Impact of Moderate Intensity Physical Activities on PK-guided EHL FVIII Concentrates Prophylaxis Severe HA Patients

Study Overview
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Brief Summary
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To compare clinical outcomes before and after using combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis in moderate to severe hemophilia A patients

Detailed Description
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This is a prospective cohort study of severe hemophilia A patients receiving low-dose EHL FVIII concentrates with PK-guided EHL FVIII concentrates prophylaxis alone for 6 months. Additional exercise workshops from sport scientists were introduced individually to this group of patients along with using the same prophylaxis method for another period of 6 months. The annualized bleeding rates (ABR), the annualized joint bleeding rates (AJBR), the haemophilia-specific quality-of-life (Haemo-QoL-A) scores, the hemophilia Joint Health Scores (HJHS) and skeletal muscle mass were compared between these two periods

Official Title
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Impact of Moderate to Vigorous-intensity Physical Activities on Pharmacokinetic-guided Extended Half-life FVIII Concentrates Prophylaxis Severe Hemophilia A Patients

Conditions
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Hemophilia

Intervention / Treatment
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* Drug: combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis
* Drug: pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe Hemophilia A patients Exclusion Criteria: -
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PK-guided EHL FVIII concentrates prophylaxis with moderate intensity physical activities<br>PK-guided EHL FVIII concentrates prophylaxis with moderate intensity physical activities | Drug: combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis<br>* combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis<br>|
| Active Comparator: PK-guided EHL FVIII concentrates prophylaxis alone<br>PK-guided EHL FVIII concentrates prophylaxis alone | Drug: pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone<br>* pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| annualized bleeding rates (ABR) | annualized bleeding rates (ABR) | 6 months | 
| annualized joint bleeding rates (AJBR) | annualized joint bleeding rates (AJBR) | 6 months | 
| haemophilia-specific quality-of-life (Haemo-QoL-A) scores | haemophilia-specific quality-of-life (Haemo-QoL-A) scores | 6 months | 
| hemophilia Joint Health Scores (HJHS) | hemophilia Joint Health Scores (HJHS) | 6 months |