iT-based Sports Therapy Application in Haemophilia

Study Overview
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Brief Summary
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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.

Official Title
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iT-based Sports Therapy Application in Haemophilia

Conditions
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Haemophilia, Sports Physical Therapy

Intervention / Treatment
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* Device: Trainings application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients suffering from moderate to severe haemophilia A or B submitted written consent to participate in the study approved sports capability and internet access Exclusion Criteria: patients suffering from other bleeding disorders patients without written consent patients under 18 years of age patients without sports capability patients without internet access

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training intervention<br> | Device: Trainings application<br>* Participants have to train with the developed trainings application over six weeks. For this, individual training plans are implemented in the application based on orthopedic joint status and training recommendations of a sports scientist.<br>|
| No Intervention: Control interverntion<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of physical activity | absolute number of completed physical activities | 12 weeks | 
| duration of physical activity | mean duration of completed physical activities | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score of subjective physical performance measured by the HEP-Test-Q | questionnaire | Day 1, 6 and 12 weeks | 
| score of subjective quality of life measured by the SF36 Health Survey | questionnaire | Day 1, 6 and 12 weeks | 
| pain intensity in score points measured by the German Pain Questionnaire | questionnaire | Day 1, 6 and 12 weeks | 
| health-related physical activity presented as metabolic equivalents of tasks | questionnaire | Day 1, 6 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sports therapy, trainings application, home training, haemophilia