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Trial record 1 of 1 for:    NCT04586101
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iT-based Sports Therapy Application in Haemophilia (iT-BaSTAH)

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ClinicalTrials.gov Identifier: NCT04586101
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Prof. Dr. Dr. Thomas Hilberg, University of Wuppertal

Tracking Information
First Submitted Date  ICMJE July 28, 2020
First Posted Date  ICMJE October 14, 2020
Last Update Posted Date October 14, 2020
Actual Study Start Date  ICMJE January 31, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2020)
  • frequency of physical activity [ Time Frame: 12 weeks ]
    absolute number of completed physical activities
  • duration of physical activity [ Time Frame: 12 weeks ]
    mean duration of completed physical activities
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2020)
  • score of subjective physical performance measured by the HEP-Test-Q [ Time Frame: beginning, after 6 and after 12 weeks ]
    questionnaire
  • score of subjective quality of life measured by the SF36 Health Survey [ Time Frame: beginning, after 6 and after 12 weeks ]
    questionnaire
  • pain intensity in score points measured by the German Pain Questionnaire [ Time Frame: beginning, after 6 and after 12 weeks ]
    questionnaire
  • health-related physical activity presented as metabolic equivalents of tasks [ Time Frame: beginning, after 6 and after 12 weeks ]
    questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 6, 2020)
  • bleeding events [ Time Frame: 12 weeks ]
    number
  • factor substitution in international units [ Time Frame: 12 weeks ]
    administered international units of factor VIII or factor IX
  • frequency of factor substitution [ Time Frame: 12 weeks ]
    absolute number of substitutions
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE iT-based Sports Therapy Application in Haemophilia
Official Title  ICMJE iT-based Sports Therapy Application in Haemophilia
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Haemophilia
  • Sports Physical Therapy
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Training intervention
    Intervention: Device: Trainings application
  • No Intervention: Control interverntion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 6, 2020)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04586101
Other Study ID Numbers  ICMJE 35318939
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prof. Dr. Dr. Thomas Hilberg, University of Wuppertal
Study Sponsor  ICMJE Prof. Dr. Dr. Thomas Hilberg
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account University of Wuppertal
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP