iT-based Sports Therapy Application in Haemophilia

NCT ID: NCT04586101

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-31
• Study Completion Date: 2021-12-15

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.

Conditions

Haemophilia; Sports Physical Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Training intervention

Group Type: EXPERIMENTAL

Trainings application

Intervention Type: DEVICE

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.

Control interverntion

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Prof. Dr. Dr. Thomas Hilberg

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Dr. Thomas Hilberg

Chair holder - chair of sports medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Sports Medicine, University of Wuppertal

Wuppertal, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

35318939

Identifier Type: -

Identifier Source: org_study_id