Hemophilia
Conditions
Keywords
Hemophilia, Therapeutic exercise, Physical therapy, Randomized controlled trial, Pain perception, Range of movement
Brief summary
Objectives: To assess the efficacy of performing a therapeutic exercise program, compared with usual care, on pain relief, range of movement and self-perceived quality of life in patients with hemophilia Design: Quantitative, experimental, longitudinal and prospective study. Subjects: Male patients between 30 and 45 years old, with hemophilia type A or B and with knee, ankle or elbow arthropathy caused by hemophilia. Participants may be undergoing a pharmacologic treatment with intravenous VIII and/or IX factor Methods: Participants in the experimental group will an intervention based on therapeutic exercise. One therapist will instruct the patients during two sessions (each lasting approximately 1 hour). Participants will be asked to continue this program at least twice a week. Meanwhile, those in the control group will receive usual physical therapy care, based on a more passive approach, including self-assisted joint mobilization and muscle stretching. Those in the control group will be also instructed to perform the protocol at home, at least twice a week. The intervention protocol in both groups will last three months
Interventions
OTHERTherapeutic exercise
Patients will perform an exercise protocol specifically designed for patients with hemophilia that will include exercises focused on improving range of movement, strength, flexibility, balance and coordination as well as diaphragmatic breathing at the start and at the beginning of each session.
Patients will undergo usual physical therapy treatment for hemophiliacs, based on affected self and gentle joint mobilization and stretching of muscles involved in the affected joints.
Sponsors
University of Seville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
30 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of hemophilia type A or hemophilia type B. * Knee, elbow or ankle arthropathy caused by hemophilia * Pharmacological treatment based on using VIII or IX factor concentrates.
Exclusion criteria
* Presence of VIII FIX inhibitors. * Having received anti-inflammatory treatment using Arcoxia (Etoricoxib) * Having undergone a surgical intervention at the target joint. * Patients enrolled in other research which implies doing physical exercise.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pressure pain threshold (PPT) in the evaluated muscles. | Change from baseline to 3 months after intervention | The PPT levels will be evaluated in KPa. PPT levels, defined as the minimum necessary pressure to evoke pain will be evaluated using a handheld electronic pressure algometer. |
| Self-reported pain intensity: Numeric Pain Rating Scale (NPRS) | Change from baseline to 3 months after intervention | Self-reported pain will be evaluated using the Numeric Pain Rating Scale (NPRS), where 0 denotes no pain at all, and 10 denotes the maximum possible pain. |
| Range of movement (ROM). | Change from baseline to 3 months after intervention | Active ROM of the affected joint will be evaluated using inertial sensors, that measure lineal acceleration and angular velocity. |
| General flexibility | Change from baseline to 3 months after intervention | General flexibility will be assessed using the improved tot-flex test, which makes possible to extrapolate general flexibility from a combined movement measure. |
| Daily life activities | Change from baseline to 3 months after intervention | Ordinary daily life activities will be assessed using the Haemophilia Activities List, which measures the self-perceived functional state. |
| Self-perceived quality of life: A36 Haemophilia-QoL test | Change from baseline to 3 months after intervention | Quality of life will be evaluated using the A36 Haemophilia-QoL test. This is a valid and specific tool for hemophiliac adults. |
Countries
Spain
Outcome results
None listed