iT-based Sports Therapy Application in Haemophilia
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
- 否
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
Prof. Dr. Dr. Thomas Hilberg
Chair holder - chair of sports medicine
University of Wuppertal
