Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood flow restriction | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Screening visit, within the first seven days after treatment and after four weeks follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Screening visit, within the first seven days after treatment and after four weeks follow-up visit |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rubén Cuesta-Barriuso, PhD | Universidad de Oviedo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rubén Cuesta-Barriuso | Oviedo | Principality of Asturias | 33006 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000090003 | Blood Flow Restriction Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 | 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). | 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. | Screening visit, within the first seven days after treatment and after four weeks follow-up visit |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |