HemophiliaNCT06960499
Predictors of Physical Activity in Adult Patients With Hemophilic Arthropathy
An observational study of Hemophilia, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hemophilia
- What is being tested?
- Surveys
- How many people
- 88 participants
- Where
- 1 siteSpain
- Study dates
- 4 May 2025to 20 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Predictors of Physical Activity in Adult Patients With Hemophilic Arthropathy. A Multicenter Cross-sectional Cohort Study
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.
- Conditions
- Hemophilia
- Being tested
- Surveys
- Keywords
- Hemophilia, Physical activity, Kinesiophobia, Functionality, Joint pain
- Medical subject headings
- Hemophilia A, Motor Activity, Kinesiophobia, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysOther
No intervention will be carried out in this study; the recruited patients will only complete the questionnaires provided below
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening visit
Secondary outcomes (12)
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
Measured: Screening visit
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.
Measured: Screening visit
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."
Measured: Screening visit
Measurement of age
The sociodemographic variable age will be measured in months completed from the date of birth
Measured: Screening visit
Measurement of marital status
The sociodemographic variable marital status will be measured as a qualitative variable (single/married/divorced/widowed).
Measured: Screening visit
Measurement of educational level
The sociodemographic variable educational level will be measured as a qualitative variable (primary education/secondary education/university education/vocational training).
Measured: Screening visit
Measurement of employment status
The sociodemographic variable employment status will be measured as a qualitative variable (self-employed/employed by others/civil servant/unemployed/unable to work/retired).
Measured: Screening visit
Measurement of hemophilia type
The clinical variable hemophilia type will be measured as a dichotomous variable (hemophilia A/hemophilia B).
Measured: Screening visit
Measurement of type of drug treatment
The clinical variable drug treatment will be measured as a dichotomous variable (on-demand treatment/prophylactic treatment).
Measured: Screening visit
Measurement of inhibitor development
The clinical variable development of antibodies prior to FVIII/FIX concentrates (inhibitors) will be measured as a dichotomous variable (yes/no).
Measured: Screening visit
Measurement of weight
The anthropometric variable weight will be measured as a quantitative variable (measured in kg).
Measured: Screening visit
Measurement of height
The anthropometric variable height will be measured as a quantitative variable (measured in cm).
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start4 May 2025 (estimated)
- Primary completion28 May 2025 (estimated)
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubén Cuesta-Barriuso, PhD, Universidad Católica San Antonio de Murcia
- Investigators
- Rubén Cuesta-Barriuso, Principal investigator, Universidad de Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960499
- Sponsor's protocol ID
- HeActivity
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Physical Activity in Adult Patients With Hemophilic Arthropathy. A Multicenter Cross-sectional Cohort Study
- ClinicalTrials.gov ID
- NCT06960499
- Acronym / sponsor ID
- HeActivity
- Conditions
- Hemophilia
- Keywords
- Hemophilia, Physical activity, Kinesiophobia, Functionality, Joint pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 4 May 2025 (estimated)
- Primary completion
- 28 May 2025 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observacional group | – | Other: SurveysPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveysNo intervention will be carried out in this study; the recruited patients will only complete the questionnaires provided below | Other | Observacional group |
Primary outcome
Measurement of physical activity level
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.
12 secondary outcomes
Measurement of fear of movement
Time frame: Screening visit
Measurement of degree of functional independence
Time frame: Screening visit
Measurement of the joint pain
Time frame: Screening visit
Measurement of age
Time frame: Screening visit
Measurement of marital status
Time frame: Screening visit
Measurement of educational level
Time frame: Screening visit
Measurement of employment status
Time frame: Screening visit
Measurement of hemophilia type
Time frame: Screening visit
Measurement of type of drug treatment
Time frame: Screening visit
Measurement of inhibitor development
Time frame: Screening visit
Measurement of weight
Time frame: Screening visit
Measurement of height
Time frame: Screening visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rubén Cuesta-Barriuso principal investigator
Universidad de Oviedo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rubén Cuesta-Barriuso, PhD (607547274, cuestaruben@uniovi.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of physical activity level (time frame: Screening visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.