COVID-19 Quarantine on Musculoskeletal Status in Hemophilia

Hemophilia Arthropathy Clinical Trial

— HemoCov  

Official title:

Effects of COVID-19 Quarantine on the Musculoskeletal Status of Adult Hemophilia Patients. An Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04491318
• Other study ID #: HemoCov
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: July 29, 2020

Study information

• Verified date: September 2021
• Source: Investigación en Hemofilia y Fisioterapia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 29, 2020
• Est. primary completion date: July 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia Arthropathy
• Joint Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	European University of Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Investigación en Hemofilia y Fisioterapia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline joint health after confinement period	Joint status was assessed with the Hemophilia Joint Health Score (HJHS) version 2.1. This tool, specific for hemophilia patients, evaluates joint deterioration in the ankle, knee and elbow joints. This scale measures 8 items: swelling, duration of swelling, atrophy and muscle strength, crepitus, mobility and joint pain. The scoring range for this additive scale is 0-20 points at each joint.	Screening visit, within the first seven days after confinement
Secondary	Change from baseline joint pain after confinement period	Joint pain perception was measured with the visual analog scale. This scale has shown moderate reliability. The scoring range is from 0 to 10 points (from no pain to maximum perceived pain).	Screening visit, within the first seven days after confinement
Secondary	Change from baseline range of motion after confinement period	Range of motion was measured with a goniometer to assess flexion and extension of the elbow, knee, and ankle joints. This measuring instrument has shown good intra and inter-observer reliability in the joints evaluated. The measurement protocols described by Cleffken, Green and Gerhardt were used to measure mobility in the elbow, knee and ankle joints, respectively.	Screening visit, within the first seven days after confinement
Secondary	Change from baseline joint pain after confinement period	The pressure algometer measures the pressure, bilaterally, at which the patient perceives pressure pain on the evaluation point, as the pressure increases at a speed of approximately 50kPa / s. The unit of measurement is in Newton / cm2. The perception of joint pain in the elbow was measured on the lateral epicondyle, in the knee at a distance of 3 cm from the midpoint of the internal edge of the patella, and in the ankle it was measured in the ventral region of the lateral malleolus.	Screening visit, within the first seven days after confinement