Haemophilia
Conditions
Brief summary
This study evaluates the clinical impact of a progressive resistance training program in adults patients with haemophilia
Detailed description
The training program aims improving muscular strength and endurance in the relevant muscles and joints (knee, elbow, ankle, shoulder and hip) in order to improve the quality of life in the patients.
Interventions
OTHERProgressive resistance training
Progressive resistance training program
Usual daily activities
Sponsors
Shire
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of haemophilia A or B * 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 6 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, including rehabilitation, during the study; (5) changes in medication during the study * a major bleeding episode that posed a risk or prevented exercise * History of FVIII inhibitor (titer ≥ 0.6 BU \[Bethesda unit\]) or detectable FVIII inhibitors at screening (titer ≥ 0.4 BU) * Another haemostatic defect * Need for major surgery * Withdrawal of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Muscle strength | baseline and 8 weeks | For measuring the isometric knee flexion and extension, ankle plantarflexion and dorsiflexion strength and isometric elbow flexion and extension strength, a portable hand-held dynamometer will be used (Nicholas Manual Muscle Tester, Lafayette Instruments, Indiana, USA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Haemophilia Quality of life questionnaire (A36 Haemophilia-QoL® ) | baseline and 8 weeks | The Haemophilia-QoL questionnaire is a self-report modular instrument that assesses nine relevant HRQoL domains for patients with haemophilia (e.g. physical health, daily activities, joint damage, pain, treatment satisfaction, treatment difficulties, emotional functioning, mental health, relationships and social activity). |
| Change in Bleedings | daily (during the 8 weeks of intervention) | Number of Bleedings During the study |
| Change in viscoelastic properties (rectus femoris) | baseline and 8 weeks | Myoton Pro |
| Change in sit-to-stand test | baseline and 8 weeks | The time taken for the participant to stand up and sit down from a standard 45 cm chair with arms three times, as quickly as possible, was measured. |
| Change in Haemophilia Activities List questionnaire | baseline and 8 weeks | The Haemophilia Activities List questionnaire measures the impact of hemophilia on self-perceived functional abilities in adults. It contains 42 multiple choice questions in seven domains: Lying/sitting/kneeling/standing (8 items) Functions of the legs (9 items) Functions of the arms (4 items) Use of transportation (3 items) Self-care (5 items) Household tasks (6 items) Leisure activities and sports (7 items) The most important outcomes are the overall sum score and three component scores relating to upper extremity activities, basic lower extremity activities, and complex lower extremity activities. A domain score for each of the seven domains can also be calculated. |
| Change in Timed Up and Go | baseline and 8 weeks | The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. |
| Change in Pain | baseline and 8 weeks | 11-point numerical pain rating scale with higher score meaning higher pain |
| Change in workability index | baseline and 8 weeks | workability index with single question |
| Change in analgesics use (days/week) | baseline and 8 weeks | The number of days the participants used analgesics during the last week |
| Change in Range Of Motion (ROM) | baseline and 8 weeks | elbow extensio/flexion, ankle dorsiflexion/plantar flexion and knee flexion/extension ROM with a goniometer |
| Change in Kinesiophobia | baseline and 8 weeks | Tampa Scale of Kinesiophobia (TSK-11SV) used to assess changes in fear of movement |
| Change in The Haemophilia Joint Health Score (HJHS) | baseline and 8 weeks | The HJHS measures joint health, in the domain of body structure and function (i.e. impairment), of the joints most commonly affected by bleeding in hemophilia: the knees, ankles, and elbows.The HJHS 2.1 provides a total score (higher score is worse; max=124), joint specific scores, and a global gait score. |
Countries
Spain
Outcome results
None listed