HaemophiliaNCT02825706
Educational Physiotherapy in Haemophilia
A study testing Educational physiotherapy group in people with Haemophilia, run by Real Fundación Victoria Eugenia.
Trial summary
Although arthropathy is a serious problem in patients with hemophilia due to the associated morbidity and incapacity, to the best of the investigators knowledge, no studies have looked at the effect of educational physiotherapy for its clinical improvement. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Haemophilia
- What is being tested?
- Educational physiotherapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Apr 2015
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with hemophilia A or B
- Patients over 18 years
- Patients with hemophilic arthropathy with at least 1 involved joint (elbow, knee or ankle)
- having signed the informed consent document.
Who cannot join
- Patients diagnosed with other congenital bleeding disorders (i.e. von Willebrand disease)
- Patients who developed antibodies to FVIII or FIX (inhibitors)
- Those not able to ambulate as a result of hemophilic arthropathy or any other disability
About this study
Official title: Effectiveness of an Educational Physiotherapy and Home Exercises Program in Adult Patients With Hemophilia: A Randomized Clinical Trial
Although arthropathy is a serious problem in patients with hemophilia due to the associated morbidity and incapacity, to the best of the investigators knowledge, no studies have looked at the effect of educational physiotherapy for its clinical improvement.
This contribution presents the results of educational physiotherapy program applied for 15 weeks with home exercises - in patients with hemophilic arthropathy. After treatment, experimental group showed improved a significant reduction of pain, and best quality of life al illness behaviour. During treatment no patient showed elbow haemarthrosis, which underlines the safety of this physiotherapy program.
- Conditions
- Haemophilia
- Being tested
- Educational physiotherapy group
- Keywords
- Hemophilia, Educational Physiotherapy, Pain, Quality of life, Illness Behaviour, Elbow
- Medical subject headings
- Hemophilia A, Pain, Illness Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational physiotherapy groupOther
20 patients with hemophilia were randomly allocated to an educational intervention or to a control group. The educational intervention was performed every two weeks during 15-week and home exercises were performed once a day, 6 days a week, in the same time
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The patients in experimental group received 60-minute educational sessions every two weeks about the pathophysiology of hemophilia, clinical manifestations, postural advice and prevention advice to avoid recurrent bleeding. Likewise, doubts on the clinical progress of hemophilic arthropathy, functional limitations and management of joint pain were resolved. In parallel with the educational sessions, patients followed a 15-week home exercise program performed once a day, 6 days a week. The program included muscle stretching exercises; isometric exercises; proprioceptive exercises on one leg with visual support; and a 20-minute walk. Low-intensity exercises with 20-25 repetitions were included. Receives: Other: Educational physiotherapy group |
| Control group | No intervention | The patients in the control group did not receive any educational sessions and did no exercise at all at home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline physical condition of joints after treatment and at 6 months
The physical condition of joints was assessed using the Gilbert scale that measures swelling, muscle atrophy, joint crepitus, range of motion, axial deformity and instability. Scores range from 0 to 12 (0 represents no joint injury and 12 represents maximum joint deterioration).
Measured: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline joint pain after treatment and at 6 months
Joint pain was assessed using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain at all) to 10 (the worst pain imaginable by the patient).
Measured: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline perception of the quality of life after treatment and at 6 months
The Haemophilia A-36 questionnaire was used to assess the perception of the quality of life. This questionnaire consists of 36 items that assess 9 domains (physical health, daily activities, joint damage and pain, treatment satisfaction, treatment difficulties, emotional functioning, mental health and social relationships).
Measured: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline illness behavior after treatment and at 6 months
To assess illness behavior, patients completed the Illness Behavior Questionnaire (IBQ). This scale consists of 62 items and 8 domains (hypochondriasis, disease conviction, psychological vs. somatic perception of illness, affective inhibition, affective disturbance, denial and irritability).
Measured: Screening visit, within the first seven days after treatment and after six months follow-up visit
Change from baseline frequency of bleedings after treatment and at 6 months
The frequency of bleeding is measured with a record which complete the patients, where they indicate the incidence of hematomas and hemarthrosis during the treatment and follow-up.
Measured: Screening visit, within the first seven days after treatment and after six months follow-up visit
Secondary outcomes (4)
Radiological joint deterioration
All patients had an assessment of radiological joint deterioration using the Pettersson scale. This scale, with scores ranging from 0 (a normal joint) to 13 (maximum joint deterioration), is the most widely used to assess joint degeneration produced by hemophilic arthropathy. The evaluation of radiological joint damage was done at the beginning of the study.
