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Completed

NCT Number: NCT05568524

Resistance Training With Blood Flow Restriction in Hemophilia

The main objectives of this study are to evaluate safety and chronic effects of a low-load resistance exercise intervention (elbow flexions and extensions, and knee extensions) with blood flow restriction in people with hemophilia on quality of life, pain, and on physical and neuromuscular function.

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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

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Facultat de Fisioteràpia

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of hemophilia A or B and undergoing prophylaxis;
  • willingness to exercise twice a week during the training program and to complete the pre- and post-program evaluations;
  • approval by their hematologist to participate in the exercise program;
  • age between 18 and 60 years;
  • informed consent signed.

Exclusion criteria

  • the inability to attend exercise sessions at least twice a week for 8 consecutive weeks;
  • non adherence to instruction on proper exercise technique;
  • surgical procedures performed 6 weeks prior to or during the exercise program; - participation in any other form of exercise, not previously done, during the study;
  • changes in medication during the study;
  • a major bleeding episode that posed a risk or prevented exercise;
  • another hemostatic defect;
  • need for major surgery;
  • withdrawal of informed consent.

Treatment and study plan

BFRT

Other

Low-load (30% 1RM) resistance exercise with blood flow restriction

Control

Other

Moderate-to-high load (60%-80% 1RM) resistance exercise

Primary outcomes

  1. HDsEMG

    Time frame: Baseline and week 8.

    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

  2. Hand-held dynamometry (isometric elbow flexion/extension, knee extension)

    Time frame: Baseline and week 8.

    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

  3. Muscle ultrasound (muscle mass, assessment of possible bleedings)

    Time frame: Baseline and week 8.

    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

  4. Digital goniometry for active elbow and knee ROM

    Time frame: Baseline and week 8.

    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

Secondary outcomes

  1. Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)

    Time frame: Baseline and week 8.

    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

  2. Pressure pain thresholds (digital algometry)

    Time frame: Baseline and week 8.

    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

  3. Haemophilia Activities List (HAL) questionnaire

    Time frame: Baseline and week 8.

    The HAL measures the impact of hemophilia on self-perceived functional abilities in adults.

    Its score range is 42-252, with higher scores representing more functional limitations.

  4. A36 haemophilia quality of life (Hemofilia-QoL) questionnaire

    Time frame: Baseline and week 8.

    A36 Hemofilia-QOL is a standardized disease specific questionnaire for the assessment of the health-related quality of life of people with haemophilia. The domains are physical health, daily activities, treatment satisfaction, mental aspects, relationships and social activities. There are 36 items and its score range is 0-144, with higher scores representing better outcomes.

  5. Patient Global Impression of Change Scale (PGICS)

    Time frame: Baseline and week 8.

    On this scale, the patient reflects the perception of the efficacy of the treatment received in their limitation to perform activities, symptoms, emotions and overall quality of life. The PGICS consists of two subscales, one categorical and one quantitative. The categorical scale is a 7-point verbal scale with the options "I have improved a lot" = 7, "I have improved a lot" = 6, "I have improved a little" = 5, "I am the same" = 4, "I have gotten a little worse" = 3, "I have gotten a lot worse" = 2, "I have gotten a lot worse" = 1. Meanwhile, the quantitative scale consists of a line from 0 to 10, where 0 = much better and 10 = much worse.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

The Acute and Chronic Impact of Blood Flow Restriction Resistance Training on Physical and Neuromuscular Function, Pain, and Quality of Life in Patients With Moderate/Severe Hemophilia

Acronym: HemoBFR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 5, 2022
Registry last updated
Feb 3, 2026

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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