Hemophilia AAIM-ActiveNCT04845555
Association Between Individual Clotting Factor Level Monitoring and the Risk of Bleeding Whilst Physical Active Conditions
An observational study of Hemophilia A, run by Prof. Dr. Dr. Thomas Hilberg at 1 site in Germany.
Trial summary
The aim of this prospective multicentre study is to evaluate the influence of individual clotting factor level while being physically active Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Observation of the association between clotting factor level and risk of bleeding whilst physical activity
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2019to 30 Dec 2022
- Phase
- Observational
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients suffering from hemophilia A recruited by cooperating hemophilic treatment centers.
Who may be able to join
- patients suffering from moderate or severe hemophilia A (FVIII <5%, ≥ 12 years old)
- factor treatment with ADVATE© or ADYNOVI©
- use of myPKFiT
Who cannot join
- patients suffering from other coagulopathies
- participants without written consent
- participants < 12 years old
- joint surgery like arthroscopy, synovectomy up to six months before study
- suffering from different rheumatologic diseases like M. Bechterew, Psoriasi or other local or generalized joint infections (Borreliosis, septic arthritis)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Sports Medicine, University of Wuppertal
Wuppertal, North Rhine-Westphalia, 42117
Thomas Hilberg, Prof., 004920237320812, sportmedizin@uni-wuppertal.de
About this study
The aim of this prospective multicentre study is to evaluate the influence of individual clotting factor level while being physically active
Read the detailed description
In patients with haemophilia (PwH) repetitive joint bleedings result in a so called haemophilic arthropathy, which is often associated with chronic pain as well as functional restrictions.
Due to the opportunity of sufficient factor treatment regimes, physical activity is no longer considered as a risk factor for PwH. In contrast, the large amount of current scientific evidence demonstrated high benefits of regular exercising for PwH. Meanwhile, physical activity is integrated as recommendation in the ´Guidelines for the management of hemophilia´. Nevertheless, the detailed influence of the exact course of the individual clotting factor level corresponding to the intensity of physical activities in consideration of possible bleeding events in adult PwH have not been examined to date.
The aim of this prospective multicentre study is to evaluate the influence of individual clotting factor level while being physically activie. Hereby the focus is on haemophilic specific parameters such as bleeding events, factor treatment and pain. On the basis of this study, an individualized clotting factor level should be determined which ensures a minimized risk of a bleeding event, considering type and intensity of the exercises. In line with these new findings, further interventional studies could be initiated in order to safely enhance the degraded physical performance as well as quality of life in PwH.
The generated knowledge could be further used in the development of haemophilic specific recommendations regarding physical activity in consideration of the individual clotting factor level.
- Conditions
- Hemophilia A
- Being tested
- Observation of the association between clotting factor level and risk of bleeding whilst physical activity
- Keywords
- Hemophilia A, Clotting Factor Level, Exercise, Pharmacokinetics, Physical activity
- Medical subject headings
- Hemophilia A, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of the association between clotting factor level and risk of bleeding whilst physical activityOther
The participants of this study will be monitored for a period of twelve months regarding individual clotting factor level, bleeding episodes as well as type and intensity of physical activity. By doing so, bleeding events, factor consumption as well as the course of the individual factor clotting factor level will be documented via the mobile application "myPKFiT". This individual factor treatment regime will be compared with the retrospective treatment outcome in the last twelve months before the first study visit.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hemophilia A | Patients suffering from moderate or severe hemophilia A (FVIII <5%) over the age of 12 years. Receives: Other: Observation of the association between clotting factor level and risk of bleeding whilst physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of physical activity documented in a digital template
PwH are used to document the type and intensity of their physical activity in terms of a digital template which will be electronically requested monthly by co-workers of this study
Measured: 12 months
Physiological parameters (heart rate of PwH, measured with FitBit Charge 4 HR)
Individual type and intensity of physical activity measured as heart rate by an electronic activity wristband (Fitbit charge 4 HR, synchronized in corresponding FitBit Application) For the final evaluation, each physical activity will be clustered regarding type and intensity to differ between the specific demands of activity.
