HemophiliaNCT06636565
Comparison of Pulmonary Function, Exercise Capacity, and Physical Activity Level Between Children With Hemophilia and Healthy Controls
An observational study of Hemophilia and Healthy Children, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Hemophilia is a rare X-linked congenital bleeding disorder characterized by deficiency of clotting factor VIII (hemophilia A) or deficiency of factor IX (hemophilia B) with complex diagnosis and management. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemophilia, Healthy Children
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jul 2024to 25 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children with hemophilia and their healthy peers
Who may be able to join
- Having been diagnosed with hemophilia and being clinically stable,
- Being between the ages of 8-18,
- Being on prophylaxis treatment (a routine treatment),
- Being 125 cm or taller,
- Being inhibitor negative at the time of enrollment,
- To be able to cooperate with the tests to be performed,
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- Being willing to participate in the study.
- Not having any known internal or chronic disease
- Being male between the ages of 8-18
- Having full range of motion in the upper extremity
- Having full range of motion in the lower extremity
- Not having any history of injury or surgery in the lower extremity
- Being 125 cm or taller
- Being willing to participate in the study
Who cannot join
- Being inhibitor positive at the time of enrollment,
- Having a history of acute joint bleeding,
- Being unable to bear weight on the extremities,
- Having a history of acute intramuscular bleeding,
- Having undergone radionuclide synovectomy,
- Having a history of surgery on any of the lower extremity joints,
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- Having a severe cardiovascular, orthopedic or neurological problem that may affect the assessments.
- Control group
- Having any problem that may affect the tests
- Not having full range of motion in the upper extremity
- Having a history of injury or surgery in any of the lower extremity joints
- Having a neurological deficit
- Having pain or movement limitation in the lower extremity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, Ankara, 06100
About this study
Hemophilia is a rare X-linked congenital bleeding disorder characterized by deficiency of clotting factor VIII (hemophilia A) or deficiency of factor IX (hemophilia B) with complex diagnosis and management. Participation in physical activity is still limited in children with hemophilia, probably due to protective attitudes of families/patients and avoidance of activity, and possibly also as a result of chronic pain. Exercise capacity has been identified as a protective factor against joint problems in hemophilia. Aerobic fitness is associated with better pulmonary function in children. Chronic pain and decreased range of motion due to recurrent bleeding in joints and muscles in hemophilia may indirectly affect posture and respiratory mechanics, leading to impaired pulmonary function. This study aims to compare pulmonary function, exercise capacity, posture, and physical activity level between children with hemophilia and healthy controls and to investigate the relationship between these parameters.
- Conditions
- Hemophilia, Healthy Children
- Being tested
- No intervention
- Keywords
- Hemophilia, Exercise capacity, Pulmonary function
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Hemophilia | Children with hemophilia Receives: Other: No intervention | |
| Healthy children | Healthy children Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced vital capacity
Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.
Measured: 1st day
Forced expiratory volume in one second
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded.
Measured: 1st day
Forced expiratory volume in one second/forced vital capacity ratio
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second/forced vital capacity ratio will be recorded.
Measured: 1st day
Peak expiratory flow
Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded. will be recorded.
Measured: 1st day
Forced mid-expiratory flow (FEF25-75)
Pulmonary function test using a spirometer will be performed. Forced mid-expiratory flow (FEF25-75) will be recorded. will be recorded.
Measured: 1st day
Hemophilia Joint Health Score
Hemophilia Joint Health Score is a scoring used by physiotherapists in hemophilia treatment centers to detect early hemophilic arthropathy symptoms and to monitor joint health. HJHS consists of edema (0-3), duration of edema (0-1), muscle atrophy (0-2), crepitus during movement (0-2), loss of flexion (0-3), loss of extension (0-3), joint pain (0-2) and evaluation of muscle strength of knees, ankles and elbows (0-4) and global gait score (0-4). The maximum score is 124, with higher scores indicating worse joint health.
Measured: 1st day
Corbin Posture Rating Scale
Corbin Posture Rating Scale and observational posture analysis. It is an assessment consisting of lateral and posterior posture analysis. '0' is excellent, 12 and above indicates poor posture.
Measured: 1st day
Exercise capacity
To assess exercise capacity, a symptom-limited cardiopulmonary exercise test will be performed on a bicycle ergometer using Godfrey protocol. Cardiopulmonary responses and effort perceptions will be recorded. In Godfrey protocol, workload increases are adjusted according to height: workload is increased by 10 W/min for < 125 cm, by 15 W/min for 125-150 cm and by 20 W/min for >150 cm.
Measured: 1st day
Physical activity level
The Physical Activity Questionnaire for Children (PAQ-C) and the Physical Activity Questionnaire for Adolescents (PAQ-A) will be used to assess physical activity levels. The Turkish versions of these assessment tools have been shown to be valid and reliable.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start25 Jul 2024
- Primary completion25 Jul 2025
- Study completion25 Jul 2025
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslihan Cakmak-Onal, Hacettepe University
- Investigators
- Aslihan Cakmak-Onal, PhD, PT, Principal investigator, Hacettepe UniversityEbru Calik-Kutukcu, PhD, PT, Study director, Hacettepe UniversityHande Guney-Deniz, PhD, PT, Study chair, Hacettepe UniversityŞ. Selin Aytac-Eyupoglu, MD, Study chair, Hacettepe UniversityFirat Tan, MSc, PT, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636565
- Sponsor's protocol ID
- FTREK24/65
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 10 Sep 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 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pulmonary Function, Exercise Capacity, and Physical Activity Level Between Children With Hemophilia and Healthy Controls
- ClinicalTrials.gov ID
- NCT06636565
- Acronym / sponsor ID
- FTREK24/65
- Conditions
- Hemophilia, Healthy Children
- Keywords
- Hemophilia, Exercise capacity, Pulmonary function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 10 Oct 2024 (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.
Hemophilia is a rare X-linked congenital bleeding disorder characterized by deficiency of clotting factor VIII (hemophilia A) or deficiency of factor IX (hemophilia B) with complex diagnosis and management. Participation in physical activity is still limited in children with hemophilia, probably due to protective attitudes of families/patients and avoidance of activity, and possibly also as a result of chronic pain. Exercise capacity has been identified as a protective factor against joint problems in hemophilia. Aerobic fitness is associated with better pulmonary function in children. Chronic pain and decreased range of motion due to recurrent bleeding in joints and muscles in hemophilia may indirectly affect posture and respiratory mechanics, leading to impaired pulmonary function. This study aims to compare pulmonary function, exercise capacity, posture, and physical activity level between children with hemophilia and healthy controls and to investigate the relationship between these parameters.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemophilia | – | Other: No interventionChildren with hemophilia |
| Healthy children | – | Other: No interventionHealthy children |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children with hemophilia and their healthy peers
Key inclusion criteria (14 listed)
- Having been diagnosed with hemophilia and being clinically stable,
- Being between the ages of 8-18,
- Being on prophylaxis treatment (a routine treatment),
- Being 125 cm or taller,
- Being inhibitor negative at the time of enrollment,
Key exclusion criteria (13 listed)
- Being inhibitor positive at the time of enrollment,
- Having a history of acute joint bleeding,
- Being unable to bear weight on the extremities,
- Having a history of acute intramuscular bleeding,
- Having undergone radionuclide synovectomy,
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 |
|---|---|---|
| No interventionNo intervention | Other | Healthy children, Hemophilia |
Primary outcome
Forced vital capacity
Time frame: 1st day
Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.
Forced expiratory volume in one second
Time frame: 1st day
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded.
Forced expiratory volume in one second/forced vital capacity ratio
Time frame: 1st day
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second/forced vital capacity ratio will be recorded.
Peak expiratory flow
Time frame: 1st day
Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded. will be recorded.
Forced mid-expiratory flow (FEF25-75)
Time frame: 1st day
Pulmonary function test using a spirometer will be performed. Forced mid-expiratory flow (FEF25-75) will be recorded. will be recorded.
Hemophilia Joint Health Score
Time frame: 1st day
Hemophilia Joint Health Score is a scoring used by physiotherapists in hemophilia treatment centers to detect early hemophilic arthropathy symptoms and to monitor joint health. HJHS consists of edema (0-3), duration of edema (0-1), muscle atrophy (0-2), crepitus during movement (0-2), loss of flexion (0-3), loss of extension (0-3), joint pain (0-2) and evaluation of muscle strength of knees, ankles and elbows (0-4) and global gait score (0-4). The maximum score is 124, with higher scores indicating worse joint health.
Corbin Posture Rating Scale
Time frame: 1st day
Corbin Posture Rating Scale and observational posture analysis. It is an assessment consisting of lateral and posterior posture analysis. '0' is excellent, 12 and above indicates poor posture.
Exercise capacity
Time frame: 1st day
To assess exercise capacity, a symptom-limited cardiopulmonary exercise test will be performed on a bicycle ergometer using Godfrey protocol. Cardiopulmonary responses and effort perceptions will be recorded. In Godfrey protocol, workload increases are adjusted according to height: workload is increased by 10 W/min for < 125 cm, by 15 W/min for 125-150 cm and by 20 W/min for >150 cm.
Physical activity level
Time frame: 1st day
The Physical Activity Questionnaire for Children (PAQ-C) and the Physical Activity Questionnaire for Adolescents (PAQ-A) will be used to assess physical activity levels. The Turkish versions of these assessment tools have been shown to be valid and reliable.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 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. This study is not recruiting at the moment.
Aslihan Cakmak-Onal, PhD, PT principal investigator
Hacettepe University
Ebru Calik-Kutukcu, PhD, PT study director
Hacettepe University
Hande Guney-Deniz, PhD, PT study chair
Hacettepe University
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 and Healthy Children, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 14 inclusion and 13 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: finished, as of the sponsor's last update on 10 Sep 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced vital capacity (time frame: 1st day). The study lists 9 primary outcomes in all. 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 10 Sep 2025.