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Completed

NCT Number: NCT05039008

Restricting Blood Flow in Improving Muscle Strength in Patients With Hemophilic Arthropathy

Background. The main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy.

Objective. To assess the safety and effectiveness of an intervention through blood flow restriction, regarding the frequency of bleeding and the improvement in the perception of muscle activation and strength, functionality, joint pain, joint status and the perception of quality of life in patients with hemophilic arthropathy. knee and ankle.

Study design. Randomized, multicenter, single-blind clinical study. Method. 20patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 3 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and range of motion (goniometer). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 4 weeks.

Expected results. Observe the safety of blood flow restriction in hemophilia patients. To analyze the efficacy of blood flow restriction in improving muscle strength, joint pain, range of motion, and joint damage in patients with hemophilic knee and ankle arthropathy.

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Key information

Conditions

Hemophilia Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Chronic Pain Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rubén Cuesta-Barriuso

Oviedo, Principality of Asturias, 33006, Spain

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients diagnosed with hemophilia A and B
  • Patients with a medical diagnosis of hemophilic ankle and knee arthropathy
  • People over 18 years of age
  • Patients on prophylactic or on-demand treatment regimen with FVIII / FIX concentrates

Exclusion criteria

  • Patients with neurological or cognitive disorders that impede understanding of the test.
  • Pain free patients
  • Amputees, epileptics or patients with severe vision problems
  • Patients who are receiving Physiotherapy treatment at the time of the study
  • Patients who have not signed the informed consent document

Treatment and study plan

Blood Flow Restriction

Other

The intervention protocol will be carried out under the same environmental conditions and, as far as possible, at the same time. The intervention will last 4 weeks, with a periodicity of 3 weekly sessions. In total there will be 12 sessions that will last between 15 and 30 minutes depending on the number of joints affected.

Primary outcomes

  1. Change from baseline hemarthrosis after treatment and at four weeks.

    Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit

    A self-registration will be used to evaluate the frequency of bleeding, and thus the safety of the technique. This self-registration will be given to each patient at the beginning of the study and they must fill in the number of hemarthrosis and their main characteristics: date, origin (traumatic or spontaneous) and location (knee or ankle). The self-registration will be delivered to the evaluator in each of the study evaluations (post-treatment and follow-up).

Secondary outcomes

  1. Change from baseline joint pain after treatment and at four weeks

    Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit

    The visual analog scale will be used to assess the perception of joint pain, being valued with a range of 0 to 10 points (from no pain to the maximum pain suffered or imaginable) in the joints evaluated

  2. Change from baseline muscle strength after treatment and at four weeks

    Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit

    With a pressure dynamometer (microFET®2 Digital Handheld model) we will measure the strength of the quadriceps and triceps surae. This device measures in Newton the force that the patient exerts in the requested muscular action. The higher the value, the greater the muscle strength. We will carry out the measurements bilaterally. The patient will be asked 4 maximum isometric contractions of 5 seconds, with a rest of 30 seconds between them, against the dynamometer located in the hand of the evaluator

  3. Change from baseline joint status after treatment and at four weeks

    Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit

    Change from knee and ankle joint status during treatment and follow-up period at four weeks. Measurement instrument: Haemophilia Joint Health Score (scale 0-20).

  4. Change from baseline range of motion after treatment and at four weeks

    Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit

    Change from range of movement of knee and ankle during treatment and follow-up period at four weeks. The range of motion of the knee and ankle joint will be measured using a universal goniometer, using the protocol for measuring joint motion described by the American Academy of Orthopaedic Surgeons.

Sponsors and collaborators

Lead sponsor

Investigación en Hemofilia y Fisioterapia

Network

Registry information

Official study title

Effectiveness of Physiotherapy Intervention by Restricting Blood Flow in Improving Muscle Strength in Patients With Hemophilic Arthropathy. Randomized Multicenter Clinical Study.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 9, 2021
Registry last updated
Feb 9, 2024

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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