Clinical Trial: Educational Physiotherapy in Haemophilia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effectiveness of an Educational Physiotherapy and Home Exercises Program in Adult Patients With Hemophilia: A Randomized Clinical Trial

Brief Summary:

Although arthropathy is a serious problem in patients with hemophilia due to the associated morbidity and incapacity, to the best of the investigators knowledge, no studies have looked at the effect of educational physiotherapy for its clinical improvement.

This contribution presents the results of educational physiotherapy program applied for 15 weeks with home exercises - in patients with hemophilic arthropathy. After treatment, experimental group showed improved a significant reduction of pain, and best quality of life al illness behaviour. During treatment no patient showed elbow haemarthrosis, which underlines the safety of this physiotherapy program.


Detailed Summary:
Sponsor: Real Fundación Victoria Eugenia

Current Primary Outcome:

  • Change from baseline physical condition of joints after treatment and at 6 months [ Time Frame: Screening visit, within the first seven days after treatment and after six months follow-up visit ]
    The physical condition of joints was assessed using the Gilbert scale that measures swelling, muscle atrophy, joint crepitus, range of motion, axial deformity and instability. Scores range from 0 to 12 (0 represents no joint injury and 12 represents maximum joint deterioration).
  • Change from baseline joint pain after treatment and at 6 months [ Time Frame: Screening visit, within the first seven days after treatment and after six months follow-up visit ]
    Joint pain was assessed using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain at all) to 10 (the worst pain imaginable by the patient).
  • Change from baseline perception of the quality of life after treatment and at 6 months [ Time Frame: Screening visit, within the first seven days after treatment and after six months follow-up visit ]
    The Haemophilia A-36 questionnaire was used to assess the perception of the quality of life. This questionnaire consists of 36 items that assess 9 domains (physical health, daily activities, joint damage and pain, treatment satisfaction, treatment difficulties, emotional functioning, mental health and social relationships).
  • Change from baseline illness behavior after treatment and at 6 months [ Time Frame: Screening visit, within the first seven days after treatment and after six months follow-up visit ]
    To assess illness behavior, pa

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Radiological joint deterioration [ Time Frame: Screening visit ]
      All patients had an assessment of radiological joint deterioration using the Pettersson scale. This scale, with scores ranging from 0 (a normal joint) to 13 (maximum joint deterioration), is the most widely used to assess joint degeneration produced by hemophilic arthropathy. The evaluation of radiological joint damage was done at the beginning of the study.
    • Age [ Time Frame: Screening visit ]
      Age of patients included in the study
    • Weight [ Time Frame: Screening visit ]
      Weight of the patients
    • Height [ Time Frame: Screening visit ]
      Height of patients


    Original Secondary Outcome: Same as current

    Information By: Real Fundación Victoria Eugenia

    Dates:
    Date Received: June 30, 2016
    Date Started: February 2012
    Date Completion:
    Last Updated: July 6, 2016
    Last Verified: July 2016