Exercise Program to Improve Balance in Hemophilic Patients
Effectiveness of an Exercise Program to Improve Balance and Dual Task in Hemophilic Patients. Clinical Trial
1 other identifier
interventional
25
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2019
CompletedFirst Posted
Study publicly available on registry
October 10, 2019
CompletedStudy Start
First participant enrolled
January 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedJanuary 13, 2020
January 1, 2020
5 months
July 24, 2019
January 10, 2020
Conditions
Outcome Measures
Primary Outcomes (6)
Change of postural balance: amplitude of Center of Pressure (CoP) displacements
Amplitude of CoP displacements will be assessed in millimeters using a computerized balance system. Higher displacements indicate worse balance.
baseline and 3 months
Change of postural balance: velocity of Center of Pressure (CoP) displacements
Velocity of CoP displacements will be assessed in millimeters using a computerized balance system. Higher velocity indicate worse balance.
baseline and 3 months
Change of postural balance: sway area of Center of Pressure (CoP) displacements
Sway area of CoP displacements will be assessed in mm\^2 using a computerized balance system. Higher sway area indicate worse balance.
baseline and 3 months
Change of dual task balance: amplitude of Center of Pressure (CoP) displacements
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.
baseline and 3 months
Change of dual task balance: velocity of Center of Pressure (CoP) displacements
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.
baseline and 3 months
Change of dual task balance: sway area of Center of Pressure (CoP) displacements
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.
baseline and 3 months
Secondary Outcomes (12)
Limits of Stability (LOS): success rate
baseline and 3 months
Limits of Stability (LOS): time
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
- +7 more secondary outcomes
Study Arms (2)
Control group
EXPERIMENTALUsual daily activities
Training group
EXPERIMENTALEach subject will participate in 2 sessions each week during 3 months.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Valencia
Valencia, 46010, Spain
Related Publications (1)
Chimeno-Hernandez A, Perez-Alenda S, Cruz-Montecinos C, Carrasco JJ, Aguilar-Rodriguez M. Multimodal Exercise Program of Balance and Strength Improves Dynamic Balance, Strength and Functionality and Decreases the Risk of Falls in Adults With Haemophilia. Haemophilia. 2025 May;31(3):544-556. doi: 10.1111/hae.70040. Epub 2025 Mar 28.
PMID: 40153408DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felipe Querol-Fuentes, MD, PhD
University of Valencia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 24, 2019
First Posted
October 10, 2019
Study Start
January 10, 2020
Primary Completion
June 1, 2020
Study Completion
October 1, 2020
Last Updated
January 13, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share