Measured: Screening visit
Age
Age of patients included in the study
Measured: Screening visit
Weight
Weight of the patients
Measured: Screening visit
Height
Height of patients
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startFeb 2012
- Primary completionOct 2012
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Real Fundación Victoria Eugenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Real Fundación Victoria Eugenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825706
- Sponsor's protocol ID
- EducationalPhys
- Status last verified
- Jul 2016
- First submitted
- 30 Jun 2016
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Educational Physiotherapy and Home Exercises Program in Adult Patients With Hemophilia: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02825706
- Acronym / sponsor ID
- EducationalPhys
- Conditions
- Haemophilia
- Keywords
- Hemophilia, Educational Physiotherapy, Pain, Quality of life, Illness Behaviour, Elbow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Real Fundación Victoria EugeniaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 Jul 2016 (estimated)
- 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.
Although arthropathy is a serious problem in patients with hemophilia due to the associated morbidity and incapacity, to the best of the investigators knowledge, no studies have looked at the effect of educational physiotherapy for its clinical improvement.
This contribution presents the results of educational physiotherapy program applied for 15 weeks with home exercises - in patients with hemophilic arthropathy. After treatment, experimental group showed improved a significant reduction of pain, and best quality of life al illness behaviour. During treatment no patient showed elbow haemarthrosis, which underlines the safety of this physiotherapy program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Educational physiotherapy groupThe patients in experimental group received 60-minute educational sessions every two weeks about the pathophysiology of hemophilia, clinical manifestations, postural advice and prevention advice to avoid recurrent bleeding. Likewise, doubts on the clinical progress of hemophilic arthropathy, functional limitations and management of joint pain were resolved. In parallel with the educational sessions, patients followed a 15-week home exercise program performed once a day, 6 days a week. The program included muscle stretching exercises; isometric exercises; proprioceptive exercises on one leg with visual support; and a 20-minute walk. Low-intensity exercises with 20-25 repetitions were included. |
| Control group | No intervention | –The patients in the control group did not receive any educational sessions and did no exercise at all at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with hemophilia A or B
- Patients over 18 years
- Patients with hemophilic arthropathy with at least 1 involved joint (elbow, knee or ankle)
- having signed the informed consent document.
Key exclusion criteria (3 listed)
- Patients diagnosed with other congenital bleeding disorders (i.e. von Willebrand disease)
- Patients who developed antibodies to FVIII or FIX (inhibitors)
- Those not able to ambulate as a result of hemophilic arthropathy or any other disability
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 |
|---|---|---|
| Educational physiotherapy group20 patients with hemophilia were randomly allocated to an educational intervention or to a control group. The educational intervention was performed every two weeks during 15-week and home exercises were performed once a day, 6 days a week, in the same time | Other | Experimental group |
Primary outcome
Change from baseline physical condition of joints after treatment and at 6 months
Time frame: Screening visit, within the first seven days after treatment and after six months follow-up visit
The physical condition of joints was assessed using the Gilbert scale that measures swelling, muscle atrophy, joint crepitus, range of motion, axial deformity and instability. Scores range from 0 to 12 (0 represents no joint injury and 12 represents maximum joint deterioration).
Change from baseline joint pain after treatment and at 6 months
Time frame: Screening visit, within the first seven days after treatment and after six months follow-up visit
Joint pain was assessed using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain at all) to 10 (the worst pain imaginable by the patient).
Change from baseline perception of the quality of life after treatment and at 6 months
Time frame: Screening visit, within the first seven days after treatment and after six months follow-up visit
The Haemophilia A-36 questionnaire was used to assess the perception of the quality of life. This questionnaire consists of 36 items that assess 9 domains (physical health, daily activities, joint damage and pain, treatment satisfaction, treatment difficulties, emotional functioning, mental health and social relationships).
Change from baseline illness behavior after treatment and at 6 months
Time frame: Screening visit, within the first seven days after treatment and after six months follow-up visit
To assess illness behavior, patients completed the Illness Behavior Questionnaire (IBQ). This scale consists of 62 items and 8 domains (hypochondriasis, disease conviction, psychological vs. somatic perception of illness, affective inhibition, affective disturbance, denial and irritability).
Change from baseline frequency of bleedings after treatment and at 6 months
Time frame: Screening visit, within the first seven days after treatment and after six months follow-up visit
The frequency of bleeding is measured with a record which complete the patients, where they indicate the incidence of hematomas and hemarthrosis during the treatment and follow-up.
4 secondary outcomes
Radiological joint deterioration
Time frame: Screening visit
Age
Time frame: Screening visit
Weight
Time frame: Screening visit
Height
Time frame: Screening visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- 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.
Rubén Cuesta-Barriuso, PhD principal investigator
Real Fundación Victoria Eugenia
Questions about this trial
What is this clinical trial studying?
A study testing Educational physiotherapy group in people with Haemophilia, run by Real Fundación Victoria Eugenia.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from baseline physical condition of joints after treatment and at 6 months (time frame: Screening visit, within the first seven days after treatment and after six months follow-up visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2016.