Clinical trial NCT02781233: A Progressive Resistance Training Program in Patients With Haemophilia
Official title: The Impact of Progressive Resistance Training on Quality of Life in Patients With Haemophilia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Haemophilia
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Shire
First posted: 2016-05-24
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Muscle strength
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Change in Timed Up and Go
timeFrame: baseline and 8 weeks
measure: Change in Haemophilia Quality of life questionnaire (A36 Haemophilia-QoL® )
timeFrame: baseline and 8 weeks
measure: Change in Bleedings
timeFrame: daily (during the 8 weeks of intervention)
measure: Change in viscoelastic properties (rectus femoris)
timeFrame: baseline and 8 weeks
measure: Change in sit-to-stand test
timeFrame: baseline and 8 weeks
measure: Change in Haemophilia Activities List questionnaire
timeFrame: baseline and 8 weeks
measure: Change in The Haemophilia Joint Health Score (HJHS)
timeFrame: baseline and 8 weeks
measure: Change in Pain
timeFrame: baseline and 8 weeks
measure: Change in workability index
timeFrame: baseline and 8 weeks
measure: Change in analgesics use (days/week)
timeFrame: baseline and 8 weeks
measure: Change in Range Of Motion (ROM)
timeFrame: baseline and 8 weeks
measure: Change in Kinesiophobia
timeFrame: baseline and 8 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: University of Valencia
name: Felipe Querol-Fuentes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calatayud J, Perez-Alenda S, Carrasco JJ, Cruz-Montecinos C, Andersen LL, Bonanad S, Querol F, Megias-Vericat JE, Casana J. Safety and Effectiveness of Progressive Moderate-to-Vigorous Intensity Elastic Resistance Training on Physical Function and Pain in People With Hemophilia. Phys Ther. 2020 Aug 31;100(9):1632-1644. doi: 10.1093/ptj/pzaa106.