Educational Physiotherapy in Haemophilia

NCT02825706 | Completed

• 1 other identifier: EducationalPhys
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Radiological joint deterioration

  Screening visit

• Age

  Screening visit

• Weight

  Screening visit

• Height

  Screening visit

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Educational physiotherapy group 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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Real Fundación Victoria Eugenia: lead

MeSH Terms

Conditions

Hemophilia A; Pain; Illness Behavior

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Rubén Cuesta-Barriuso, PhD

  Real Fundación Victoria Eugenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 7, 2016
• Study Start: February 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: April 1, 2015
• Last Updated: July 7, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share