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临床试验/NCT04586101
NCT04586101已完成不适用

iT-based Sports Therapy Application in Haemophilia

Prof. Dr. Dr. Thomas Hilberg2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
frequency of physical activity

研究概览

简要总结

Haemophilia is often associated with chronic pain, functional restrictions and negative consequences regarding the individual physical performance, especially on basic motoric skills, activities of daily life and quality of life. Caused by high benefits, physical activity is a fixed component and recommendation in the guidelines for the management of haemophilia. Several studies showed that goal-directed physical activity is feasible for patients with haemophilia (PwH) without any complications or bleeding episodes. Nevertheless, there are difficulties in the implementation of supervised sports therapy for PwH regarding local distributions and uncertainties concerning correct exercise execution on patients´ side and in the monitoring and adequate training regulation from long distances on the therapeutic side.

Aim of this project is a patient-related and participative development and pre-evaluation of a mobile application to generate an online-guided, individualized home training for PwH, followed by pre-evaluation in terms of a twelve weeks interventional phase. The intention of this project is to show, that a mobile device is an appropriate way to increase physical activity of PwH. Due to the development of an innovative trainings application, adapted to the needs of PwH, a larger number of patients should be reached and supported later on in participating on supervised physical exercise to improve the individual physical performance and therefore the quality of life. Additionally, with an individualized exercise program also adapted to the specific interests, needs and physical conditions, PwH at any age can be addressed. Furthermore, in cooperation with the patient, the medical staff will get systematic information of patients´ exercise activities to generate optimal factor and overall treatment patterns. In addition, on the basis of the mobile device PwH will be able to comprehend their individual exercise performance and to get an overview of the individual trainings progress and improvements of physical performance with the purpose to enhance the processes of self-motivation. Detailed instructions and information of exercise execution, need of exercise and physical adaptions to be achieved, will minimize complications and support patients´ self-confident for participating on exercise.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

  • patients suffering from moderate to severe haemophilia A or B
  • submitted written consent to participate in the study
  • approved sports capability and internet access

排除标准

  • patients suffering from other bleeding disorders
  • patients without written consent
  • patients under 18 years of age
  • patients without sports capability
  • patients without internet access

结局指标

主要结局

frequency of physical activity

时间窗: 12 weeks

absolute number of completed physical activities

duration of physical activity

时间窗: 12 weeks

mean duration of completed physical activities

次要结局

  • score of subjective physical performance measured by the HEP-Test-Q(Day 1, 6 and 12 weeks)
  • health-related physical activity presented as metabolic equivalents of tasks(Day 1, 6 and 12 weeks)
  • score of subjective quality of life measured by the SF36 Health Survey(Day 1, 6 and 12 weeks)
  • pain intensity in score points measured by the German Pain Questionnaire(Day 1, 6 and 12 weeks)

研究者

发起方
Prof. Dr. Dr. Thomas Hilberg
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Dr. Dr. Thomas Hilberg

Chair holder - chair of sports medicine

University of Wuppertal

研究点 (2)

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