Resistance Training With Blood Flow Restriction in Hemophilia

NCT05568524 | Completed

• 1 other identifier: Hemo-BFR-22-24
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of this study are to evaluate safety and chronic effects of a low-load resistance exercise intervention (elbow flexions and extensions, and knee extensions) with blood flow restriction in people with hemophilia on quality of life, pain, and on physical and neuromuscular function.

Conditions

Hemophilia

Keywords

Hemophilia; Electromyography; Muscle Activity; Resistance Training

Outcome Measures

Primary Outcomes (4)

• HDsEMG

  Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

  Baseline and week 8.

• Hand-held dynamometry (isometric elbow flexion/extension, knee extension)

  Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

  Baseline and week 8.

• Muscle ultrasound (muscle mass, assessment of possible bleedings)

  Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

  Baseline and week 8.

• Digital goniometry for active elbow and knee ROM

  Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

  Baseline and week 8.

Secondary Outcomes (5)

• Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)

  Baseline and week 8.

• Pressure pain thresholds (digital algometry)

  Baseline and week 8.

• Haemophilia Activities List (HAL) questionnaire

  Baseline and week 8.

• A36 haemophilia quality of life (Hemofilia-QoL) questionnaire

  Baseline and week 8.

• Patient Global Impression of Change Scale (PGICS)

  Baseline and week 8.

Study Arms (2)

Control

ACTIVE COMPARATOR

The training program for the control group consists of a telerehabilitation with traditional moderate-to-high load (60%-80% 1RM) exercises (the same as the intervention group sans BFR), utilizing elastic bands. This program for the control group will be conducted in an in-home real-time audio and video style and supervised by a physiotherapist.

Other: Control

BFRT

EXPERIMENTAL

The BFR training program for the intervention group consists of elbow flexion and extension, and knee extension exercises performed with low load (elastic bands; equivalent to 30% 1RM) and concurrent BFR (upper limb 50% AOP; lower limb 60% AOP). Subjects will perform 4 sets (30, 15, 15 and 15 reps) of each exercise with 30 s rest between sets and 5-minute rest between exercises.

Other: BFRT

Interventions

BFRT OTHER

Low-load (30% 1RM) resistance exercise with blood flow restriction

BFRT

Control OTHER

Moderate-to-high load (60%-80% 1RM) resistance exercise

Control

Eligibility Criteria

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

You may qualify if:

• diagnosis of hemophilia A or B and undergoing prophylaxis;
• willingness to exercise twice a week during the training program and to complete the pre- and post-program evaluations;
• approval by their hematologist to participate in the exercise program;
• age between 18 and 60 years;
• informed consent signed.

You may not qualify if:

• the inability to attend exercise sessions at least twice a week for 8 consecutive weeks;
• non adherence to instruction on proper exercise technique;
• surgical procedures performed 6 weeks prior to or during the exercise program; - participation in any other form of exercise, not previously done, during the study;
• changes in medication during the study;
• a major bleeding episode that posed a risk or prevented exercise;
• another hemostatic defect;
• need for major surgery;
• withdrawal of informed consent.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Facultat de Fisioteràpia

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Hemophilia A

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

Study Officials

• Sofía Pérez Alenda

  University of Valencia

  PRINCIPAL INVESTIGATOR

• Joaquín Calatayud

  University of Valencia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Faculty of Physiotherapy

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 5, 2022
• Study Start: January 15, 2024
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)