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

University of Valencia1 site in 1 country20 target enrollmentOctober 24, 2017

ConditionsHaemophilia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Haemophilia
Sponsor: University of Valencia
Enrollment: 20
Locations: 1
Primary Endpoint: Change in Muscle strength
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

October 24, 2017

End Date

June 25, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

University of Valencia

Responsible Party

Principal Investigator

Felipe Querol Fuentes

Medical doctor, PhD

University of Valencia

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

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 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 Pain(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)