Clinical trial NCT04491318: COVID-19 Quarantine on Musculoskeletal Status in Hemophilia
Official title: Effects of COVID-19 Quarantine on the Musculoskeletal Status of Adult Hemophilia Patients. An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia Arthropathy
Keywords: Hemophilic arthropathy
Joint pain
Joint health
Range of motion
Hemarthrosis
COVID-19
Lead sponsor: Investigación en Hemofilia y Fisioterapia
Sponsor class: NETWORK
First posted: 2020-07-29
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with hemophilic arthropathy routinely treated at the specialized hemophilia center of the Spanish Federation of Hemophilia (Fishemo).

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline frequency of hemarthrosis after confinement period
timeFrame: Screening visit, within the first seven days after confinement
Secondary outcomes:
measure: Change from baseline joint health after confinement period
timeFrame: Screening visit, within the first seven days after confinement
measure: Change from baseline joint pain after confinement period
timeFrame: Screening visit, within the first seven days after confinement
measure: Change from baseline range of motion after confinement period
timeFrame: Screening visit, within the first seven days after confinement
measure: Change from baseline joint pain after confinement period
timeFrame: Screening visit, within the first seven days after confinement
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: European University of Madrid
Study officials:
affiliation: Universidad Europea de Madrid
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References: