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

NCT05039008 | Completed

• 1 other identifier: He-Blood
• Study Type: interventional
• Target: 23
• 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 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. 20patients 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), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and range of motion (goniometer). 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, joint pain, range of motion, and joint damage in patients with hemophilic knee and ankle arthropathy.

Conditions

Hemophilia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Screening visit, within the first seven days after treatment and after four weeks follow-up visit

Secondary Outcomes (4)

• 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

• 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

• 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 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

Study Arms (2)

Blood flow restriction group

EXPERIMENTAL

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

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 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.

Blood flow restriction group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead

Study Sites (1)

Rubén Cuesta-Barriuso

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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 9, 2021
• Study Start: September 6, 2023
• Primary Completion: November 14, 2023
• Study Completion: December 21, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)