Measured: 12 months
Total annual bleeding rate
Number of bleedings per year, documented in a digital template
Measured: 12 months
Clotting factor VIII level
In percent, documented in "myPKFIT"
Measured: 12 months
Secondary outcomes (7)
Factor substitution in international units
Administered international units of factor VIII
Measured: 12 months
Frequency of factor substitution
Frequency and units of factor replacement
Measured: 12 months
Score of subjective quality of life measured by the SF36 Health Survey
Questionnaire: The possible score ranges from 0 to 100 points. 0 points represent the greatest possible restriction of health, while 100 points represent the absence of health restrictions
Measured: Baseline, after 6 and 12 months
Joint status in score points measured by Hemophilia Joint Health Score
The clinical joint situation will be examined in all PwH and controls by the Haemophilia Joint Health Score, which assesses, e.g., swelling, muscle atrophy, crepitus on motion, axial deformity and range of motion. Higher score points imply an increased deficit in the functional and structural joint status as a sign of more pronounced haemophilic arthropathy, with a maximum possible value of 26 score points for knee and ankle joints and a maximum of 20 score points for elbow joints
Measured: Baseline, after 6 and 12 months
Pain status measured by the German Pain Questionnaire
Questionnaire includes: Demographic data (age, sex, body weight, height); detailed subjective description of pain (localization, characteristics, time course, intensity, etc.); assessment of pain-relieving and pain-enhancing conditions, subjective pain perception (the pain description list SBL); pain-related impairment (also valid for Von Korff grading); subjective pain model, causal attribution, relieving or enhancing factors; screening of depressive and anxiety disorders (Depression, Anxiety and Stress Scale, DASS). Screening of depressive and anxious disorders (Depression, Anxiety and Stress Scale, DASS); General well-being (Marburg Questionnaire on Habitual Well-being, MFHW); Course of disease (extent of previous treatment, physicians consulted for pain, use of medication, pain therapy treatment procedures, operations); Medical and psychological/psychiatric comorbidity
Measured: Baseline, after 6 and 12 months
Pressure pain thresholds
Pressure pain thresholds will be examined by using a digital algometer device (FPX 25 Compact Digital Algom-eter, Wagner Instruments, Greenwich, CT, USA) with a robe area of 1 cm2. Pressure is increased by a rate of 10 Newton/second. It is a measuring method to analyze the current pain condition. Participants are instructed to report the moment when the stimulus becomes painful for the first time. The maximum pressure is 140 N to avoid tissue damages. The mean value of three measurements will be used as pressure pain thresholds for further statistical analyses. Pressure pain thresholds of knee, ankle, elbow, sternum and forehead (the last two being the reference points) will be examined.
Measured: Baseline, after 6 and 12 months
Score of subjective physical performance measured by the HEP-Test-Q
Questionnaire of subjective physical functioning for patients with hemophilia.The HEP Test-Q consists of 25 items belonging to 4 dimensions 'flexibility', 'strength \& coordination', 'endurance' and 'body perception' and a single item that measures changes in physical functioning compared to the previous year. Subscales and total score are transformed to a 0-100 scale, with high scores representing better physical functioning.
Measured: Baseline, after 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Sep 2019
- Primary completion1 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Dr. Thomas Hilberg
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda, University of Bonn
- Responsible party
- Sponsor-investigator, Prof. Dr. Dr. Thomas Hilberg, University of Wuppertal
- Investigators
- Thomas Hilberg, Prof., Study chair, Head of Department of sports medicine Wuppertal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845555
- Sponsor's protocol ID
- 002286
- Acronym
- AIM-Active
- Status last verified
- May 2022
- First submitted
- 28 Jul 2020
- Last updated
- 18 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 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Individual Clotting Factor Level Monitoring and the Risk of Bleeding Whilst Physical Active Conditions
- ClinicalTrials.gov ID
- NCT04845555
- Acronym / sponsor ID
- AIM-Active / 002286
- Conditions
- Hemophilia A
- Keywords
- Hemophilia A, Clotting Factor Level, Exercise, Pharmacokinetics, Physical activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Prof. Dr. Dr. Thomas HilbergUniversity, hospital or other
- Collaborators
- Takeda, University of Bonn
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 15 Apr 2021 (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.
