NCT06960499

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

May 4, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2025

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2025

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

May 7, 2025

Status Verified

April 1, 2025

Enrollment Period

24 days

First QC Date

April 28, 2025

Last Update Submit

April 28, 2025

Conditions

Keywords

HemophiliaPhysical activityKinesiophobiaFunctionalityJoint pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    Screening visit

Secondary Outcomes (12)

  • Measurement of fear of movement

    Screening visit

  • Measurement of degree of functional independence

    Screening visit

  • Measurement of the joint pain

    Screening visit

  • Measurement of age

    Screening visit

  • Measurement of marital status

    Screening visit

  • +7 more secondary outcomes

Study Arms (1)

Observacional group

Patients with hemophilia A or B, of legal age, with a medical diagnosis of severe phenotype of the disease and hemophilic arthropathy in the lower limbs.

Other: Surveys

Interventions

SurveysOTHER

No intervention will be carried out in this study; the recruited patients will only complete the questionnaires provided below

Observacional group

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica San Antonio de Murcia

Murcia, 33006, Spain

Location

MeSH Terms

Conditions

Hemophilia AMotor ActivityKinesiophobiaArthralgia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehaviorPhobic DisordersAnxiety DisordersMental DisordersJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Rubén Cuesta-Barriuso

    Universidad de Oviedo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rubén Cuesta-Barriuso, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 28, 2025

First Posted

May 7, 2025

Study Start

May 4, 2025

Primary Completion

May 28, 2025

Study Completion

June 20, 2025

Last Updated

May 7, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations