A Progressive Resistance Training Program in Patients With Haemophilia

Haemophilia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781233
• Other study ID #: H15-29504
• Status: Completed
• Phase: N/A
• Start date: October 24, 2017
• Est. completion date: June 25, 2018

Study information

• Verified date: October 2018
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 25, 2018
• Est. primary completion date: June 25, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Haemophilia
• Hemophilia A

Intervention

Other:
• Progressive resistance training
Progressive resistance training program
• Normal daily activities
Usual daily activities

Locations

Country	Name	City	State
Spain	University of Valencia	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	Shire

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change in Bleedings	Number of Bleedings During the study	daily (during the 8 weeks of intervention)
Secondary	Change in viscoelastic properties (rectus femoris)	Myoton Pro	baseline and 8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Pain	11-point numerical pain rating scale with higher score meaning higher pain	baseline and 8 weeks
Secondary	Change in workability index	workability index with single question	baseline and 8 weeks
Secondary	Change in analgesics use (days/week)	The number of days the participants used analgesics during the last week	baseline and 8 weeks
Secondary	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
Secondary	Change in Kinesiophobia	Tampa Scale of Kinesiophobia (TSK-11SV) used to assess changes in fear of movement	baseline and 8 weeks