to the total number of eligible patients.

Assessment of changes in Physical Fitness (VO2max)

时间窗: Change from Baseline Physical Fitness (VO2max) at 2 months.

Assessed by the maximum amount of oxygen the body can utilize during a specified period of intense exercise.

Retention Rate

时间窗: From baseline up to 4 months.

Registration of the participants attendance in the High-Intensity Functional Training compared with the number of possible training sessions during the period.

次要结局

  • Assessment of changes in fat percentage(Change from Baseline Fat Percentage at 2 months.)
  • Assessment of changes in body weight(Change from Baseline Body Weight at 2 months.)
  • Assessment of changes in bone mass(Change from Baseline Bone Mass at 2 months.)
  • Assessment of changes in Resting Blood Pressure(Change form Baseline Resting Blood Pressure at 2 months.)
  • Assessment of changes in countermovement jump height(Change form Baseline Jump Height at 2 months.)
  • Assessment of changes in Leg Muscle Strength(Change form Baseline Leg Muscle Strength at 2 months.)
  • Assessment of changes in Self-reported Physical Activity Behavior(Change from Baseline Physical Activity Behaviour at 2 months.)
  • Assessment of changes in Visceral Fat(Change from Baseline Visceral Fat at 2 months.)
  • Assessment of changes in Hand Grip Strength(Change form Baseline Hand Grip Strength at 2 months.)
  • Assessment of changes in muscle mass(Change from Baseline Muscle Mass at 2 months.)
  • Assessment of changes in Balance(Change form Baseline balance at 2 months.)

研究者

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

Julie Midtgaard

Associate Professor

Rigshospitalet, Denmark

研究点 (2)

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