NCT02165592

Brief Summary

Analyze and evaluate the skeletal muscle of patients affected with hemophilia in the Region of Murcia.

  • Describe the periarticular muscular deficit of the lower limbs, depending on the degree of injury: acute and chronic, or subacute.
  • Identify the range of motion of joints with higher prevalence of hemophilic arthropathy.
  • Detect the biomechanical changes 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2014

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 8, 2015

Status Verified

September 1, 2015

Enrollment Period

Same day

First QC Date

June 13, 2014

Last Update Submit

October 7, 2015

Conditions

Hemophilia

Keywords

HemophiliaArthropathyRange of MotionStrengthProprioceptionGaitQuality of Life

Outcome Measures

Primary Outcomes (11)

  • Assess the range of motion

    Assess the range of motion of elbow, knee and ankle (using a goniometric evaluation).

    Screening visit

  • Assess the muscular strength

    Assess the muscular strength of arm, thigh and leg (through measurement of muscle balance).

    Screening visit

  • Assess the joint pain

    Joint pain (VAS scale with the use of a pressure algometer).

    Screening visit

  • Assess the variables of strength

    Assessment of variables of vertical strength, medio-lateral and anterior-posterior in jump and incorporation from the sitting position.

    Screening visit

  • Assess the peak force

    Functional assessment of peak force, force production per unit time and subsequent stabilization in standing (in jump and in the passage from the sitting position to standing position, respectively, using a force platform).

    Screening visit

  • Assess the contractile activity

    Assessment of miotendinous contractile activity in the patellar tendon and Achilles, in jump (CMJ-stiffness test).

    Screening visit

  • Assess the state joint

    State joint (applying Hemophilia Joint Health Score questionnaire).

    Screening visit

  • Assess the list of activities

    List of activities in hemophilia (completing the autocuestionario Hemophilia Activities List).

    Screening visit

  • Assess the physical performance

    Perception of physical performance (with the HEP-Test-Q questionnaire)

    Screening visit

  • Assess the health Profile

    Health Profile (using the scale Nottingham health profile)

    Screening visit

  • Assess the quality of life

    Quality of life (using the SF-36 and Haemo-QoL-36 questionnaire).

    Screening visit

Secondary Outcomes (3)

  • Age, sex, weight of the patients with hemophilia

    Screening visit

  • Diagnosis, severity of hemophilia, type of treatment (prophylactic or on-demand) and inhibitors

    Screening visit

  • Frequency of joint bleeds in the previous month and bleeding during the assessment

    Screening visit

Study Arms (1)

Patients with hemophilia

Patients with hemophilia who meet the inclusion criteria

Eligibility Criteria

Age6 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from the Murcia Regional Hemophilia Association

You may qualify if:

  • Patients with hemophilia A and B
  • Patients of all ages (from 6 to 70 years).
  • With or without joint damage clinically diagnosed, and with or without a previous history of hemarthrosis joint load legs.
  • Residents in the Autonomous Community of the Region of Murcia.

You may not qualify if:

  • Patients without ambulation
  • Patients diagnosed with other congenital coagulopathy (von Willebrand disease, etc..).
  • Patients with neurological or cognitive impairments that prevent understanding the questionnaires and physical tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica San Antonio, Murcia

Murcia, Murcia, 30107, Spain

RECRUITING

MeSH Terms

Conditions

Hemophilia AJoint Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMusculoskeletal Diseases

Central Study Contacts

RUBÉN CUESTA-BARRIUSO, PhD

CONTACT

rcuesta@ucam.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 13, 2014

First Posted

June 17, 2014

Study Start

September 1, 2015

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

October 8, 2015

Record last verified: 2015-09

Locations

ES(1)