COVID-19 Quarantine on Musculoskeletal Status in Hemophilia

NCT04491318 | Completed

• 1 other identifier: HemoCov
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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

Keywords

Hemophilic arthropathy; Joint pain; Joint health; Range of motion; Hemarthrosis; COVID-19

Outcome Measures

Primary Outcomes (1)

• Change from baseline frequency of hemarthrosis after confinement period

  The frequency of joint bleeding was assessed using a self-assessment log provided to patients at the beginning of confinement electronically. This registry included a monthly calendar where the patients included the date, symptoms and location of the hemarthrosis.

  Screening visit, within the first seven days after confinement

Secondary Outcomes (4)

• Change from baseline joint health after confinement period

  Screening visit, within the first seven days after confinement

• Change from baseline joint pain after confinement period

  Screening visit, within the first seven days after confinement

• Change from baseline range of motion after confinement period

  Screening visit, within the first seven days after confinement

• Change from baseline joint pain after confinement period

  Screening visit, within the first seven days after confinement

Study Arms (1)

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.

Other: Observational

Interventions

Observational 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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead

Study Sites (1)

European University of Madrid

Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Arthralgia; Hemarthrosis; COVID-19

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hemorrhage; Pathologic Processes; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Rubén Cuesta-Barriuso, PhD

  Universidad Europea de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 29, 2020
• Study Start: July 1, 2020
• Primary Completion: July 25, 2020
• Study Completion: July 29, 2020
• Last Updated: September 2, 2021

Record last verified: 2021-09

Locations

ES (1)