The Effects of Exercises on Gait in Hemophilic Individuals

NCT04297696 | Completed

• 1 other identifier: 89/55
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilic Arthropathy

Keywords

hemophilia; exercise; gait kinematic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

• Six Minutes Walking Test

  Baseline, Change from baseline 6min-WT at 2 months, Change from baseline 6min-WT at 6 months

Study Arms (2)

exercise group

EXPERIMENTAL

therapeutic exercises

Other: Therapeutic exercises

control group

NO INTERVENTION

Interventions

Therapeutic exercises OTHER

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

exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University Gym

Adana, 01100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemophilia A; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Nevin Atalay Güzel, Prof Dr

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 29, 2020
• First Posted: March 5, 2020
• Study Start: January 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: June 2, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

TU (1)