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

Hemophilia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06261593
• Other study ID #: Ankle-Blood
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2024
• Est. completion date: September 20, 2024

Study information

• Verified date: February 2024
• Source: Investigación en Hemofilia y Fisioterapia
• Contact: Rubén Cuesta-Barriuso, PhD
• Phone: 607547274
• Email: cuestaruben[@]uniovi.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: September 20, 2024
• Est. primary completion date: July 3, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A
• Joint Diseases

Intervention

Other:
• Blood flow restriction
The intervention protocol through blood flow restriction in patients with hemophilic arthropathy will consist of performing two exercises: heel elevation and ankle dorsiflexion in a closed kinetic chain. Both exercises will be performed for 5-10 minutes, performing 4 series (30, 15, 15, 15 repetitions) with 30 seconds of rest between series

Locations

Country	Name	City	State
Spain	University of Oviedo	Oviedo	Asturias

Sponsors (1)

Lead Sponsor	Collaborator
Investigación en Hemofilia y Fisioterapia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline hemarthrosis after treatment and at 4 weeks	A self-registration will be used to evaluate the frequency of bleeding, and thus the safety of the technique. This selfregistration 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, ankle or elbow). The selfregistration 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
Secondary	Change from baseline pressure pain threshold after treatment and at 4 weeks	With a pressure algometer (model Wagner FPN100) the investigators 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 the investigators will increase at an approximate speed of 50kPa / s until the patient warns us that the sensation begins to be painful.	Screening visit, within the first seven days after treatment and after four weeks follow-up
Secondary	Change from baseline muscle strength after treatment and at 4 weeks	With a pressure dynamometer (microFET®2 Digital Handheld model) the investigators will measure the strength of the tibialis and gastrocnemius. 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. The investigators 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
Secondary	Change from baseline electrical activity of the muscles after treatment and at 4 weeks	Using surface electromyography (model SHIMMMER2, Shimmer, Ireland), the investigators 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.	Screening visit, within the first seven days after treatment and after four weeks follow-up
Secondary	Change from baseline joint status after treatment and at 4 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	Screening visit, within the first seven days after treatment and after four weeks follow-up
Secondary	Change from baseline range of motion after treatment and at four weeks	Change from range of movement of ankle during treatment and follow-up period at four weeks. The range of motion of the 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
Secondary	Change from baseline balance after treatment and at four weeks	With the Single Leg Stance Test, static postural control and balance will be evaluated. To perform this test, the subject must place both hands on the hips and flex the knee of the non-tested leg, leaving the opposite foot as the only support. The time will be timed (in seconds) from the moment the participant flexes his leg until he places it on the ground again or his hands come off his hips, with a maximum of 60 seconds. This test will be performed with visual support (eyes open) and without it (eyes closed). The longer the time, the better stability. The participants in this study will perform the test twice with each leg, with the best score recorded in the data analysis.	Screening visit, within the first seven days after treatment and after four weeks follow-up