Comparison of Pulmonary Function, Exercise Capacity, and Physical Activity Level Between Children With Hemophilia and Healthy Controls

NCT ID: NCT06636565

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-25

Study Completion Date

2025-07-25

Brief Summary

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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.

Detailed Description

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Conditions

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Hemophilia Healthy Children

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Hemophilia

Children with hemophilia

No intervention

Intervention Type OTHER

No intervention

Healthy children

Healthy children

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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,
* 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

Exclusion Criteria

* 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,
* 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
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Aslihan Cakmak-Onal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aslihan Cakmak-Onal, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Ebru Calik-Kutukcu, PhD, PT

Role: STUDY_DIRECTOR

Hacettepe University

Hande Guney-Deniz, PhD, PT

Role: STUDY_CHAIR

Hacettepe University

Ş. Selin Aytac-Eyupoglu, MD

Role: STUDY_CHAIR

Hacettepe University

Firat Tan, MSc, PT

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Locations

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Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Ankara, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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FTREK24/65

Identifier Type: -

Identifier Source: org_study_id

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