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

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ClinicalTrials.gov Identifier: NCT04491318
Recruitment Status : Completed
First Posted : July 29, 2020
Last Update Posted : September 2, 2021
Sponsor:
Information provided by (Responsible Party):
Investigación en Hemofilia y Fisioterapia

Tracking Information
First Submitted Date July 27, 2020
First Posted Date July 29, 2020
Last Update Posted Date September 2, 2021
Actual Study Start Date July 1, 2020
Actual Primary Completion Date July 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 27, 2020)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 27, 2020)
  • 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.
  • 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).
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Hemophilia Arthropathy
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.
Study Groups/Cohorts 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.
Intervention: Other: Observational
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 27, 2020)
27
Original Estimated Enrollment Same as current
Actual Study Completion Date July 29, 2020
Actual Primary Completion Date July 25, 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04491318
Other Study ID Numbers HemoCov
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Investigación en Hemofilia y Fisioterapia
Study Sponsor Investigación en Hemofilia y Fisioterapia
Collaborators Not Provided
Investigators
Principal Investigator: Rubén Cuesta-Barriuso, PhD Universidad Europea de Madrid
PRS Account Investigación en Hemofilia y Fisioterapia
Verification Date September 2021