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OpenTrials
Completed

NCT Number: NCT05728528

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

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

Completed

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Key information

Conditions

Hemophilia Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Severe Hemophilia A patients

Exclusion criteria

-

Treatment and study plan

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

Drug

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

pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone

Drug

pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone

Primary outcomes

  1. annualized bleeding rates (ABR)

    Time frame: 6 months

    annualized bleeding rates (ABR)

  2. annualized joint bleeding rates (AJBR)

    Time frame: 6 months

    annualized joint bleeding rates (AJBR)

  3. haemophilia-specific quality-of-life (Haemo-QoL-A) scores

    Time frame: 6 months

    haemophilia-specific quality-of-life (Haemo-QoL-A) scores

  4. hemophilia Joint Health Scores (HJHS)

    Time frame: 6 months

    hemophilia Joint Health Scores (HJHS)

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2023
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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