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

NCT06261632 | Active Not Recruiting

• 1 other identifier: Hemo-Blood
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hemophilia

Keywords

Hemophilic arthropathy; Blood flow restriction; Physiotherapy; Muscular strength; Muscle activation; Range of Motion; Chronic pain; Functionality; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Other: Blood flow restriction

Control group

NO INTERVENTION

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.

Interventions

Blood flow restriction OTHER

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead

Study Sites (1)

University of Oviedo

Oviedo, Principality of Asturias, 33006, Spain

Location

MeSH Terms

Conditions

Hemophilia A; Chronic Pain

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Rubén Cuesta-Barriuso, PhD

  Universidad de Oviedo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: February 19, 2024
• Primary Completion: July 28, 2024
• Study Completion: November 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)