Clinical trial NCT02825706: 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
Overall status: COMPLETED
Phase: NA
Conditions: Haemophilia
Keywords: Hemophilia
Educational Physiotherapy
Pain
Quality of life
Illness Behaviour
Elbow
Lead sponsor: Real Fundación Victoria Eugenia
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline physical condition of joints after treatment and at 6 months
timeFrame: Screening visit, within the first seven days after treatment and after six months follow-up visit
measure: Change from baseline joint pain after treatment and at 6 months
timeFrame: Screening visit, within the first seven days after treatment and after six months follow-up visit
measure: Change from baseline perception of the quality of life after treatment and at 6 months
timeFrame: Screening visit, within the first seven days after treatment and after six months follow-up visit
measure: Change from baseline illness behavior after treatment and at 6 months
timeFrame: Screening visit, within the first seven days after treatment and after six months follow-up visit
measure: Change from baseline frequency of bleedings after treatment and at 6 months
timeFrame: Screening visit, within the first seven days after treatment and after six months follow-up visit
Secondary outcomes:
measure: Radiological joint deterioration
timeFrame: Screening visit
measure: Age
timeFrame: Screening visit
measure: Weight
timeFrame: Screening visit
measure: Height
timeFrame: Screening visit
Other outcomes:
Locations:
Study officials:
affiliation: Real Fundación Victoria Eugenia
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References: