iT-based Sports Therapy Application in Haemophilia (iT-BaSTAH)

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.

Study Overview

• Status: Completed
• Conditions: Sports Physical Therapy; Haemophilia
• Intervention / Treatment: Device: Trainings application

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • North Rhine-Westphalia
    • Wuppertal, North Rhine-Westphalia, Germany, 42117
      • Department of Sports Medicine, University of Wuppertal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training 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.
No Intervention: Control interverntion

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
bleeding events	number	12 weeks
factor substitution in international units	administered international units of factor VIII or factor IX	12 weeks
frequency of factor substitution	absolute number of substitutions	12 weeks

Collaborators and Investigators

• Sponsor: Prof. Dr. Dr. Thomas Hilberg
• Collaborators: Pfizer

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2018
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): December 15, 2021

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: haemophilia; sports therapy; trainings application; home training
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A
• Other Study ID Numbers: 35318939

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No