A Progressive Resistance Training Program in Patients With Haemophilia

Study Overview
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Brief Summary
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This study evaluates the clinical impact of a progressive resistance training program in adults patients with haemophilia

Detailed Description
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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.

Official Title
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The Impact of Progressive Resistance Training on Quality of Life in Patients With Haemophilia

Conditions
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Haemophilia

Intervention / Treatment
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* Other: Progressive resistance training
* Other: Normal daily activities


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training group<br>Each subject will participate in 2 sessions each week during 8 weeks, with 3 days of difference (rest) between the sessions. | Other: Progressive resistance training<br>* Progressive resistance training program<br>|
| Placebo Comparator: Control group<br>Usual daily activities | Other: Normal daily activities<br>* Usual daily activities<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Muscle strength | 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). | baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Timed Up and Go | 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. | baseline and 8 weeks | 
| Change in Haemophilia Quality of life questionnaire (A36 Haemophilia-QoL® ) | 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). | baseline and 8 weeks | 
| Change in Bleedings | Number of Bleedings During the study | daily (during the 8 weeks of intervention) | 
| Change in viscoelastic properties (rectus femoris) | Myoton Pro | baseline and 8 weeks | 
| Change in sit-to-stand test | 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. | baseline and 8 weeks | 
| Change in Haemophilia Activities List questionnaire | 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. | baseline and 8 weeks | 
| Change in The Haemophilia Joint Health Score (HJHS) | 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. | baseline and 8 weeks | 
| Change in Pain | 11-point numerical pain rating scale with higher score meaning higher pain | baseline and 8 weeks | 
| Change in workability index | workability index with single question | baseline and 8 weeks | 
| Change in analgesics use (days/week) | The number of days the participants used analgesics during the last week | baseline and 8 weeks | 
| Change in Range Of Motion (ROM) | elbow extensio/flexion, ankle dorsiflexion/plantar flexion and knee flexion/extension ROM with a goniometer | baseline and 8 weeks | 
| Change in Kinesiophobia | Tampa Scale of Kinesiophobia (TSK-11SV) used to assess changes in fear of movement | baseline and 8 weeks |