Clinical trial NCT06960499: Predictors of Physical Activity in Adult Patients With Hemophilic Arthropathy
Official title: Predictors of Physical Activity in Adult Patients With Hemophilic Arthropathy. A Multicenter Cross-sectional Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hemophilia
Keywords: Hemophilia
Physical activity
Kinesiophobia
Functionality
Joint pain
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 88
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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: Inclusion Criteria:

* 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
* Under on-demand or prophylactic drug treatment.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Measurement of physical activity level
timeFrame: Screening visit
Secondary outcomes:
measure: Measurement of fear of movement
timeFrame: Screening visit
measure: Measurement of degree of functional independence
timeFrame: Screening visit
measure: Measurement of the joint pain
timeFrame: Screening visit
measure: Measurement of age
timeFrame: Screening visit
measure: Measurement of marital status
timeFrame: Screening visit
measure: Measurement of educational level
timeFrame: Screening visit
measure: Measurement of employment status
timeFrame: Screening visit
measure: Measurement of hemophilia type
timeFrame: Screening visit
measure: Measurement of type of drug treatment
timeFrame: Screening visit
measure: Measurement of inhibitor development
timeFrame: Screening visit
measure: Measurement of weight
timeFrame: Screening visit
measure: Measurement of height
timeFrame: Screening visit
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad Católica San Antonio de Murcia
Study officials:
affiliation: Universidad de Oviedo
name: Rubén Cuesta-Barriuso
role: PRINCIPAL_INVESTIGATOR
References: