Resistance Training With Blood Flow Restriction in Hemophilia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hemophilia

Intervention / Treatment
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* Other: BFRT
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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<br>* Moderate-to-high load (60%-80% 1RM) resistance exercise<br>|
| Experimental: BFRT<br>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 at 50% 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<br>* Low-load (30% 1RM) resistance exercise with blood flow restriction<br>|

What is the study measuring?
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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 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemophilia, Electromyography, Muscle Activity, Resistance Training