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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | 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. |
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| BFRT | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BFRT | Other | Low-load (30% 1RM) resistance exercise with blood flow restriction |
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| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SofÃa Pérez Alenda | University of Valencia | Principal Investigator |
| JoaquÃn Calatayud | University of Valencia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facultat de Fisioterà pia | Valencia | Valencia | 46010 | Spain |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Control |
| Other |
Moderate-to-high load (60%-80% 1RM) resistance exercise |
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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. |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |