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Completed

NCT Number: NCT04297696

The Effects of Exercises on Gait in Hemophilic Individuals

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.

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Key information

Conditions

Hemophilic Arthropathy Behavior Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders Motor Activity

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University Gym

Adana, 01100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

therapeutic exercises

Other

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

Primary outcomes

  1. Haemophilia Joint Health Score

    Time frame: 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.

  2. Range of Motion Analysis with Kinovea Software

    Time frame: 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 outcomes

  1. Haemophilia Quality of Life Questionnaire for Adults

    Time frame: 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

  2. Six Minutes Walking Test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 5, 2020
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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