Multidisciplinary Evaluation of Patients With Hemophilia

Haemophilia Clinical Trial

— HOLISTIC  

Official title:

Multidisciplinary Assessment of the Physical, Functional and Psychosocial Alterations in Patients With Hemophilia. An Observational Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02198430
• Other study ID #: Hemo-HOLISTIC
• Secondary ID: HOLISTIC
• Status: Recruiting
• Phase: N/A
• First received: July 22, 2014
• Last updated: October 19, 2015
• Start date: May 2014
• Est. completion date: February 2016

Study information

• Verified date: September 2015
• Source: Universidad de Murcia
• Contact: Ana Torres-Ortuño, PhD
• Phone: 868887170
• Email: atorres.ortuno[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial Summary

Multidisciplinary assessment of the physical, functional and psychosocial alterations in patients with hemophilia around the country. The aims of this study are:

• Descriptive study of joint involvement in hemophilia patients with and without a history of hemarthrosis.

• Descriptive study of the alterations of periarticular muscle strength as a result of acute processes or the development of chronic articular sequelae.

• Descriptive study of biomechanical changes in lower limb joints and their impact on gait in patients with hemophilia.

• Descriptive study of the joint space, regarding hemarthrosis and synovitis, intraarticular by ultrasonography.

• Descriptive study of the relationship between skeletal muscle pathology in patients with hemophilia and their perceptions of it and their quality of life.

Description:

Observational study that will allow us:

Analyze and evaluate the skeletal muscle of patients with hemophilia involvement.

Describe the periarticular muscular deficit, depending on the degree of injury, age, presence of inhibitors and the development of physical activity.

Identify the relationship between the functional deficit by clinical assessment performed with the use of validated scales measure force production with patients.

Observe the presence of joint bleeds in children with hemophilia and synovial hypertrophy developing therein.

Detect biomechanical abnormalities of the lower limbs and their impact on gait in patients with hemophilia.

Assess the factors that influence the perception of illness and quality of life of patients with hemophilia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 8 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with hemophilia A and B.

• Patients of all ages (pediatric, adolescents, youth and adults).

• With or without joint involvement clinically diagnosed, and with or without a previous history of hemarthrosis joint loading.

• Patients with or without inhibitors.

Exclusion Criteria:

• Patients without prior walking capacity.

• Patients diagnosed with other congenital coagulopathy (von Willebrand disease, etc..).

• Patients with neurological or cognitive impairments that prevent understanding the questionnaires and physical tests.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Haemophilia
• Hemophilia A

Locations

Country	Name	City	State
Spain	Universidad de Murcia	Murcia
Spain	Universidad de Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the range of motion of elbows, knees and ankles	Measurement with a goniometric evaluation, using a universal goniometer and by a pilotage intraobserver	Screening visit	No
Primary	Assess muscle strength arm, thigh and leg	Measurement by the measurement of muscular balance (scale Daniels). The strength of quadriceps, hamstrings, twins, tibialis anterior, biceps and triceps will be evaluated.	Screening visit	No
Primary	Assess the perception of joint pain	Measurement through the visual analogue scale (VAS), with a scale from 0 (no pain) to 10 (worst pain imaginable).	Screening visit	No
Primary	Assess the perception of quality of life	Measurement through the Haemophilia-QoL questionnaire	Screening visit	No
Primary	Assess the status intraarticular	Measurement through ultrasonography analysis of the knees, ankles and elbows	Screening visit	No
Primary	Assess the clinical joint status	Measurement through the Haemophilia Joint Health Score (HJHS)	Screening visit	No
Primary	Assessment of the sociodemographic variables of patients	Measure of age (years); weight (kg); height (cm); training (basic studies, University, vocational training); family history of hemophilia; distance to the hospital; and sports (days / week).	Screening visit	No
Secondary	Assessment of clinical patient variables	Hemophilia type measuring (A or B); severity of hemophilia (severe, moderate, mild); type of treatment (prophylactic / request); presence of inhibitors; and hemarthrosis in the previous month	Screening visit	No