Educational Physiotherapy in Haemophilia

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

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.

Study Overview

• Status: Completed
• Conditions: Haemophilia
• Intervention / Treatment: Other: Educational physiotherapy group

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Age	Age of patients included in the study	Screening visit
Weight	Weight of the patients	Screening visit
Height	Height of patients	Screening visit

Collaborators and Investigators

• Sponsor: Real Fundación Victoria Eugenia

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Estimate): July 7, 2016
• Last Update Submitted That Met QC Criteria: July 6, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Pain; Quality of life; Hemophilia; Elbow; Educational Physiotherapy; Illness Behaviour
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A
• Other Study ID Numbers: EducationalPhys

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No