About this trial
Introduction. The development of hemophilic arthropathy causes degenerative joint damage that leads to functional impairment, limiting physical activity and causing disability in patients with hemophilia.
Objectives. i) To assess the level of physical activity in patients with hemophilia; ii) To identify the best predictive model for physical activity in adult patients with hemophilic arthropathy.
Material and method. Multicenter cross-sectional cohort study. Eighty-eight patients will be recruited. The dependent variable will be physical activity (International Physical Activity Questionnaire). Secondary variables will be kinesiophobia (Tampa Kinesiophobia Scale), functionality (Functional Independence Scale in Hemophilia), pain intensity, and clinical, anthropometric, and sociodemographic variables.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients with hemophilia A or B
Over the age of majority
With a medical diagnosis of severe phenotype of the disease
With a medical diagnosis of hemophilic arthropathy in the lower limbs
Disqualifiers
Patients who require technical aids for walking
Patients who are dependent for activities of daily living
Patients over the age of 60
Patients with cognitive impairments that prevent them from understanding the questionnaires
Trial population
Patients with hemophilia A or B and hemophilic arthropathy where it is desired to assess the degree of physical activity and the main predictive factors for this.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Surveys
Other interventionNo intervention will be carried out in this study; the recruited patients will only complete the questionnaires provided below
Treatment groups
Trial outcomes
Primary outcomes
Measurement of physical activity level
Physical activity levels will be assessed using the International Physical Activity Questionnaire (IPAQ). This tool assesses physical activity levels in adults aged 18 to 65. It consists of seven questions that ask about the frequency, duration, and intensity of physical activity performed in the last week. It also assesses the time spent walking and sitting. The results are classified into three categories: low, moderate, and high activity. The unit of measurement is metabolic equivalent task (METS), where a higher number of METS indicates greater physical activity.
Secondary outcomes
Measurement of fear of movement
Fear of movement will be measured using the Tampa Kinesiophobia Scale (TSK). This self-reported questionnaire consists of 17 items, using a 4-point Likert scale. It comprises two subscales: avoidance of physical exertion due to fear of injury or pain, and belief that significant underlying medical problems exist. The total score ranges from 17 to 68 points, with a score of 37 or more indicating a high level of kinesiophobia
Measurement of degree of functional independence
The degree of functional independence of patients will be measured using the Functional Independence Scale for Hemophilia (FISH). This tool measures eight activities of daily living: eating, personal hygiene, dressing, transferring from a chair, squatting, walking, climbing stairs, and running. Each activity is rated according to the level of assistance required, using a scale from 1 to 4. The total score can reach a maximum of 32 points, with a higher score indicating greater functional independence.
Measurement of the joint pain
Pain intensity will be measured using the Visual Analog Scale (VAS). This is a simple and effective tool for measuring pain intensity. It consists of a horizontal line, usually 10 cm long, with one end representing "no pain" and the other "maximum pain imaginable."
Measurement of age
The sociodemographic variable age will be measured in months completed from the date of birth
Sponsors and contacts
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