Blood Flow Restriction in Improving Muscle Strength of Patients With Hemophilic Ankle Arthropathy

Investigación en Hemofilia y Fisioterapia

Status: Completed

Conditions: Hemophilia

Treatments: Other: Blood flow restriction

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06261593

Ankle-Blood

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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29 participants in 2 patient groups

Experimental group

Experimental group

Description:

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.

Treatment:

Other: Blood flow restriction

Control group

No Intervention group

Description:

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