Resistance Training With Blood Flow Restriction in Hemophilia

Hemophilia Clinical Trial

— HemoBFR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05568524
• Other study ID #: Hemo-BFR-22-24
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: University of Valencia
• Contact: Sofía Pérez Alenda
• Phone: +34655382100
• Email: sofia.perez-alenda[@]uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A

Intervention

Other:
• BFRT
Low-load (30% 1RM) resistance exercise with blood flow restriction
• Control
Moderate-to-high load (60%-80% 1RM) resistance exercise

Locations

Country	Name	City	State
Spain	Facultat de Fisioteràpia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.