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NCT Number: NCT02253693

Exploratory Pilot Study of Physical Activity Monitoring in Adult Patients With Haemophilia A by Means of Accelerometry

Research Question: Does an specific and pre-defined physical exercise prescribed by a specialist provide any benefit on haemophilic arthropathy, the quality of life or the physical condition of patients with haemophilia A and haemophilic arthropathy? Does adherence to physical exercise improve when monitoring patients with an accelerometer? Do compliant patients find higher benefit on haemophilic arthropathy, quality of life or the physical condition than non-compliant patients?

Primary Endpoint: Assess in patients with haemophilia A and haemophilic arthropathy if a prescribed and specific physical exercise monitored by an accelerometer is producing any change in the following domains: progress of haemophilic arthropathy; health-related quality of life; physical condition.

Secondary Endpoints: Evaluate the adherence to physical exercise in patients with haemophilia A and haemophilic arthropathy by means of accelerometry, and asses if compliant patients achieve higher improvement in these 3 domains than non-complaint patients.

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Key information

Conditions

Hemophilia A, Congenital 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–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Hospital Universitari i Politècnic La Fe de Valencia, Valencia, Spain

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About this study

Specific details of Treatment/Intervention:

Physical exercises that are part of the specific medical program prescribed for each patient. The exercise program for each patient will depend of the haemophilic arthropathy, the level of physical condition and the preferences of the patient.

Monitoring of physical activity will be made by means of accelerometers. Its use does not alter the daily activities and does not require any change of the patients' individual habits. The assessment of the patients' cardiovascular condition will be made using pulse monitors. Normal examinations in clinical practice will be revised as well as those specific to each patient reference health centre, muscle strength and joint use testing which will be validated with force measurement devices. Assess by means of an ultrasound system the baseline situation of the joints used for daily activities for injury control. Determine the likelihood of fracture and assess the bone quality by means of densitometry. Thermal cameras will allow to analyse the characteristics of Joint inflammation. It may be suitable for bleeding evolution control. Measurements given by densitometers will allows to determine the state of bones of the participants in the study (osteoporosis measurement). Number of bleeding events/hemarthrosis during the period of study. Determine the activity of hemarthros/synovitis using thermal images.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male patients over 18
  • Patients diagnosed with haemophilia A and under prophylaxis treatment with the same FVIII for 2 years prior to the inclusion in the study.
  • Patients with haemophilic arthropathy in, at least, one of the four load-bearing joints (knees and ankles), according to clinical and/or radiographic criteria (at least 3 in the Gilbert scale and /or at least 3 in the Pettersson scale) and/or Chronic synovitis evidenced by ultrasound.
  • Patients with signed informed consent.

Exclusion criteria

  • Patients who have developed an inhibitor antibody (≥5 Bethesda units), at the moment of the inclusion in the study.
  • Development of inhibitors
  • Modification, during follow-up, of FVIII with which the patient started the study.
  • The patient decides to withdraw voluntarily from the study.
  • Major orthopaedic surgery

Treatment and study plan

Primary outcomes

  1. Change from baseline in the physiotherapy treatment compliance. Parameters: Intensity, duration, type of exercise and % of compliance.

    Time frame: After 6, 12, 18 and 24 months.

    Level of treatment compliance assessed by the intensity (counts/min), duration (m) and type of exercise measured with triaxial accelerometer.

Secondary outcomes

  1. Age (years).

    Time frame: In month 0, and month 24.

    Age of patient.

  2. Weight (Kg).

    Time frame: In month 0, and month 24.

    Weight of patient.

  3. Biochemistry and haemogram tests. The parameters to be reported are: Leukocyte (mil/mm3), Lymphocyte (mil/mm3), Haemoglobin (g/dl), Glucose (mg/dl), Total, HDL and LDL cholesterol (mg/dl), Triglyceride (mg/dl) and Creatine phosphokinase (CPK) (UI/L).

    Time frame: In Baseline and after 6, 12, 18 and 24 months.

  4. Prophylactic treatment with Factor VIII. Parameters: Trough levels of FVIII in blood (% FVIII) and type of FVIII and dose (UI/ week).

    Time frame: In Baseline and after 6, 12, 18 and 24 months.

  5. Body composition of patient. Parameters: BMI (Kg/m^2) and % of body fat.

    Time frame: In Baseline and after 6, 12, 18 and 24 months.

  6. Cardiovascular condition. Parameters: Beats/minute and distance covered (metres).

    Time frame: In Baseline and after 6, 12, 18 and 24 months.

    Beats/minute measured with a pulse monitor and distance covered in Six-minute walk test (6MWT).

  7. Blood pressure (mmHg).

    Time frame: In Baseline and after 6, 12, 18 and 24 months.

    Measured with Cuff- stethoscope; Manometer; manual meter.

  8. Muscle strength in kilos (peak force and time to reach peak force).

    Time frame: In Baseline and after 6, 12, 18 and 24 months.

    Measured with Lafayette device.

  9. State of joints and injury control (HJHS 2.1. score).

    Time frame: In Baseline and after 6, 12, 18 and 24 months.

    Evaluated by ultrasound system.

  10. Joint inflammation. Parameters: Thermal imaging (ºC) and joint perimeter (cm).

    Time frame: In Baseline and after 6, 12, 18 and 24 months.

    Measured with thermal camera and tape measure.

  11. Bone density. Parameter: Bone Quality Index (BQI).

    Time frame: In Baseline and in month 24.

    Densitometry.

  12. Bleeding/ hemarthrosis. Parameter: Bleeding Rate (BR).

    Time frame: In Baseline and after 6, 12, 18 and 24 months.

    Registered in patient's diary.

  13. Health-related quality of life. Parameters: General questionnaire (EQ-5D EuroQoL) and specific questionnaire (A36 Hemophilia QoL).

    Time frame: In Baseline and in 12 and 24 month.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

Descriptive Pilot Study of Monitoring of Physical Activity in Adult Patients With Haemophilia A Arthropathy by Means of Accelerometry, Image Tests and Physical Condition Parameters. Benefits Associated With That Monitoring"

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 1, 2014
Registry last updated
Jan 9, 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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