Clinical trial NCT04586101: iT-based Sports Therapy Application in Haemophilia
Official title: iT-based Sports Therapy Application in Haemophilia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Haemophilia
Sports Physical Therapy
Keywords: haemophilia
sports therapy
trainings application
home training
Lead sponsor: University of Wuppertal
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2020-10-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: frequency of physical activity
timeFrame: 12 weeks
measure: duration of physical activity
timeFrame: 12 weeks
Secondary outcomes:
measure: score of subjective physical performance measured by the HEP-Test-Q
timeFrame: Day 1, 6 and 12 weeks
measure: score of subjective quality of life measured by the SF36 Health Survey
timeFrame: Day 1, 6 and 12 weeks
measure: pain intensity in score points measured by the German Pain Questionnaire
timeFrame: Day 1, 6 and 12 weeks
measure: health-related physical activity presented as metabolic equivalents of tasks
timeFrame: Day 1, 6 and 12 weeks
Other outcomes:
measure: bleeding events
timeFrame: 12 weeks
measure: factor substitution in international units
timeFrame: 12 weeks
measure: frequency of factor substitution
timeFrame: 12 weeks
Locations:
city: Wuppertal
country: Germany
facility: Department of Sports Medicine, University of Wuppertal
state: North Rhine-Westphalia
Study officials:
References: