iT-based Sports Therapy Application in Haemophilia (iT-BaSTAH)
Primary Purpose
Haemophilia, Sports Physical Therapy
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Trainings application
Sponsored by
About this trial
This is an interventional treatment trial for Haemophilia focused on measuring haemophilia, sports therapy, trainings application, home training
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
Sites / Locations
- Department of Sports Medicine, University of Wuppertal
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Training intervention
Control interverntion
Arm Description
Outcomes
Primary Outcome Measures
frequency of physical activity
absolute number of completed physical activities
duration of physical activity
mean duration of completed physical activities
Secondary Outcome Measures
score of subjective physical performance measured by the HEP-Test-Q
questionnaire
score of subjective quality of life measured by the SF36 Health Survey
questionnaire
pain intensity in score points measured by the German Pain Questionnaire
questionnaire
health-related physical activity presented as metabolic equivalents of tasks
questionnaire
Full Information
NCT ID
NCT04586101
First Posted
July 28, 2020
Last Updated
May 17, 2022
Sponsor
Prof. Dr. Dr. Thomas Hilberg
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT04586101
Brief Title
iT-based Sports Therapy Application in Haemophilia
Acronym
iT-BaSTAH
Official Title
iT-based Sports Therapy Application in Haemophilia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. Dr. Thomas Hilberg
Collaborators
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilia, Sports Physical Therapy
Keywords
haemophilia, sports therapy, trainings application, home training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training intervention
Arm Type
Experimental
Arm Title
Control interverntion
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Trainings application
Intervention Description
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 Outcome Measure Information:
Title
frequency of physical activity
Description
absolute number of completed physical activities
Time Frame
12 weeks
Title
duration of physical activity
Description
mean duration of completed physical activities
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
score of subjective physical performance measured by the HEP-Test-Q
Description
questionnaire
Time Frame
Day 1, 6 and 12 weeks
Title
score of subjective quality of life measured by the SF36 Health Survey
Description
questionnaire
Time Frame
Day 1, 6 and 12 weeks
Title
pain intensity in score points measured by the German Pain Questionnaire
Description
questionnaire
Time Frame
Day 1, 6 and 12 weeks
Title
health-related physical activity presented as metabolic equivalents of tasks
Description
questionnaire
Time Frame
Day 1, 6 and 12 weeks
Other Pre-specified Outcome Measures:
Title
bleeding events
Description
number
Time Frame
12 weeks
Title
factor substitution in international units
Description
administered international units of factor VIII or factor IX
Time Frame
12 weeks
Title
frequency of factor substitution
Description
absolute number of substitutions
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Sports Medicine, University of Wuppertal
City
Wuppertal
State/Province
North Rhine-Westphalia
ZIP/Postal Code
42117
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
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iT-based Sports Therapy Application in Haemophilia
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