HaemophiliaiT-BaSTAHNCT04586101
iT-based Sports Therapy Application in Haemophilia
A study testing Trainings application in people with Haemophilia and Sports Physical Therapy, run by Prof. Dr. Dr. Thomas Hilberg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Haemophilia, Sports Physical Therapy
- What is being tested?
- Trainings application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jan 2018to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients suffering from moderate to severe haemophilia A or B
- submitted written consent to participate in the study
- approved sports capability and internet access
Who cannot join
- patients suffering from other bleeding disorders
- patients without written consent
- patients under 18 years of age
- patients without sports capability
- patients without internet access
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Sports Medicine, University of Wuppertal
Wuppertal, North Rhine-Westphalia, 42117
About this study
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
- Being tested
- Trainings application
- Keywords
- haemophilia, sports therapy, trainings application, home training
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trainings applicationDevice
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 group | Role | What they receive |
|---|---|---|
| Training intervention | Experimental | Not described Receives: Device: Trainings application |
| Control interverntion | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of physical activity
absolute number of completed physical activities
Measured: 12 weeks
duration of physical activity
mean duration of completed physical activities
Measured: 12 weeks
Secondary outcomes (4)
score of subjective physical performance measured by the HEP-Test-Q
questionnaire
Measured: Day 1, 6 and 12 weeks
score of subjective quality of life measured by the SF36 Health Survey
questionnaire
Measured: Day 1, 6 and 12 weeks
pain intensity in score points measured by the German Pain Questionnaire
questionnaire
Measured: Day 1, 6 and 12 weeks
health-related physical activity presented as metabolic equivalents of tasks
questionnaire
Measured: Day 1, 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start31 Jan 2018
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Dr. Thomas Hilberg
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor-investigator, Prof. Dr. Dr. Thomas Hilberg, University of Wuppertal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586101
- Sponsor's protocol ID
- 35318939
- Acronym
- iT-BaSTAH
- Status last verified
- May 2022
- First submitted
- 28 Jul 2020
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iT-based Sports Therapy Application in Haemophilia
- ClinicalTrials.gov ID
- NCT04586101
- Acronym / sponsor ID
- iT-BaSTAH / 35318939
- Conditions
- Haemophilia, Sports Physical Therapy
- Keywords
- haemophilia, sports therapy, trainings application, home training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Prof. Dr. Dr. Thomas HilbergUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training intervention | Experimental | Device: Trainings application |
| Control interverntion | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients suffering from moderate to severe haemophilia A or B
- submitted written consent to participate in the study
- approved sports capability and internet access
Key exclusion criteria (5 listed)
- patients suffering from other bleeding disorders
- patients without written consent
- patients under 18 years of age
- patients without sports capability
- patients without internet access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trainings applicationParticipants 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. | Device | Training intervention |
Primary outcome
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
4 secondary outcomes
score of subjective physical performance measured by the HEP-Test-Q
Time frame: Day 1, 6 and 12 weeks
score of subjective quality of life measured by the SF36 Health Survey
Time frame: Day 1, 6 and 12 weeks
pain intensity in score points measured by the German Pain Questionnaire
Time frame: Day 1, 6 and 12 weeks
health-related physical activity presented as metabolic equivalents of tasks
Time frame: Day 1, 6 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trainings application in people with Haemophilia and Sports Physical Therapy, run by Prof. Dr. Dr. Thomas Hilberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of physical activity (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.