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Educational Physiotherapy in Haemophilia

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ClinicalTrials.gov Identifier: NCT02825706
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
Real Fundación Victoria Eugenia

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.


Condition or disease Intervention/treatment Phase
Haemophilia Other: Educational physiotherapy group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of an Educational Physiotherapy and Home Exercises Program in Adult Patients With Hemophilia: A Randomized Clinical Trial
Study Start Date : February 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group
The patients in experimental group received 60-minute educational sessions every two weeks about the pathophysiology of hemophilia, clinical manifestations, postural advice and prevention advice to avoid recurrent bleeding. Likewise, doubts on the clinical progress of hemophilic arthropathy, functional limitations and management of joint pain were resolved. In parallel with the educational sessions, patients followed a 15-week home exercise program performed once a day, 6 days a week. The program included muscle stretching exercises; isometric exercises; proprioceptive exercises on one leg with visual support; and a 20-minute walk. Low-intensity exercises with 20-25 repetitions were included.
Other: Educational physiotherapy group
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

No Intervention: Control group
The patients in the control group did not receive any educational sessions and did no exercise at all at home.



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825706


Sponsors and Collaborators
Real Fundación Victoria Eugenia
Investigators
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Principal Investigator: Rubén Cuesta-Barriuso, PhD Real Fundación Victoria Eugenia
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Responsible Party: Real Fundación Victoria Eugenia
ClinicalTrials.gov Identifier: NCT02825706    
Other Study ID Numbers: EducationalPhys
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Real Fundación Victoria Eugenia:
Hemophilia
Educational Physiotherapy
Pain
Quality of life
Illness Behaviour
Elbow
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn