NCT04586101: iT-BaSTAH

iT-based Sports Therapy Application in Haemophilia

Completed NA Last updated 25 May 2022

What this trial tests

NA trial testing Trainings application in Haemophilia in 20 participants. Completed in 15 December 2021.

Timeline

31 January 2018

Primary endpoint
15 December 2021

15 December 2021

Quick facts

Lead sponsor	Prof. Dr. Dr. Thomas Hilberg
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	31 January 2018
Primary completion	15 December 2021
Estimated completion	15 December 2021
Sites	1 location across Germany

Drugs / interventions tested

• Trainings application

Conditions studied

• Haemophilia — all drugs for Haemophilia →
• Sports Physical Therapy — all drugs for Sports Physical Therapy →

Sponsor

Prof. Dr. Dr. Thomas Hilberg

Who can join

Adults 18 to 65, any sex, with Haemophilia or Sports Physical Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.