HemophiliaNCT06261632
Blood Flow Restriction in Improving Muscle Strength of Patients With Hemophilic Knee 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 60 years, men only
- 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
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 19 Feb 2024to 1 Nov 2024
- 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
- Patients diagnosed with hemophilia A and B
- People with a medical diagnosis of hemophilic knee arthropathy
- Adults (> 18 years)
- In prophylactic treatment regimen or on demand with FVIII/FIX concentrates.
- Failure to sign the informed consent document
Who cannot join
- Patients with neurological or cognitive alterations that prevent understanding of the questionnaires
- Amputee patients, epileptics or patients with severe vision problems
- Patients who are receiving physiotherapy treatment at the time of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of a Physiotherapy Intervention Through Blood Flow Restriction in Improving Muscle Strength in Patients With Hemophilic Knee Arthropathy: Multicenter Randomized 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 muscle activation and strength, range of motion, 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. 60 patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 6 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale and pressure algometer), quality of life (SF-36 scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and muscle activation (surface electromyograph), range of motion (goniometer) and functionality (Timed up and go test). 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 and activation, range of motion, chronic pain, functionality, and the perception of quality of life 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, Range of Motion, 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 through blood flow restriction in patients with hemophilic arthropathy will include performing squats and knee extension for 5-10 and 10 minutes respectively. In both exercises, 4 series will be performed (30, 15, 15, 15 repetitions) with 30 seconds of rest between series
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The intervention will consist of carrying out a physiotherapy protocol, consisting of strength training through blood flow restriction, with an occlusion pressure of 40-50% of the LOP (Limb Occlusion Pressure) and a load of 20-30%. of 1RM performed ad hoc for patients with hemophilic arthropathy.
The intervention protocol will be carried out in person under the supervision of the main researcher. The intervention will last 4 weeks, with a frequency of 3 weekly sessions. In total there will be 12 sessions lasting approximately 30-45 minutes 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
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
Secondary outcomes (6)
Change from baseline pressure pain threshold after treatment and at four weeks
With a pressure algometer (model Wagner FPN100) we will measure the pressure pain threshold, at the joint level and at a distance (in another part of the body). This device measures in Newton / cm2 the pressure at which the subject perceives pain under pressure. A pressure will be made on the chosen point, which we will increase at an approximate speed of 50kPa / s until the patient warns us that the sensation begins to be painful. Hemophilic arthropathy will be assessed in the knee (inner edge of the patella) and ankle (lateral malleolus).
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up
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
Change from baseline electrical activity of the muscles after treatment and at four weeks
Using surface electromyography (model SHIMMMER2, Shimmer, Ireland), we will evaluate the electrical activity of the musculature and its level of activation. The placement of the electrodes will be marked on the standing subjects, and they will be placed following the European recommendations for the use of the SEMG. A bipolar SEMG system will be used with circular electrodes 10 mm in diameter, 20 mm apart, placed longitudinally, in the direction of the fibers of the studied muscle, and with a remote reference electrode
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up
Change from baseline range of motion after treatment and at four weeks
The range of motion of the knee 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
Change from baseline joint status after treatment and at four weeks
With the Hemophilia Joint Health Score scale, specific for its use in patients with hemophilia, the joint status of patients with hemophilic arthropathy will be evaluated. It evaluates 8 items: inflammation and duration of this, pain, muscle atrophy and strength, crackles, and loss of flexion and extension. It has a score of 0 (no joint damage) to 20 points (maximum joint damage) per joint (elbows, knees and ankles). A gait rating is added to the 120 points (range 0-4 points), the maximum rating on this scale being 124 points
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up
Change from baseline functionality after treatment and at four weeks
With the Timed Up and Go Test, basic mobility skills, strength, balance and agility will be evaluated. This test can help predict an individual's risk of falls and other adverse outcomes. This test measures the time it takes for a patient to get up from a chair (without using their arms to get up), walk to a line on the floor 3 m away, turn around, and return to the chair and sit down. Two measurements will be made per patient and the best value will be used for analysis. The unit of measurement is seconds, where the shorter the time, the better the score.
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start19 Feb 2024
- Primary completion28 Jul 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
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
- NCT06261632
- Sponsor's protocol ID
- Hemo-Blood
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 20 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Physiotherapy Intervention Through Blood Flow Restriction in Improving Muscle Strength in Patients With Hemophilic Knee Arthropathy: Multicenter Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06261632
- Acronym / sponsor ID
- Hemo-Blood
- Conditions
- Hemophilia
- Keywords
- Hemophilic arthropathy, Blood flow restriction, Physiotherapy, Muscular strength, Muscle activation, Range of Motion, Chronic pain, Functionality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 28 Jul 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 15 Feb 2024 (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 muscle activation and strength, range of motion, 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. 60 patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 6 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale and pressure algometer), quality of life (SF-36 scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and muscle activation (surface electromyograph), range of motion (goniometer) and functionality (Timed up and go test). 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 and activation, range of motion, chronic pain, functionality, and the perception of quality of life in patients with hemophilic knee and ankle arthropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Blood flow restrictionThe intervention will consist of carrying out a physiotherapy protocol, consisting of strength training through blood flow restriction, with an occlusion pressure of 40-50% of the LOP (Limb Occlusion Pressure) and a load of 20-30%. of 1RM performed ad hoc for patients with hemophilic arthropathy. The intervention protocol will be carried out in person under the supervision of the main researcher. The intervention will last 4 weeks, with a frequency of 3 weekly sessions. In total there will be 12 sessions lasting approximately 30-45 minutes |
| 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 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients diagnosed with hemophilia A and B
- People with a medical diagnosis of hemophilic knee arthropathy
- Adults (> 18 years)
- In prophylactic treatment regimen or on demand with FVIII/FIX concentrates.
- Failure to sign the informed consent document
Key exclusion criteria (3 listed)
- Patients with neurological or cognitive alterations that prevent understanding of the questionnaires
- Amputee patients, epileptics or patients with severe vision problems
- Patients who are receiving physiotherapy treatment at the time of the study
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 through blood flow restriction in patients with hemophilic arthropathy will include performing squats and knee extension for 5-10 and 10 minutes respectively. In both exercises, 4 series will be performed (30, 15, 15, 15 repetitions) with 30 seconds of rest between series | Other | Experimental 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
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).
6 secondary outcomes
Change from baseline pressure pain threshold after treatment and at four weeks
Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up
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
Change from baseline electrical activity of the muscles after treatment and at four weeks
Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up
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
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
Change from baseline functionality after treatment and at four weeks
Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 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 5 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: status not confirmed, as of the sponsor's last update on 20 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?
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 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). 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 20 Feb 2024.