The Impact of Progressive Resistance Training on Quality of Life in Patients With Haemophilia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Valencia
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Muscle strength
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
Training group
Each subject will participate in 2 sessions each week during 8 weeks, with 3 days of difference (rest) between the sessions.
Intervention: Progressive resistance training (Other)
Control group
Usual daily activities
Intervention: Normal daily activities (Other)
Outcomes
Primary Outcomes
Change in Muscle strength
Time Frame: 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 Outcomes
- Change in Pain(baseline and 8 weeks)
- Change in Timed Up and Go(baseline and 8 weeks)
- Change in Haemophilia Quality of life questionnaire (A36 Haemophilia-QoL® )(baseline and 8 weeks)
- Change in Bleedings(daily (during the 8 weeks of intervention))
- Change in viscoelastic properties (rectus femoris)(baseline and 8 weeks)
- Change in sit-to-stand test(baseline and 8 weeks)
- Change in Haemophilia Activities List questionnaire(baseline and 8 weeks)
- Change in The Haemophilia Joint Health Score (HJHS)(baseline and 8 weeks)
- Change in Kinesiophobia(baseline and 8 weeks)
- Change in workability index(baseline and 8 weeks)
- Change in analgesics use (days/week)(baseline and 8 weeks)
- Change in Range Of Motion (ROM)(baseline and 8 weeks)
Investigators
Felipe Querol Fuentes
Medical doctor, PhD
University of Valencia