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临床试验/NCT05608863
NCT05608863进行中(未招募)不适用

He-move-philia, a Combined Lifestyle Intervention Program for Patients With Hemophilia and Other Bleeding Disorders

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11月2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)
入组人数
30
试验地点
2
主要终点
kg

研究概览

简要总结

The main objectives are reduction of body weight, BMI and abdominal circumference. Secondary objectives are reduction of bleeds and units coagulation factor concentrate used, blood-pressure, cholesterol spectrum, glucose and improvement of physical activity and dietary habits. one group of patients will receive a combined lifestyle intervention program with individual sessions and group sessions lasting for 2 years, the other group of patients will receive individual sessions only and will be given the same information as given in the group sessions, but on paper.

详细描述

The prevalence of overweight and obesity is increasing in patients with hemophilia and other bleeding disorders. In these patients physical activity is often difficult due to arthropathy as a result of intra-articular bleeding in the past, with decreased joint movement and pain and the fear of new bleeds. This enhances weight gain, increases pressure on joints, leading to more bleeds and more arthropathy. In the long term overweight and obesity increases risk of cardiovascular diseases, with the concomitant need for anticoagulant therapy, which further enhances the bleeding risk in these patients. The aim of this exploratory study is to compare the effect of a lifestyle intervention program consisting of combined individual coaching and group sessions (CLI) with a lifestyle intervention program with individual coaching only (II).The program is especially designed for patients with a bleeding disorder. The investigators hypothesize that body weight, BMI, abdominal circumference, bleeds and units coagulation factor concentrate, as these are dosed on body weight, will decrease in both groups, but more in the CLI with group sessions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

kg

时间窗: 36 months

The main study parameter is body weight in kg.

次要结局

  • Haemophilia activities of daily life (HAL)(36 months)
  • Abdominal circumference (cm)(36 months)
  • Number of spontaneous bleeds(36 months)
  • Units coagulation factor concentrate used/year (IU)(36 months)
  • Number of induced bleeds(36 months)
  • Shortened Fat List(36 months)
  • Blood-pressurre (mm Hg)(36 months)
  • Cholesterol spectrum(36 months)
  • Glucose (mmol/l)(36 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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