COVID-19 Quarantine on Musculoskeletal Status in Hemophilia

NCT ID: NCT04491318

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2020-07-29

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.

Conditions

Hemophilia Arthropathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental group

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.

Observational

Intervention Type: OTHER

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.

Interventions

Observational

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Investigación en Hemofilia y Fisioterapia

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rubén Cuesta-Barriuso, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Europea de Madrid

Locations

European University of Madrid

Madrid, , Spain

Countries

Spain

Other Identifiers

HemoCov

Identifier Type: -

Identifier Source: org_study_id