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

Hemophilia A Clinical Trial

— AIM-Active  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04845555
• Other study ID #: 002286
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2022
• Source: University of Wuppertal
• Contact: Thomas Hilberg, Prof.
• Phone: 0202-373-208-12
• Email: hilberg[@]uni-wuppertal.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hemophilia A

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Sports Medicine, University of Wuppertal	Wuppertal	North Rhine-Westphalia

Sponsors (3)

Lead Sponsor	Collaborator
Prof. Dr. Dr. Thomas Hilberg	Takeda, University of Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Primary	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.	12 months
Primary	Total annual bleeding rate	Number of bleedings per year, documented in a digital template	12 months
Primary	Clotting factor VIII level	In percent, documented in "myPKFIT"	12 months
Secondary	Factor substitution in international units	Administered international units of factor VIII	12 months
Secondary	Frequency of factor substitution	Frequency and units of factor replacement	12 months
Secondary	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	Baseline, after 6 and 12 months
Secondary	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	Baseline, after 6 and 12 months
Secondary	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	Baseline, after 6 and 12 months
Secondary	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.	Baseline, after 6 and 12 months
Secondary	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.	Baseline, after 6 and 12 months