Clinical trial NCT06261593: Blood Flow Restriction in Improving Muscle Strength of Patients With Hemophilic Ankle Arthropathy
Official title: Efficacy of a Physiotherapy Intervention Through Blood Flow Restriction in Improving Muscle Strength in Patients With Hemophilic Ankle Arthropathy: Multicenter Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia
Keywords: Hemophilia
Blood flow restriction
Physiotherapy
Muscular strength
Muscle activation
Range of Motion
Chronic pain
Stability
Lead sponsor: Investigación en Hemofilia y Fisioterapia
Sponsor class: NETWORK
First posted: 2024-02-15
Enrollment: 29
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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 muscle activation and strength, range of motion, stability, joint pain, joint status and the perception of quality of life in patients with hemophilic ankle arthropathy.

Study design. Randomized, multicenter, single-blind clinical study. Method. 32 patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 4 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 stability (The Single Leg Stance 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, stabilit, and the perception of quality of life in patients with hemophilic ankle arthropathy.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with hemophilia A and B
* People with a medical diagnosis of hemophilic ankle arthropathy
* Patients over 18 years of age
* Paceinets in prophylactic or on-demand treatment regimen with FVIII/FIX concentrates.
* Failure to sign the informed consent document

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline hemarthrosis after treatment and at 4 weeks
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up
Secondary outcomes:
measure: Change from baseline pressure pain threshold after treatment and at 4 weeks
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up
measure: Change from baseline muscle strength after treatment and at 4 weeks
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up
measure: Change from baseline electrical activity of the muscles after treatment and at 4 weeks
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up
measure: Change from baseline joint status after treatment and at 4 weeks
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up
measure: Change from baseline balance after treatment and at four weeks
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: University of Oviedo
state: Asturias
Study officials:
affiliation: Universidad de Oviedo
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References: