iT-based Sports Therapy Application in Haemophilia

Sports Physical Therapy Clinical Trial

— iT-BaSTAH  

Official title:

iT-based Sports Therapy Application in Haemophilia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04586101
• Other study ID #: 35318939
• Status: Completed
• Phase: N/A
• Start date: January 31, 2018
• Est. completion date: December 15, 2021

Study information

• Verified date: May 2022
• Source: University of Wuppertal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 15, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Haemophilia
• Hemophilia A
• Sports Physical Therapy

Intervention

Device:
• Trainings application
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.

Locations

Country	Name	City	State
Germany	Department of Sports Medicine, University of Wuppertal	Wuppertal	North Rhine-Westphalia

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Dr. Dr. Thomas Hilberg	Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	bleeding events	number	12 weeks
Other	factor substitution in international units	administered international units of factor VIII or factor IX	12 weeks
Other	frequency of factor substitution	absolute number of substitutions	12 weeks
Primary	frequency of physical activity	absolute number of completed physical activities	12 weeks
Primary	duration of physical activity	mean duration of completed physical activities	12 weeks
Secondary	score of subjective physical performance measured by the HEP-Test-Q	questionnaire	Day 1, 6 and 12 weeks
Secondary	score of subjective quality of life measured by the SF36 Health Survey	questionnaire	Day 1, 6 and 12 weeks
Secondary	pain intensity in score points measured by the German Pain Questionnaire	questionnaire	Day 1, 6 and 12 weeks
Secondary	health-related physical activity presented as metabolic equivalents of tasks	questionnaire	Day 1, 6 and 12 weeks