The Effects of Exercises on Gait in Hemophilic Individuals

Not Applicable

Completed

• Conditions: Hemophilic Arthropathy

• Registration Number: NCT04297696
• Lead Sponsor: Cukurova University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-02-29
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-05
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-02
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Haemophilia Joint Health Score	Baseline, Change from baseline HJHS at 2 months, Change from baseline HJHS at 6 months	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.
Range of Motion Analysis with Kinovea Software	Baseline, Change from baseline range of motion during gait at 2 months, Change from baseline range of motion during gait at 6 months.	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.

Secondary Outcome Measures

Name	Time	Method
Haemophilia Quality of Life Questionnaire for Adults	Baseline, Change from baseline 6min-WT at 2 months, Change from baseline Quality of life at 6 months	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
Six Minutes Walking Test	Baseline, Change from baseline 6min-WT at 2 months, Change from baseline 6min-WT at 6 months	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.

Trial Locations

Locations (1)

Cukurova University Gym; 🇹🇷 Adana, Turkey