HemophiliaNCT05039008
Restricting Blood Flow in Improving Muscle Strength in Patients With Hemophilic Arthropathy
A study testing Blood flow restriction in people with Hemophilia, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Background. The main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy. Objective. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hemophilia
- What is being tested?
- Blood flow restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 6 Sep 2023to 21 Dec 2023
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with hemophilia A and B
- Patients with a medical diagnosis of hemophilic ankle and knee arthropathy
- People over 18 years of age
- Patients on prophylactic or on-demand treatment regimen with FVIII / FIX concentrates
Who cannot join
- Patients with neurological or cognitive disorders that impede understanding of the test.
- Pain free patients
- Amputees, epileptics or patients with severe vision problems
- Patients who are receiving Physiotherapy treatment at the time of the study
- Patients who have not signed the informed consent document
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Physiotherapy Intervention by Restricting Blood Flow in Improving Muscle Strength in Patients With Hemophilic Arthropathy. Randomized Multicenter Clinical Study.
Background. The main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy.
Objective. To assess the safety and effectiveness of an intervention through blood flow restriction, regarding the frequency of bleeding and the improvement in the perception of muscle activation and strength, functionality, joint pain, joint status and the perception of quality of life in patients with hemophilic arthropathy. knee and ankle.
Read more
Study design. Randomized, multicenter, single-blind clinical study. Method. 20patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 3 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and range of motion (goniometer). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 4 weeks.
Expected results. Observe the safety of blood flow restriction in hemophilia patients. To analyze the efficacy of blood flow restriction in improving muscle strength, joint pain, range of motion, and joint damage in patients with hemophilic knee and ankle arthropathy.
- Conditions
- Hemophilia
- Being tested
- Blood flow restriction
- Keywords
- Hemophilic arthropathy, Blood flow restriction, Physiotherapy, Muscular strength, Muscle activation, Chronic pain, Functionality, Quality of life
- Medical subject headings
- Hemophilia A, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restrictionOther
The intervention protocol will be carried out under the same environmental conditions and, as far as possible, at the same time. The intervention will last 4 weeks, with a periodicity of 3 weekly sessions. In total there will be 12 sessions that will last between 15 and 30 minutes depending on the number of joints affected.
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction group | Experimental | The intervention will last 4 weeks, with a periodicity of 3 weekly sessions (34). In total there will be 12 sessions lasting between 15 and 30 minutes.
The exercises will be: squats, knee extension and heel elevation (performing 4 sets of 15 repetitions with 30 seconds of rest between sets). Receives: Other: Blood flow restriction |
| Control group | No intervention | The patients included in the control group will not receive any Physiotherapy intervention and will continue with their usual routine, being evaluated in the same periods as the rest of the patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline hemarthrosis after treatment and at four weeks.
A self-registration will be used to evaluate the frequency of bleeding, and thus the safety of the technique. This self-registration will be given to each patient at the beginning of the study and they must fill in the number of hemarthrosis and their main characteristics: date, origin (traumatic or spontaneous) and location (knee or ankle). The self-registration will be delivered to the evaluator in each of the study evaluations (post-treatment and follow-up).
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Secondary outcomes (4)
Change from baseline joint pain after treatment and at four weeks
The visual analog scale will be used to assess the perception of joint pain, being valued with a range of 0 to 10 points (from no pain to the maximum pain suffered or imaginable) in the joints evaluated
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Change from baseline muscle strength after treatment and at four weeks
With a pressure dynamometer (microFET®2 Digital Handheld model) we will measure the strength of the quadriceps and triceps surae. This device measures in Newton the force that the patient exerts in the requested muscular action. The higher the value, the greater the muscle strength. We will carry out the measurements bilaterally. The patient will be asked 4 maximum isometric contractions of 5 seconds, with a rest of 30 seconds between them, against the dynamometer located in the hand of the evaluator
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Change from baseline joint status after treatment and at four weeks
Change from knee and ankle joint status during treatment and follow-up period at four weeks. Measurement instrument: Haemophilia Joint Health Score (scale 0-20).
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Change from baseline range of motion after treatment and at four weeks
Change from range of movement of knee and ankle during treatment and follow-up period at four weeks. The range of motion of the knee and ankle joint will be measured using a universal goniometer, using the protocol for measuring joint motion described by the American Academy of Orthopaedic Surgeons.
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start6 Sep 2023
- Primary completion14 Nov 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad de Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039008
- Sponsor's protocol ID
- He-Blood
- Status last verified
- Feb 2024
- First submitted
- 1 Sep 2021
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physiotherapy Intervention by Restricting Blood Flow in Improving Muscle Strength in Patients With Hemophilic Arthropathy. Randomized Multicenter Clinical Study.
- ClinicalTrials.gov ID
- NCT05039008
- Acronym / sponsor ID
- He-Blood
- Conditions
- Hemophilia
- Keywords
- Hemophilic arthropathy, Blood flow restriction, Physiotherapy, Muscular strength, Muscle activation, Chronic pain, Functionality, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 9 Sep 2021 (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.
Background. The main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy.
Objective. To assess the safety and effectiveness of an intervention through blood flow restriction, regarding the frequency of bleeding and the improvement in the perception of muscle activation and strength, functionality, joint pain, joint status and the perception of quality of life in patients with hemophilic arthropathy. knee and ankle.
Study design. Randomized, multicenter, single-blind clinical study. Method. 20patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 3 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and range of motion (goniometer). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 4 weeks.
Expected results. Observe the safety of blood flow restriction in hemophilia patients. To analyze the efficacy of blood flow restriction in improving muscle strength, joint pain, range of motion, and joint damage in patients with hemophilic knee and ankle arthropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction group | Experimental | Other: Blood flow restrictionThe intervention will last 4 weeks, with a periodicity of 3 weekly sessions (34). In total there will be 12 sessions lasting between 15 and 30 minutes. The exercises will be: squats, knee extension and heel elevation (performing 4 sets of 15 repetitions with 30 seconds of rest between sets). |
| Control group | No intervention | –The patients included in the control group will not receive any Physiotherapy intervention and will continue with their usual routine, being evaluated in the same periods as the rest of the patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with hemophilia A and B
- Patients with a medical diagnosis of hemophilic ankle and knee arthropathy
- People over 18 years of age
- Patients on prophylactic or on-demand treatment regimen with FVIII / FIX concentrates
Key exclusion criteria (5 listed)
- Patients with neurological or cognitive disorders that impede understanding of the test.
- Pain free patients
- Amputees, epileptics or patients with severe vision problems
- Patients who are receiving Physiotherapy treatment at the time of the study
- Patients who have not signed the informed consent document
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 |
|---|---|---|
| Blood flow restrictionThe intervention protocol will be carried out under the same environmental conditions and, as far as possible, at the same time. The intervention will last 4 weeks, with a periodicity of 3 weekly sessions. In total there will be 12 sessions that will last between 15 and 30 minutes depending on the number of joints affected. | Other | Blood flow restriction group |
Primary outcome
Change from baseline hemarthrosis after treatment and at four weeks.
Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
A self-registration will be used to evaluate the frequency of bleeding, and thus the safety of the technique. This self-registration will be given to each patient at the beginning of the study and they must fill in the number of hemarthrosis and their main characteristics: date, origin (traumatic or spontaneous) and location (knee or ankle). The self-registration will be delivered to the evaluator in each of the study evaluations (post-treatment and follow-up).
4 secondary outcomes
Change from baseline joint pain after treatment and at four weeks
Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Change from baseline muscle strength after treatment and at four weeks
Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Change from baseline joint status after treatment and at four weeks
Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Change from baseline range of motion after treatment and at four weeks
Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up 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 9 Feb 2024.
- 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
Universidad de Oviedo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction in people with Hemophilia, run by Investigación en Hemofilia y Fisioterapia 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 4 inclusion and 5 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 9 Feb 2024. 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?
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 hemarthrosis after treatment and at four weeks. (time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit). 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 9 Feb 2024.