Educational Physiotherapy in Haemophilia

NCT ID: NCT02825706

Last Updated: 2016-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-04-30

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.

Conditions

Haemophilia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Educational physiotherapy group

Intervention Type: OTHER

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

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Real Fundación Victoria Eugenia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rubén Cuesta-Barriuso, PhD

Role: PRINCIPAL_INVESTIGATOR

Real Fundación Victoria Eugenia

Other Identifiers

EducationalPhys

Identifier Type: -

Identifier Source: org_study_id