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 |
|