The aim of this prospective multicentre study is to evaluate the influence of individual clotting factor level while being physically active
Detailed description
In patients with haemophilia (PwH) repetitive joint bleedings result in a so called haemophilic arthropathy, which is often associated with chronic pain as well as functional restrictions.
Due to the opportunity of sufficient factor treatment regimes, physical activity is no longer considered as a risk factor for PwH. In contrast, the large amount of current scientific evidence demonstrated high benefits of regular exercising for PwH. Meanwhile, physical activity is integrated as recommendation in the ´Guidelines for the management of hemophilia´. Nevertheless, the detailed influence of the exact course of the individual clotting factor level corresponding to the intensity of physical activities in consideration of possible bleeding events in adult PwH have not been examined to date.
The aim of this prospective multicentre study is to evaluate the influence of individual clotting factor level while being physically activie. Hereby the focus is on haemophilic specific parameters such as bleeding events, factor treatment and pain. On the basis of this study, an individualized clotting factor level should be determined which ensures a minimized risk of a bleeding event, considering type and intensity of the exercises. In line with these new findings, further interventional studies could be initiated in order to safely enhance the degraded physical performance as well as quality of life in PwH.
The generated knowledge could be further used in the development of haemophilic specific recommendations regarding physical activity in consideration of the individual clotting factor level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hemophilia A | – | Other: Observation of the association between clotting factor level and risk of bleeding whilst physical activityPatients suffering from moderate or severe hemophilia A (FVIII <5%) over the age of 12 years. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suffering from hemophilia A recruited by cooperating hemophilic treatment centers.
Key inclusion criteria (3 listed)
- patients suffering from moderate or severe hemophilia A (FVIII <5%, ≥ 12 years old)
- factor treatment with ADVATE© or ADYNOVI©
- use of myPKFiT
Key exclusion criteria (5 listed)
- patients suffering from other coagulopathies
- participants without written consent
- participants < 12 years old
- joint surgery like arthroscopy, synovectomy up to six months before study
- suffering from different rheumatologic diseases like M. Bechterew, Psoriasi or other local or generalized joint infections (Borreliosis, septic arthritis)
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 |
|---|---|---|
| Observation of the association between clotting factor level and risk of bleeding whilst physical activityThe participants of this study will be monitored for a period of twelve months regarding individual clotting factor level, bleeding episodes as well as type and intensity of physical activity. By doing so, bleeding events, factor consumption as well as the course of the individual factor clotting factor level will be documented via the mobile application "myPKFiT". This individual factor treatment regime will be compared with the retrospective treatment outcome in the last twelve months before the first study visit. | Other | Patients with hemophilia A |
Primary outcome
Type of physical activity documented in a digital template
Time frame: 12 months
PwH are used to document the type and intensity of their physical activity in terms of a digital template which will be electronically requested monthly by co-workers of this study
Physiological parameters (heart rate of PwH, measured with FitBit Charge 4 HR)
Time frame: 12 months
Individual type and intensity of physical activity measured as heart rate by an electronic activity wristband (Fitbit charge 4 HR, synchronized in corresponding FitBit Application) For the final evaluation, each physical activity will be clustered regarding type and intensity to differ between the specific demands of activity.
Total annual bleeding rate
Time frame: 12 months
Number of bleedings per year, documented in a digital template
Clotting factor VIII level
Time frame: 12 months
In percent, documented in "myPKFIT"
7 secondary outcomes
Factor substitution in international units
Time frame: 12 months
Frequency of factor substitution
Time frame: 12 months
Score of subjective quality of life measured by the SF36 Health Survey
Time frame: Baseline, after 6 and 12 months
Joint status in score points measured by Hemophilia Joint Health Score
Time frame: Baseline, after 6 and 12 months
Pain status measured by the German Pain Questionnaire
Time frame: Baseline, after 6 and 12 months
Pressure pain thresholds
Time frame: Baseline, after 6 and 12 months
Score of subjective physical performance measured by the HEP-Test-Q
Time frame: Baseline, after 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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.
Thomas Hilberg, Prof. study chair
Head of Department of sports medicine Wuppertal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A, 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: status not confirmed, as of the sponsor's last update on 18 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Hilberg, Prof. (0202-373-208-12, hilberg@uni-wuppertal.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of physical activity documented in a digital template (time frame: 12 months). The study lists 4 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 18 May 2022.