A Progressive Resistance Training Program in Patients With Haemophilia

Not Applicable

Completed

• Conditions: Haemophilia
• Interventions: Other: Progressive resistance training; Other: Normal daily activities

• Registration Number: NCT02781233
• Lead Sponsor: University of Valencia

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 Timeline

• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-24
• Study Start: 2017-10-24
• Primary Completion: 2018-06-25
• Study Completion: 2018-06-25
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-15
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training group	Progressive resistance training	Each subject will participate in 2 sessions each week during 8 weeks, with 3 days of difference (rest) between the sessions.
Control group	Normal daily activities	Usual daily activities

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.
Change in Pain	baseline and 8 weeks	11-point numerical pain rating scale with higher score meaning higher pain
Change in Kinesiophobia	baseline and 8 weeks	Tampa Scale of Kinesiophobia (TSK-11SV) used to assess changes in fear of movement
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

Trial Locations

Locations (1)

University of Valencia; 🇪🇸 Valencia, Spain