Clinical trial NCT05039008: Restricting Blood Flow in Improving Muscle Strength in Patients With Hemophilic Arthropathy
Official title: Effectiveness of Physiotherapy Intervention by Restricting Blood Flow in Improving Muscle Strength in Patients With Hemophilic Arthropathy. Randomized Multicenter Clinical Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia
Keywords: Hemophilic arthropathy
Blood flow restriction
Physiotherapy
Muscular strength
Muscle activation
Chronic pain
Functionality
Quality of life
Lead sponsor: Investigación en Hemofilia y Fisioterapia
Sponsor class: NETWORK
First posted: 2021-09-09
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline hemarthrosis after treatment and at four weeks.
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Secondary outcomes:
measure: Change from baseline joint pain after treatment and at four weeks
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
measure: Change from baseline muscle strength after treatment and at four weeks
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
measure: Change from baseline joint status after treatment and at four weeks
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
measure: Change from baseline range of motion after treatment and at four weeks
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Rubén Cuesta-Barriuso
state: Asturias
Study officials:
affiliation: Universidad de Oviedo
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References: