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Completed

NCT Number: NCT02781233

A Progressive Resistance Training Program in Patients With Haemophilia

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

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Key information

Conditions

Haemophilia Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Valencia

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progressive resistance training

Other

Progressive resistance training program

Normal daily activities

Other

Usual daily activities

Primary outcomes

  1. 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

  1. Change in Timed Up and Go

    Time frame: 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.

  2. Change in Haemophilia Quality of life questionnaire (A36 Haemophilia-QoL® )

    Time frame: 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).

  3. Change in Bleedings

    Time frame: daily (during the 8 weeks of intervention)

    Number of Bleedings During the study

  4. Change in viscoelastic properties (rectus femoris)

    Time frame: baseline and 8 weeks

    Myoton Pro

  5. Change in sit-to-stand test

    Time frame: 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.

  6. Change in Haemophilia Activities List questionnaire

    Time frame: 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.

  7. Change in The Haemophilia Joint Health Score (HJHS)

    Time frame: 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.

  8. Change in Pain

    Time frame: baseline and 8 weeks

    11-point numerical pain rating scale with higher score meaning higher pain

  9. Change in workability index

    Time frame: baseline and 8 weeks

    workability index with single question

  10. Change in analgesics use (days/week)

    Time frame: baseline and 8 weeks

    The number of days the participants used analgesics during the last week

  11. Change in Range Of Motion (ROM)

    Time frame: baseline and 8 weeks

    elbow extensio/flexion, ankle dorsiflexion/plantar flexion and knee flexion/extension ROM with a goniometer

  12. Change in Kinesiophobia

    Time frame: baseline and 8 weeks

    Tampa Scale of Kinesiophobia (TSK-11SV) used to assess changes in fear of movement

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Shire

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 24, 2016
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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