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Clinical Trials/NCT04122014
NCT04122014
Unknown
N/A

Effectiveness of an Exercise Program to Improve Balance and Dual Task in Hemophilic Patients. Clinical Trial

University of Valencia1 site in 1 country25 target enrollmentJanuary 10, 2020
ConditionsHaemophilia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Haemophilia
Sponsor
University of Valencia
Enrollment
25
Locations
1
Primary Endpoint
Change of postural balance: amplitude of Center of Pressure (CoP) displacements
Last Updated
6 years ago

Overview

Brief Summary

This study evaluates the effectiveness of a program of physiotherapy exercises to train the balance and dual task in adults patients with hemophilia

Detailed Description

The objective of the study is to create an exercise program to improve the static and dynamic balance in hemophilic patient. In addition, the effect of the exercise program on dual task, functionality, proprioception, QoL, risk of falls and the kinesiophobia will be analyzed.

Registry
clinicaltrials.gov
Start Date
January 10, 2020
End Date
October 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Felipe Querol Fuentes

Principal Investigator

University of Valencia

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of haemophilia A or B
  • Willingness to exercise twice a week during the training program and to complete the pre- and post-program evaluations
  • Approval by their hematologist to participate in the exercise program
  • With hemostatic coverage supervised by your hematologist.
  • Age between 18 and 60 years
  • Informed consent signed.

Exclusion Criteria

  • Non adherence to instruction on proper exercise technique
  • Surgical procedures performed 6 months prior to or during the exercise program
  • A major bleeding episode that posed a risk or prevented exercise
  • Need for major surgery
  • Suffer from dizziness
  • Withdrawal of informed consent
  • Acquired hemophilia

Outcomes

Primary Outcomes

Change of postural balance: amplitude of Center of Pressure (CoP) displacements

Time Frame: baseline and 3 months

Amplitude of CoP displacements will be assessed in millimeters using a computerized balance system. Higher displacements indicate worse balance.

Change of dual task balance: amplitude of Center of Pressure (CoP) displacements

Time Frame: baseline and 3 months

Amplitude of CoP displacements will be assessed in millimeters using a computerized balance system. Patient will perform a cognitive task (e.g. counting) while maintaining balance. Higher displacements indicate worse balance.

Change of postural balance: velocity of Center of Pressure (CoP) displacements

Time Frame: baseline and 3 months

Velocity of CoP displacements will be assessed in millimeters using a computerized balance system. Higher velocity indicate worse balance.

Change of postural balance: sway area of Center of Pressure (CoP) displacements

Time Frame: baseline and 3 months

Sway area of CoP displacements will be assessed in mm\^2 using a computerized balance system. Higher sway area indicate worse balance.

Change of dual task balance: velocity of Center of Pressure (CoP) displacements

Time Frame: baseline and 3 months

Velocity of CoP displacements will be assessed in millimeters using a computerized balance system. Patient will perform a cognitive task (e.g. counting) while maintaining balance. Higher velocity indicate worse balance.

Change of dual task balance: sway area of Center of Pressure (CoP) displacements

Time Frame: baseline and 3 months

Sway area of CoP displacements will be assessed in mm\^2 using a computerized balance system. Patient will perform a cognitive task (e.g. counting) while maintaining balance. Higher sway area indicate worse balance.

Secondary Outcomes

  • Functional capacity: 2-minutes walk test(baseline and 3 months)
  • Kinesiophobia(baseline and 3 months)
  • Modified Falls Efficacy Scale (mFES)(baseline and 3 months)
  • The Berg Balance Scale(baseline and 3 months)
  • Functional capacity: The Timed "Up & Go" test(baseline and 3 months)
  • Functional capacity: Sit-to-stand test(baseline and 3 months)
  • Limits of Stability (LOS): success rate(baseline and 3 months)
  • Limits of Stability (LOS): time(baseline and 3 months)
  • Haemophilia Activities List (HAL)(baseline and 3 months)
  • Functional Independence Scale for Hemophilia (FISH)(baseline and 3 months)
  • Quality of Life related with health: questionnaire(baseline and 3 months)
  • Joint health status(baseline)

Study Sites (1)

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