Educational Physiotherapy in Haemophilia

Haemophilia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825706
• Other study ID #: EducationalPhys
• Status: Completed
• Phase: N/A
• First received: June 30, 2016
• Last updated: July 6, 2016
• Start date: February 2012
• Est. completion date: April 2015

Study information

• Verified date: July 2016
• Source: Real Fundación Victoria Eugenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2015
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Haemophilia
• Hemophilia A

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Real Fundación Victoria Eugenia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline physical condition of joints after treatment and at 6 months	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).	Screening visit, within the first seven days after treatment and after six months follow-up visit
Primary	Change from baseline joint pain after treatment and at 6 months	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).	Screening visit, within the first seven days after treatment and after six months follow-up visit
Primary	Change from baseline perception of the quality of life after treatment and at 6 months	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).	Screening visit, within the first seven days after treatment and after six months follow-up visit
Primary	Change from baseline illness behavior after treatment and at 6 months	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).	Screening visit, within the first seven days after treatment and after six months follow-up visit
Primary	Change from baseline frequency of bleedings after treatment and at 6 months	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.	Screening visit, within the first seven days after treatment and after six months follow-up visit
Secondary	Radiological joint deterioration	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.	Screening visit
Secondary	Age	Age of patients included in the study	Screening visit
Secondary	Weight	Weight of the patients	Screening visit
Secondary	Height	Height of patients	Screening visit