Association Between Individual Clotting Factor Level Monitoring and the Risk of Bleeding Whilst Physical Active Conditions (AIM-Active)

Prof. Dr. Dr. Thomas Hilberg

Status

Unknown

Conditions

Hemophilia A

Treatments

Other: Observation of the association between clotting factor level and risk of bleeding whilst physical activity

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04845555

002286

Details and patient eligibility

About

The aim of this prospective multicentre study is to evaluate the influence of individual clotting factor level while being physically active

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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)