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

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ClinicalTrials.gov Identifier: NCT04491318
Recruitment Status : Recruiting
First Posted : July 29, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Investigación en Hemofilia y Fisioterapia

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.


Condition or disease Intervention/treatment
Hemophilia Arthropathy Other: Observational

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Study Type : Observational
Estimated Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of COVID-19 Quarantine on the Musculoskeletal Status of Adult Hemophilia Patients. An Observational Study
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 25, 2020
Estimated Study Completion Date : July 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders

Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Change from baseline frequency of hemarthrosis after confinement period [ Time Frame: Screening visit, within the first seven days after confinement ]
    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.


Secondary Outcome Measures :
  1. Change from baseline joint health after confinement period [ Time Frame: Screening visit, within the first seven days after confinement ]
    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.

  2. Change from baseline joint pain after confinement period [ Time Frame: Screening visit, within the first seven days after confinement ]
    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).

  3. Change from baseline range of motion after confinement period [ Time Frame: Screening visit, within the first seven days after confinement ]
    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.

  4. Change from baseline joint pain after confinement period [ Time Frame: Screening visit, within the first seven days after confinement ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04491318


Contacts
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Contact: Rubén Cuesta-Barriuso, PhD +34 913146508 ruben.cuestab@gmail.com

Locations
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Spain
European University of Madrid Recruiting
Madrid, Spain, 28670
Contact: Rubén Cuesta-Barriuso, PhD       ruben.cuestab@gmail.com   
Sponsors and Collaborators
Investigación en Hemofilia y Fisioterapia
Investigators
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Principal Investigator: Rubén Cuesta-Barriuso, PhD Universidad Europea de Madrid
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Responsible Party: Investigación en Hemofilia y Fisioterapia
ClinicalTrials.gov Identifier: NCT04491318    
Other Study ID Numbers: HemoCov
First Posted: July 29, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Investigación en Hemofilia y Fisioterapia:
Hemophilic arthropathy
Joint pain
Joint health
Range of motion
Hemarthrosis
COVID-19
Additional relevant MeSH terms:
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Joint Diseases
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Musculoskeletal Diseases