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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05728528
Enrollment
13
Registered
2023-02-15
Start date
2022-07-01
Completion date
2022-12-31
Last updated
2023-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia

Brief summary

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

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

Interventions

DRUGcombination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis

combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis

DRUGpharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone

pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

Inclusion criteria

* Severe Hemophilia A patients

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
annualized bleeding rates (ABR)6 monthsannualized bleeding rates (ABR)
annualized joint bleeding rates (AJBR)6 monthsannualized joint bleeding rates (AJBR)
haemophilia-specific quality-of-life (Haemo-QoL-A) scores6 monthshaemophilia-specific quality-of-life (Haemo-QoL-A) scores
hemophilia Joint Health Scores (HJHS)6 monthshemophilia Joint Health Scores (HJHS)

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026