The Effects of Exercises on Gait in Hemophilic Individuals

Hemophilic Arthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04297696
• Other study ID #: 89/55
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 2, 2020

Study information

• Verified date: November 2020
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemophilic Arthropathy
• Joint Diseases

Intervention

Other:
• Therapeutic exercises
A program including warm-up period and neuromuscular exercises is applied progressively in two phases.

Locations

Country	Name	City	State
Turkey	Cukurova University Gym	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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