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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

Tracking Information
First Submitted Date  ICMJE June 30, 2016
First Posted Date  ICMJE July 7, 2016
Last Update Posted Date July 7, 2016
Study Start Date  ICMJE February 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2016)
  • 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, 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).
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2016)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Educational Physiotherapy in Haemophilia
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Haemophilia
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Educational physiotherapy group
  • No Intervention: Control group
    The patients in the control group did not receive any educational sessions and did no exercise at all at home.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2016)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02825706
Other Study ID Numbers  ICMJE EducationalPhys
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Real Fundación Victoria Eugenia
Study Sponsor  ICMJE Real Fundación Victoria Eugenia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rubén Cuesta-Barriuso, PhD Real Fundación Victoria Eugenia
PRS Account Real Fundación Victoria Eugenia
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP