Clinical trial NCT04845555: Association Between Individual Clotting Factor Level Monitoring and the Risk of Bleeding Whilst Physical Active Conditions
Official title: Association Between Individual Clotting Factor Level Monitoring and the Risk of Bleeding Whilst Physical Active Conditions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemophilia A
Keywords: Hemophilia A
Clotting Factor Level
Exercise
Pharmacokinetics
Physical activity
Lead sponsor: University of Wuppertal
Sponsor class: OTHER
Collaborators: name: Takeda
name: University of Bonn
First posted: 2021-04-15
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from hemophilia A recruited by cooperating hemophilic treatment centers.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* patients suffering from moderate or severe hemophilia A (FVIII \<5%, ≥ 12 years old)
* factor treatment with ADVATE© or ADYNOVI©
* use of myPKFiT

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Type of physical activity documented in a digital template
timeFrame: 12 months
measure: Physiological parameters (heart rate of PwH, measured with FitBit Charge 4 HR)
timeFrame: 12 months
measure: Total annual bleeding rate
timeFrame: 12 months
measure: Clotting factor VIII level
timeFrame: 12 months
Secondary outcomes:
measure: Factor substitution in international units
timeFrame: 12 months
measure: Frequency of factor substitution
timeFrame: 12 months
measure: Score of subjective quality of life measured by the SF36 Health Survey
timeFrame: Baseline, after 6 and 12 months
measure: Joint status in score points measured by Hemophilia Joint Health Score
timeFrame: Baseline, after 6 and 12 months
measure: Pain status measured by the German Pain Questionnaire
timeFrame: Baseline, after 6 and 12 months
measure: Pressure pain thresholds
timeFrame: Baseline, after 6 and 12 months
measure: Score of subjective physical performance measured by the HEP-Test-Q
timeFrame: Baseline, after 6 and 12 months
Other outcomes:
Locations:
city: Wuppertal
country: Germany
facility: Department of Sports Medicine, University of Wuppertal
state: North Rhine-Westphalia
Study officials:
affiliation: Head of Department of sports medicine Wuppertal
name: Thomas Hilberg, Prof.
role: STUDY_CHAIR
References: