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Completed

NCT Number: NCT04586101

iT-based Sports Therapy Application in Haemophilia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Sports Medicine, University of Wuppertal

Wuppertal, North Rhine-Westphalia, 42117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trainings application

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.

Primary outcomes

  1. frequency of physical activity

    Time frame: 12 weeks

    absolute number of completed physical activities

  2. duration of physical activity

    Time frame: 12 weeks

    mean duration of completed physical activities

Secondary outcomes

  1. score of subjective physical performance measured by the HEP-Test-Q

    Time frame: Day 1, 6 and 12 weeks

    questionnaire

  2. score of subjective quality of life measured by the SF36 Health Survey

    Time frame: Day 1, 6 and 12 weeks

    questionnaire

  3. pain intensity in score points measured by the German Pain Questionnaire

    Time frame: Day 1, 6 and 12 weeks

    questionnaire

  4. health-related physical activity presented as metabolic equivalents of tasks

    Time frame: Day 1, 6 and 12 weeks

    questionnaire

Other outcomes

  1. bleeding events

    Time frame: 12 weeks

    number

  2. factor substitution in international units

    Time frame: 12 weeks

    administered international units of factor VIII or factor IX

  3. frequency of factor substitution

    Time frame: 12 weeks

    absolute number of substitutions

Sponsors and collaborators

Lead sponsor

Prof. Dr. Dr. Thomas Hilberg

Other

Collaborators

  • Pfizer

Registry information

Acronym: iT-BaSTAH

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2020
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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