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NCT Number: NCT02825706

Educational Physiotherapy in Haemophilia

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.

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Key information

Conditions

Haemophilia 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 Illness Behavior Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients diagnosed with hemophilia A or B
  • Patients over 18 years
  • Patients with hemophilic arthropathy with at least 1 involved joint (elbow, knee or ankle)
  • having signed the informed consent document.

Exclusion criteria

  • Patients diagnosed with other congenital bleeding disorders (i.e. von Willebrand disease)
  • Patients who developed antibodies to FVIII or FIX (inhibitors)
  • Those not able to ambulate as a result of hemophilic arthropathy or any other disability

Treatment and study plan

Educational physiotherapy group

Other

20 patients with hemophilia were randomly allocated to an educational intervention or to a control group. The educational intervention was performed every two weeks during 15-week and home exercises were performed once a day, 6 days a week, in the same time

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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, patients completed the Illness Behavior Questionnaire (IBQ). This scale consists of 62 items and 8 domains (hypochondriasis, disease conviction, psychological vs. somatic perception of illness, affective inhibition, affective disturbance, denial and irritability).

  5. Change from baseline frequency of bleedings 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 frequency of bleeding is measured with a record which complete the patients, where they indicate the incidence of hematomas and hemarthrosis during the treatment and follow-up.

Secondary outcomes

  1. 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.

  2. Age

    Time frame: Screening visit

    Age of patients included in the study

  3. Weight

    Time frame: Screening visit

    Weight of the patients

  4. Height

    Time frame: Screening visit

    Height of patients

Sponsors and collaborators

Lead sponsor

Real Fundación Victoria Eugenia

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2015
First posted
Jul 7, 2016
Registry last updated
Jul 7, 2016

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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