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

Primary Purpose

Hemophilia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood flow restriction
Sponsored by
Investigación en Hemofilia y Fisioterapia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia focused on measuring Hemophilic arthropathy, Blood flow restriction, Physiotherapy, Muscular strength, Muscle activation, Chronic pain, Functionality, Quality of life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Blood flow restriction group

    Control group

    Arm Description

    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).

    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.

    Outcomes

    Primary Outcome Measures

    Change from baseline hemarthrosis after treatment and at four weeks.
    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
    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
    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
    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
    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
    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
    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
    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.

    Full Information

    First Posted
    September 1, 2021
    Last Updated
    March 29, 2022
    Sponsor
    Investigación en Hemofilia y Fisioterapia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05039008
    Brief Title
    Restricting Blood Flow in Improving Muscle Strength in Patients With Hemophilic Arthropathy
    Official Title
    Effectiveness of Physiotherapy Intervention by Restricting Blood Flow in Improving Muscle Strength in Patients With Hemophilic Arthropathy. Randomized Multicenter Clinical Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2022 (Anticipated)
    Primary Completion Date
    July 14, 2023 (Anticipated)
    Study Completion Date
    December 28, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Investigación en Hemofilia y Fisioterapia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemophilia
    Keywords
    Hemophilic arthropathy, Blood flow restriction, Physiotherapy, Muscular strength, Muscle activation, Chronic pain, Functionality, Quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Blood flow restriction group
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    Blood flow restriction
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change from baseline hemarthrosis after treatment and at four weeks.
    Description
    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).
    Time Frame
    Screening visit, within the first seven days after treatment and after four weeks follow-up visit
    Secondary Outcome Measure Information:
    Title
    Change from baseline joint pain after treatment and at four weeks
    Description
    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
    Time Frame
    Screening visit, within the first seven days after treatment and after four weeks follow-up visit
    Title
    Change from baseline pressure pain threshold after treatment and at four weeks
    Description
    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).
    Time Frame
    Screening visit, within the first seven days after treatment and after four weeks follow-up visit
    Title
    Change from baseline muscle strength after treatment and at four weeks
    Description
    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
    Time Frame
    Screening visit, within the first seven days after treatment and after four weeks follow-up visit
    Title
    Change from baseline electrical activity of the muscles after treatment and at four weeks
    Description
    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.
    Time Frame
    Screening visit, within the first seven days after treatment and after four weeks follow-up visit
    Title
    Change from baseline perception of quality of life after treatment and at four weeks
    Description
    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).
    Time Frame
    Screening visit, within the first seven days after treatment and after four weeks follow-up visit
    Title
    Change from baseline joint status after treatment and at four weeks
    Description
    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).
    Time Frame
    Screening visit, within the first seven days after treatment and after four weeks follow-up visit
    Title
    Change from baseline range of motion after treatment and at four weeks
    Description
    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.
    Time Frame
    Screening visit, within the first seven days after treatment and after four weeks follow-up visit

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rubén Cuesta-Barriuso, PhD
    Phone
    +34 913146508
    Email
    ruben.cuestab@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rubén Cuesta-Barriuso, PhD
    Organizational Affiliation
    Universidad de Murcia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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