HaemophiliaNCT04122014
Exercise Program to Improve Balance in Hemophilic Patients
A study testing Progressive balance training and Normal daily activities in people with Haemophilia, run by University of Valencia at 1 site in Spain.
Trial summary
This study evaluates the effectiveness of a program of physiotherapy exercises to train the balance and dual task in adults patients with hemophilia Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Haemophilia
- What is being tested?
- Progressive balance training and Normal daily activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2020to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Exercise Program to Improve Balance and Dual Task in Hemophilic Patients. Clinical Trial
This study evaluates the effectiveness of a program of physiotherapy exercises to train the balance and dual task in adults patients with hemophilia
Read the 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.
- Conditions
- Haemophilia
- Being tested
- Progressive balance training, Normal daily activities
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive balance trainingOther
Progressive balance training program
Normal daily activitiesOther
Usual daily activities
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Usual daily activities Receives: Other: Normal daily activities |
| Training group | Experimental | Each subject will participate in 2 sessions each week during 3 months. Receives: Other: Progressive balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and 3 months
Secondary outcomes (12)
Limits of Stability (LOS): success rate
Evaluations will be done by NedSVE/IBV balance platform. Indices: Max Excursions (%), Directional Control (%), Success (%), LOS rate (%) will be recorded during forward, backward, right and left side movements.
Measured: baseline and 3 months
Limits of Stability (LOS): time
Evaluations will be done by NedSVE/IBV balance platform. Indices: Reaction Time (s), Confinement Time (s), will be recorded during forward, backward, right and left side movements.
Measured: baseline and 3 months
The Berg Balance Scale
Balance will be assessed with the Berg Balance Scale (BBS), a 14-item physical performance measure of static and dynamic balance found to be reliable. Scoring ranges from 0-56, with higher scores indicating better balance. A score of <46 identifies an individual at risk for falls after stroke.
Measured: baseline and 3 months
Functional capacity: The Timed "Up & Go" test
Timed "Up \& Go" will be used to measure functional capacity. It is a simple test used to assess a person's mobility and requires both static and dynamic balance. Less time to complete the test in seconds implies better outcome.
Measured: baseline and 3 months
Functional capacity: Sit-to-stand test
Sit-to-stand test (3 repetitions) will be used to measure functional capacity. Less time to complete the test in seconds implies better outcome.
Measured: baseline and 3 months
Functional capacity: 2-minutes walk test
Evaluation of functional capacity during walking by using 2 minutes walk test. More distance covered in 2 minutes implies better outcome.
Measured: baseline and 3 months
Haemophilia Activities List (HAL)
The Haemophilia Activities List questionnaire measures the impact of hemophilia on self-perceived functional abilities in adults.
It contains 42 multiple choice questions in seven domains:
Lying/sitting/kneeling/standing (8 items) Functions of the legs (9 items) Functions of the arms (4 items) Use of transportation (3 items) Self-care (5 items) Household tasks (6 items) Leisure activities and sports (7 items) The most important outcomes are the overall sum score and three component scores relating to upper extremity activities, basic lower extremity activities, and complex lower extremity activities. The score is obtained using a Likert scale with 5 options: always=2, mostly=3, sometimes=4, rarely=5 and never=6 (complemented by the option "impossible=1" for those people who can not perform such activity). Subscales are summed, with a total score from 0- 252 and higher values represent a worse outcome (greater self-perceived difficulty in carrying out the activities).
Measured: baseline and 3 months
Functional Independence Scale for Hemophilia (FISH)
Observed activity limitations will be measured with the Functional Independence Scale for Hemophilia (FISH) as part of the Activity Domain.
The scale studies 8 activities (eating and grooming, bathing, dressing, chair, squatting, walking, stairs and running), which are classified into the three groups (Self care, Transfers and Locomotion) and their score ranges from 1 - 4 (1 being the highest dependency and 4 being the greatest independence to perform the exercises). Subscales are summed, with a total score from 8-32 and higher values represent a better outcome.
The FISH has been validated for use in developing countries. It consists of observed activities of daily living that are scored for quality.
Measured: baseline and 3 months
Quality of Life related with health: questionnaire
Measured by a Specific questionnaire for Quality of Life related with health evaluation for adults with haemophilia (A36Haemophilia-QoL), which explores 9 areas. Subscales and score range: Physical health: 0-32; Daily activities: 0-16; Joints: 0-12; Pain: 0-8; Treatment satisfaction: 0-8; Difficulties treatment: 0-16; Emotional functioning: 0-20; Mental health: 0-12; Social activity: 0-20. Subscales are summed, with a total score from 0-144 and higher values represent a better outcome (more Quality of Life perceived).
Measured: baseline and 3 months
Kinesiophobia
Kinesiophobia will be evaluated by Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz P., 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
Measured: baseline and 3 months
Modified Falls Efficacy Scale (mFES)
MFES is a 14-item questionnaire related to daily indoor and outdoor physical activities. It is a 10-point visual analog scale of confidence level in completing a particular activity (item) without falling, rated from 0 to 10, where 0 denotes not confident or sure at all, and 10 denotes completely confident or sure. The total score for the 14 items ranges from 0 to 140.
Measured: baseline and 3 months
Joint health status
Joint clinical evaluation of elbows, knees and ankles by using The Hemophilia Joint Health Score 2.1 (HJHS). The full score range goes from 0 to 124 points (0-20 points for each of the six joints evaluated, plus 4 points for the overall assessment of gait. 0 means no joint damage, whereas the higher the value, the higher the degree of arthropathy.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start10 Jan 2020
- Primary completionJun 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HaemophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Querol Fuentes, University of Valencia
- Investigators
- Felipe Querol-Fuentes, MD, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122014
- Sponsor's protocol ID
- H20190326180948
- Status last verified
- Jan 2020
- First submitted
- 24 Jul 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40153408
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Exercise Program to Improve Balance and Dual Task in Hemophilic Patients. Clinical Trial
- ClinicalTrials.gov ID
- NCT04122014
- Acronym / sponsor ID
- H20190326180948
- Conditions
- Haemophilia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Other: Normal daily activitiesUsual daily activities |
| Training group | Experimental | Other: Progressive balance trainingEach subject will participate in 2 sessions each week during 3 months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive balance trainingProgressive balance training program | Other | Training group |
| Normal daily activitiesUsual daily activities | Other | Control group |
Primary outcome
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 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: 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 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.
12 secondary outcomes
Limits of Stability (LOS): success rate
Time frame: baseline and 3 months
Limits of Stability (LOS): time
Time frame: baseline and 3 months
The Berg Balance Scale
Time frame: baseline and 3 months
Functional capacity: The Timed "Up & Go" test
Time frame: baseline and 3 months
Functional capacity: Sit-to-stand test
Time frame: baseline and 3 months
Functional capacity: 2-minutes walk test
Time frame: baseline and 3 months
Haemophilia Activities List (HAL)
Time frame: baseline and 3 months
Functional Independence Scale for Hemophilia (FISH)
Time frame: baseline and 3 months
Quality of Life related with health: questionnaire
Time frame: baseline and 3 months
Kinesiophobia
Time frame: baseline and 3 months
Modified Falls Efficacy Scale (mFES)
Time frame: baseline and 3 months
Joint health status
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Derived from this study: PubMed 40153408Chimeno-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe Querol-Fuentes, MD, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive balance training and Normal daily activities in people with Haemophilia, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of postural balance: amplitude of Center of Pressure (CoP) displacements (time frame: baseline and 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04122014, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.