Hemophilia A, CongenitalNCT02253693
Exploratory Pilot Study of Physical Activity Monitoring in Adult Patients With Haemophilia A by Means of Accelerometry
An observational study of Hemophilia A, Congenital, run by University of Valencia at 2 sites in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hemophilia A, Congenital
- How many people
- 28 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2015to Jan 2017
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with haemophilia A presenting joint disease (haemophilic arthropathy) and who are under prophylaxis treatment with FVIII
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
University of Valencia
Valencia, 46010
Hospital Universitari i Politècnic La Fe de Valencia
Valencia, 46026
About this study
Official 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"
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.
Read the detailed description
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.
- Conditions
- Hemophilia A, Congenital
- Keywords
- