Restricting Blood Flow in Improving Muscle Strength in Patients With Hemophilic Arthropathy

Sponsor

Investigación en Hemofilia y Fisioterapia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05039008

Collaborator

(none)

Enrollment

Arms

15.4

Anticipated Duration (Months)

Study Details

Study Description

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. 60 patients 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 and pressure algometer), quality of life (SF-36 scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and muscle activation (surface electromyograph) and functionality (6-Minutes Walking test, Quick

Disabilities of the arm, shoulder and hand). 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, chronic pain, functionality, and the perception of quality of life in patients with hemophilic knee and ankle arthropathy.

Condition or Disease	Intervention/Treatment	Phase
Hemophilia	Other: Blood flow restriction	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effectiveness of Physiotherapy Intervention by Restricting Blood Flow in Improving Muscle Strength in Patients With Hemophilic Arthropathy. Randomized Multicenter Clinical Study.

Anticipated Study Start Date :

Sep 15, 2022

Anticipated Primary Completion Date :

Jul 14, 2023

Anticipated Study Completion Date :

Dec 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Blood flow restriction group The intervention will last 4 weeks, with a periodicity of 3 weekly sessions (34). In total there will be 12 sessions lasting between 15 and 30 minutes. The exercises will be: squats, knee extension and heel elevation (performing 4 sets of 15 repetitions with 30 seconds of rest between sets).	Other: Blood flow restriction The intervention protocol will be carried out under the same environmental conditions and, as far as possible, at the same time. The intervention will last 4 weeks, with a periodicity of 3 weekly sessions. In total there will be 12 sessions that will last between 15 and 30 minutes depending on the number of joints affected.
No Intervention: Control group 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.

Arm

Intervention/Treatment

Experimental: Blood flow restriction group

The intervention will last 4 weeks, with a periodicity of 3 weekly sessions (34). In total there will be 12 sessions lasting between 15 and 30 minutes. The exercises will be: squats, knee extension and heel elevation (performing 4 sets of 15 repetitions with 30 seconds of rest between sets).

Other: Blood flow restriction

The intervention protocol will be carried out under the same environmental conditions and, as far as possible, at the same time. The intervention will last 4 weeks, with a periodicity of 3 weekly sessions. In total there will be 12 sessions that will last between 15 and 30 minutes depending on the number of joints affected.

No Intervention: Control group

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.

Outcome Measures

Primary Outcome Measures

Change from baseline hemarthrosis after treatment and at four weeks. [Screening visit, within the first seven days after treatment and after four weeks follow-up visit]
A 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).

Secondary Outcome Measures

Change from baseline joint pain after treatment and at four weeks [Screening visit, within the first seven days after treatment and after four weeks follow-up visit]
The visual analog scale will be used to assess the perception of joint pain, being valued with a range of 0 to 10 points (from no pain to the maximum pain suffered or imaginable) in the joints evaluated
Change from baseline pressure pain threshold after treatment and at four weeks [Screening visit, within the first seven days after treatment and after four weeks follow-up visit]
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).
Change from baseline muscle strength after treatment and at four weeks [Screening visit, within the first seven days after treatment and after four weeks follow-up visit]
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
Change from baseline electrical activity of the muscles after treatment and at four weeks [Screening visit, within the first seven days after treatment and after four weeks follow-up visit]
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.
Change from baseline perception of quality of life after treatment and at four weeks [Screening visit, within the first seven days after treatment and after four weeks follow-up visit]
Using the generic Short Form 36 (SF-36v2) scale, the perception of quality of life of the patients included in the study will be evaluated. This scale consists of 36 items and a range from 0 to 100 points (where a higher score indicates a better perception of quality of life).
Change from baseline joint status after treatment and at four weeks [Screening visit, within the first seven days after treatment and after four weeks follow-up visit]
Change from knee and ankle joint status during treatment and follow-up period at four weeks. Measurement instrument: Haemophilia Joint Health Score (scale 0-20).
Change from baseline range of motion after treatment and at four weeks [Screening visit, within the first seven days after treatment and after four weeks follow-up visit]
Change from range of movement of knee and ankle during treatment and follow-up period at four weeks. The range of motion of the knee and ankle joint will be measured using a universal goniometer, using the protocol for measuring joint motion described by the American Academy of Orthopaedic Surgeons.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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