Resistance Training With Blood Flow Restriction in Hemophilia (HemoBFR)

The Acute and Chronic Impact of Blood Flow Restriction Resistance Training on Physical and Neuromuscular Function, Pain, and Quality of Life in Patients With Moderate/Severe Hemophilia

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.

Study Overview

• Status: Recruiting
• Conditions: Hemophilia
• Intervention / Treatment: Other: Control; Other: BFRT

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sofía Pérez Alenda; Phone Number: +34655382100; Email: sofia.perez-alenda@uv.es
• Study Contact Backup: Name: Joaquín Calatayud; Phone Number: +34625577509; Email: joaquin.calatayud@uv.es

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Recruiting
    • Facultat de Fisioteràpia
    • Contact: Sofía Pérez Alenda, PhD; Phone Number: +34655382100; Email: sofia.perez-alenda@uv.es
    • Contact: Joaquín Calatayud, PhD; Phone Number: +34625577509; Email: joaquin.calatayud@uv.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; 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; Moderate-to-high load (60%-80% 1RM) resistance exercise
Experimental: BFRT; 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; Low-load (30% 1RM) resistance exercise with blood flow restriction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)	Change from baseline to the end of the intervention, and the change between the intervention group and the control group.	Baseline and week 8.
Pressure pain thresholds (digital algometry)	Change from baseline to the end of the intervention, and the change between the intervention group and the control group.	Baseline and week 8.
Haemophilia Activities List (HAL) questionnaire	The HAL measures the impact of hemophilia on self-perceived functional abilities in adults. Its score range is 42-252, with higher scores representing more functional limitations.	Baseline and week 8.
A36 haemophilia quality of life (Hemofilia-QoL) questionnaire	A36 Hemofilia-QOL is a standardized disease specific questionnaire for the assessment of the health-related quality of life of people with haemophilia. The domains are physical health, daily activities, treatment satisfaction, mental aspects, relationships and social activities. There are 36 items and its score range is 0-144, with higher scores representing better outcomes.	Baseline and week 8.
Patient Global Impression of Change Scale (PGICS)	On this scale, the patient reflects the perception of the efficacy of the treatment received in their limitation to perform activities, symptoms, emotions and overall quality of life. The PGICS consists of two subscales, one categorical and one quantitative. The categorical scale is a 7-point verbal scale with the options "I have improved a lot" = 7, "I have improved a lot" = 6, "I have improved a little" = 5, "I am the same" = 4, "I have gotten a little worse" = 3, "I have gotten a lot worse" = 2, "I have gotten a lot worse" = 1. Meanwhile, the quantitative scale consists of a line from 0 to 10, where 0 = much better and 10 = much worse.	Baseline and week 8.

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Principal Investigator: Sofía Pérez Alenda, University of Valencia; Study Chair: Joaquín Calatayud, University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Electromyography; Resistance Training; Hemophilia; Muscle Activity
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A
• Other Study ID Numbers: Hemo-BFR-22-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No