Clinical trial NCT04122014: Exercise Program to Improve Balance in Hemophilic Patients
Official title: Effectiveness of an Exercise Program to Improve Balance and Dual Task in Hemophilic Patients. Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Haemophilia
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of postural balance: amplitude of Center of Pressure (CoP) displacements
timeFrame: baseline and 3 months
measure: Change of postural balance: velocity of Center of Pressure (CoP) displacements
timeFrame: baseline and 3 months
measure: Change of postural balance: sway area of Center of Pressure (CoP) displacements
timeFrame: baseline and 3 months
measure: Change of dual task balance: amplitude of Center of Pressure (CoP) displacements
timeFrame: baseline and 3 months
measure: Change of dual task balance: velocity of Center of Pressure (CoP) displacements
timeFrame: baseline and 3 months
measure: Change of dual task balance: sway area of Center of Pressure (CoP) displacements
timeFrame: baseline and 3 months
Secondary outcomes:
measure: Limits of Stability (LOS): success rate
timeFrame: baseline and 3 months
measure: Limits of Stability (LOS): time
timeFrame: baseline and 3 months
measure: The Berg Balance Scale
timeFrame: baseline and 3 months
measure: Functional capacity: The Timed "Up & Go" test
timeFrame: baseline and 3 months
measure: Functional capacity: Sit-to-stand test
timeFrame: baseline and 3 months
measure: Functional capacity: 2-minutes walk test
timeFrame: baseline and 3 months
measure: Haemophilia Activities List (HAL)
timeFrame: baseline and 3 months
measure: Functional Independence Scale for Hemophilia (FISH)
timeFrame: baseline and 3 months
measure: Quality of Life related with health: questionnaire
timeFrame: baseline and 3 months
measure: Kinesiophobia
timeFrame: baseline and 3 months
measure: Modified Falls Efficacy Scale (mFES)
timeFrame: baseline and 3 months
measure: Joint health status
timeFrame: baseline
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: University of Valencia
name: Felipe Querol-Fuentes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: