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

Hemophilia Clinical Trial

Official title:

Safety and Efficacy of a Physiotherapy Intervention Through Blood Flow Restriction in Improving Muscle Strength in Patients With Hemophilic Knee Arthropathy: Multicenter Randomized Clinical Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06261632
• Other study ID #: Hemo-Blood
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: February 2024
• Source: Investigación en Hemofilia y Fisioterapia
• Contact: n/a
• 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, 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. 60 patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 6 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 functionality (Timed up and go 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, functionality, and the perception of quality of life in patients with hemophilic knee and ankle arthropathy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: November 1, 2024
• Est. primary completion date: July 28, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with hemophilia A and B

• People with a medical diagnosis of hemophilic knee arthropathy

• Adults (> 18 years)

• In prophylactic treatment regimen or on demand 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
• Joint Diseases

Intervention

Other:
• Blood flow restriction
The intervention protocol through blood flow restriction in patients with hemophilic arthropathy will include performing squats and knee extension for 5-10 and 10 minutes respectively. In both exercises, 4 series will be performed (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 four weeks	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
Secondary	Change from baseline pressure pain threshold after treatment and at four weeks	With a pressure algometer (model Wagner FPN100) we 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 we will increase at an approximate speed of 50kPa / s until the patient warns us that the sensation begins to be painful. Hemophilic arthropathy will be assessed in the knee (inner edge of the patella) and ankle (lateral malleolus).	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 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
Secondary	Change from baseline electrical activity of the muscles after treatment and at four weeks	Using surface electromyography (model SHIMMMER2, Shimmer, Ireland), we 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 range of motion after treatment and at four weeks	The range of motion of the knee 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 joint status after treatment and at four 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 functionality after treatment and at four weeks	With the Timed Up and Go Test, basic mobility skills, strength, balance and agility will be evaluated. This test can help predict an individual's risk of falls and other adverse outcomes. This test measures the time it takes for a patient to get up from a chair (without using their arms to get up), walk to a line on the floor 3 m away, turn around, and return to the chair and sit down. Two measurements will be made per patient and the best value will be used for analysis. The unit of measurement is seconds, where the shorter the time, the better the score.	Screening visit, within the first seven days after treatment and after four weeks follow-up