Resistance Training with Blood Flow Restriction in Hemophilia

Not Applicable

Recruiting

• Conditions: Hemophilia

• Registration Number: NCT05568524
• Lead Sponsor: University of Valencia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-29
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-05
• Study Start: 2024-01-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Muscle ultrasound (muscle mass, assessment of possible bleedings)	Baseline and week 8.	Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
HDsEMG	Baseline and week 8.	Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
Hand-held dynamometry (isometric elbow flexion/extension, knee extension)	Baseline and week 8.	Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
Digital goniometry for active elbow and knee ROM	Baseline and week 8.	Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

Secondary Outcome Measures

Name	Time	Method
Haemophilia Activities List (HAL) questionnaire	Baseline and week 8.	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.
A36 haemophilia quality of life (Hemofilia-QoL) questionnaire	Baseline and week 8.	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.
Patient Global Impression of Change Scale (PGICS)	Baseline and week 8.	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.
Pressure pain thresholds (digital algometry)	Baseline and week 8.	Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)	Baseline and week 8.	Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

Trial Locations

Locations (1)

Facultat de Fisioteràpia; 🇪🇸 Valencia, Spain