Educational Physiotherapy in Haemophilia

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Educational physiotherapy group

About this trial

This is an interventional treatment trial for Haemophilia focused on measuring Hemophilia, Educational Physiotherapy, Pain, Quality of life, Illness Behaviour, Elbow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).

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).

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).

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).

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.

Secondary Outcome Measures

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.

Age

Age of patients included in the study

Weight

Weight of the patients

Height

Height of patients

Full Information

NCT ID

NCT02825706

First Posted

June 30, 2016

Last Updated

July 6, 2016

Sponsor

Real Fundación Victoria Eugenia

1. Study Identification

Unique Protocol Identification Number

NCT02825706

Brief Title

Educational Physiotherapy in Haemophilia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Real Fundación Victoria Eugenia

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Haemophilia

Keywords

Hemophilia, Educational Physiotherapy, Pain, Quality of life, Illness Behaviour, Elbow

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

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.

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Educational physiotherapy group

Intervention Description

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 Outcome Measure Information:

Title

Change from baseline physical condition of joints after treatment and at 6 months

Description

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).

Time Frame