Hemophilia
Conditions
Keywords
Hemophilia, Electromyography, Muscle Activity, Resistance Training
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.
Interventions
OTHERBFRT
Low-load (30% 1RM) resistance exercise with blood flow restriction
OTHERControl
Moderate-to-high load (60%-80% 1RM) resistance exercise
Sponsors
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORSofía Pérez Alenda
University of Valencia
STUDY_CHAIRJoaquín Calatayud
University of Valencia
Outcome results
None listed