Universidad Católica San Antonio de Murcia
Murcia, 33006, Spain
NCT Number: NCT06960499
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.
Trial opening soon.
Get Notified18 year–65 year
Male
Observational
Murcia, 33006, Spain
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention will be carried out in this study; the recruited patients will only complete the questionnaires provided below
Time frame: Screening visit
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.
Time frame: Screening visit
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
Time frame: Screening visit
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.
Time frame: Screening visit
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."
Time frame: Screening visit
The sociodemographic variable age will be measured in months completed from the date of birth
Time frame: Screening visit
The sociodemographic variable marital status will be measured as a qualitative variable (single/married/divorced/widowed).
Time frame: Screening visit
The sociodemographic variable educational level will be measured as a qualitative variable (primary education/secondary education/university education/vocational training).
Time frame: Screening visit
The sociodemographic variable employment status will be measured as a qualitative variable (self-employed/employed by others/civil servant/unemployed/unable to work/retired).
Time frame: Screening visit
The clinical variable hemophilia type will be measured as a dichotomous variable (hemophilia A/hemophilia B).
Time frame: Screening visit
The clinical variable drug treatment will be measured as a dichotomous variable (on-demand treatment/prophylactic treatment).
Time frame: Screening visit
The clinical variable development of antibodies prior to FVIII/FIX concentrates (inhibitors) will be measured as a dichotomous variable (yes/no).
Time frame: Screening visit
The anthropometric variable weight will be measured as a quantitative variable (measured in kg).
Time frame: Screening visit
The anthropometric variable height will be measured as a quantitative variable (measured in cm).
Contact information is provided by the study sponsor or research team.
Universidad Católica San Antonio de Murcia
Other
Predictors of Physical Activity in Adult Patients With Hemophilic Arthropathy. A Multicenter Cross-sectional Cohort Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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