The Effects of Exercises on Gait in Hemophilic Individuals

Study Overview
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Brief Summary
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Arthropathy characterized by synovitis, cartilage degeneration, subchondral and interosseous cysts occur due to hemorrhage in hemophilia. This situation causes to chronic pain, decreasing in range of motion, muscle strength, proprioception. Disorders in these parameters are the main causes of gait dysfunction. The aim of this study is to investigate the effects of therapeutic exercises on target joint functions and gait kinematics, and to determine possible complications related to exercise in hemophilic patients.

Official Title
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Investigation of Effectiveness of Therapeutic Exercises on Target Joint Functions and Gait in Hemophilic Arthropathic Patients.

Conditions
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Hemophilic Arthropathy

Intervention / Treatment
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* Other: Therapeutic exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be diagnosed as Hemophilia A or Hemophilia B To be over 18 years old To have hemophilic arthropathy in at least one joint Undergoing prophylaxis or factor VIII-IX replacement therapy Exclusion Criteria: Having another congenital coagulopathy, such as Von Willebrand syndrome To be unable to walk due to hemophilic arthropathy Having another musculoskeletal problem Individuals with inhibitors against Factor VIII-IX

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise group<br>therapeutic exercises | Other: Therapeutic exercises<br>* A program including warm-up period and neuromuscular exercises is applied progressively in two phases.<br>|
| No Intervention: control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemophilia Joint Health Score | Haemophilia Joint Health Score (HJHS) will be applied to evaluate the joint functions of hemophilic individuals. HJHS is a sensitive and valid test used to determine the severity of clinical symptoms that result from hemarthrosis. This comprises an assessment of joints with regards to swelling, muscle atrophy, crepitus, range of motion, joint pain, strength, and global gait. The score for each joint is summed to obtain a total score ranging from 0 to 124, where no joint damage is indicated by a score of 0. | Baseline, Change from baseline HJHS at 2 months, Change from baseline HJHS at 6 months | 
| Range of Motion Analysis with Kinovea Software | Range of motion (ROM) analysis during gait will be done by analyzing video images with computer software Kinovea. Kinovea is a free software used by sports and healthcare professionals to analyze video images during physical activity. Furthermore, it is a sensitive method that can be used to evaluate the range of motion of the lower limb joints during gait. ROM analysis of the ankle and knee joints will be done with Kinovea in the heel strike-midstance-toe off and mid-swing phases. | Baseline, Change from baseline range of motion during gait at 2 months, Change from baseline range of motion during gait at 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemophilia Quality of Life Questionnaire for Adults | The Haem-A-QoL questionnaire including 10 sections and 46 questions was used to evaluate the changes in the Quality of life of PwH; low scores indicate high QoL | Baseline, Change from baseline 6min-WT at 2 months, Change from baseline Quality of life at 6 months | 
| Six Minutes Walking Test | Six-Minutes Walking Test (6min-WT) will be applied to determine the effects of therapeutic exercises on the aerobic capacity of hemophilic individuals. This test is a valid and reliable method for determining aerobic capacity in patients with neuromuscular problems. High walking distance indicates high aerobic capacity. | Baseline, Change from baseline 6min-WT at 2 months, Change from baseline 6min-WT at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemophilia, exercise, gait kinematic