HemoBFR: Resistance Training With Blood Flow Restriction in Hemophilia
Study Details
Study Description
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 shoulder abductions) with blood flow restriction in people with hemophilia on quality of life, pain, and on physical and neuromuscular function.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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 shoulder abduction exercises performed with low load (elastic bands; equivalent to 30% 1RM) and concurrent BFR at 40% 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
|
Outcome Measures
Primary Outcome Measures
- 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, shoulder abduction) [Baseline and week 8.]
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
- Muscle ultrasound (muscle mass, quality; 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.
- Digital goniometry for active elbow 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
- 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.
- 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.
- Hand dynamometry (handgrip strength) [Baseline and week 8.]
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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diagnosis of hemophilia A or B and undergoing prophylaxis;
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willingness to exercise twice a week during the training program and to complete the pre- and post-program evaluations;
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approval by their hematologist to participate in the exercise program;
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age between 18 and 60 years;
-
informed consent signed.
Exclusion Criteria:
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the inability to attend exercise sessions at least twice a week for 8 consecutive weeks;
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non adherence to instruction on proper exercise technique;
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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;
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changes in medication during the study;
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a major bleeding episode that posed a risk or prevented exercise;
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another hemostatic defect;
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need for major surgery;
-
withdrawal of informed consent.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Valencia
Investigators
- Principal Investigator: Sofía Pérez Alenda, University of Valencia
- Study Chair: Joaquín Calatayud, University of Valencia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Hemo-BFR-22-24