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临床试验/NCT03472391
NCT03472391已完成不适用

Physical Therapy for In-patients With Severe Anorexia Nervosa: A Randomized Feasibility Study

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Compliance to overall inpatient treatment.

研究概览

简要总结

In-patients with severe anorexia nervosa (AN) often drop out of treatment, because of ambivalence towards treatment and anxiety for weight gain. However, physical therapy has shown some positive effects on symptoms of AN. This study aims to investigate the feasibility of a randomized control trial (RCT) of a standardized physiotherapeutic program for patients with severe AN with compliance to nutritional therapy as the primary outcome measure.

详细描述

Anorexia nervosa (AN) is a serious and complex disease with unknown etiology. It is characterised by disturbed body image and extreme and devastating fear of gaining weight. The illness leads to a considerable and sometimes dangerous weight loss because of the limited food intake and often an exaggerated exercise behavior. AN can affect people of all ages and of both sexes, but girls or young women are more at risk. The prevalence among young women in Denmark is estimated to be between 0.4% and 1%. AN is associated with a high rate of comorbidity and mortality.

The treatment of AN consist of re-feeding and psychotherapy. Different therapeutic methods and theories have been applied, but none have shown to be superior. The patient alliance and motivation for treatment seem to be essential for a successful treatment. Drop-out is a common challenge. Hence, attention must be directed to how the therapeutic alliance and the patient's motivation can be optimized in order to secure a better treatment effect.

Studies have shown that physical therapy, including supervised exercise and bodily focused interventions, may have a positive effect on symptoms of AN. It may reduce the distorted body image and anxiety. However, it is unknown whether physical therapy can affect compliance and drop out rate to the nutrition therapy. The objective of this study is to investigate the feasibility of a RCT design in this group of patients with severe AN at a specialized unit. The intervention is supervised, standardized physical therapeutic exercises mainly consisting of light strength training. The development of the intervention is based partly on the literature, and partly on interviews and observations with two patients with severe AN.

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
None

入排标准

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

入选标准

  • Patients admitted to the specialized nutrition section at Odense University Hospital and are fulfilling Diagnostic and Statistical Manual (DSM)-5 criteria for AN.
  • 18 years of age or older
  • Patients who can be included within the first two weeks of hospitalization

排除标准

  • Patients who can not fill in a Danish-language questionnaire.
  • Patients who are not able to be in standing position.
  • Patients who are not respiratory and circulatory stable.

研究组 & 干预措施

Intervention

Active Comparator

Supervised exercise therapy by physical therapist: patients allocated to physical therapy will participate in a 4-week (2 sessions a week of 40 minutes) supervised and tailored exercise program mainly consisting of light strength training. The exercise program is an add-on treatment to the primary treatment of re-nutrition and somatic stabilization.

干预措施: Physical Therapy (Behavioral)

Control

No Intervention

The control group follows ordinary treatment in consisting of re-nutrition and somatic stabilization

结局指标

主要结局

Compliance to overall inpatient treatment.

时间窗: 4 weeks

Percentage obtained pre-defined goal weight (0-100%)

次要结局

  • Grip strength(Change from baseline to follow-up (4 weeks))
  • Body Image(Change from baseline to follow-up (4 weeks))
  • Body Mass Index(Change from baseline to follow-up (4 weeks))
  • Quality of Life(Change from baseline to follow-up (4 weeks))
  • Functional Movement(Change from baseline to follow-up (4 weeks))

研究者

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

René Klinkby Støving

Professor

Odense University Hospital

研究点 (2)

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