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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Facultat de Fisioteràpia
Valencia, Valencia, Spain
HDsEMG
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and week 8.
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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: Baseline and week 8.