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COVID-19 Quarantine on Musculoskeletal Status in Hemophilia (HemoCov)

I

Investigación en Hemofilia y Fisioterapia

Status

Completed

Conditions

Hemophilia Arthropathy

Treatments

Other: Observational

Study type

Observational

Funder types

NETWORK

Identifiers

NCT04491318
HemoCov

Details and patient eligibility

About

Background. The recurrence of hemarthrosis in patients with congenital coagulopathies favors the development of a progressive, degenerative and intra-articular lesion (hemophilic arthropathy) that mainly affects the knees, ankles and elbows. Pain is one of the main clinical manifestations of hemophilic arthropathy. As a consequence of the COVID-19 pandemic, the Government of Spain, among others, established a total confinement for two months, in order to avoid contagion of the population Objective. To assess the effect of COVID-19 confinement on bleeding frequency, pain perception, and range of motion in patients with hemophilic arthropathy.

Study design. Prospective observational study. Method. 27 patients with hemophilia A and B will be included in this study. Patients will be recruited from the Spanish Hemophilia Federation (Fishemo) specialized center for hemophilia patients. The dependent variables will be: the frequency of bleeding (through a self-report), the perception of pain (measured with the visual analog scale and a pressure algometer), the joint state (with the Hemophilia Joint Health Score), and the range of joint movement (measured with a goniometer). Two evaluations will be carried out: pre-treatment (carried out in the month of February, as a periodic evaluation) and post-treatment (at the end of the period of confinement in Spain).

Expected results. The aim is to observe the sequelae caused by confinement and a sedentary lifestyle in patients with hemophilic arthropathy, through changes in joint status, pain and range of motion.

Enrollment

27 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients with medical diagnosis of hemophilia A or hemophilia B
  • Patients over 18 years of age
  • Patients in a prophylactic or on demand regimen with factor VIII / factor IX concentrates
  • Patients that have accepted the informed consent document.

Exclusion criteria

  • Patients with neurological or cognitive disorders that prevent the comprehension of the questionnaires
  • Patients without capacity to walk autonomously or with orthosis
  • Patients without access to digital media to complement the measuring instruments.

Trial design

27 participants in 1 patient group

Experimental group
Description:
Hemophilic arthropathy patients who will not receive any intervention. The dependent variables (frequency of hemarthrosis, pain, joint state and range of movement) in the joints will be evaluated: elbows, knees and ankles.
Treatment:
Other: Observational

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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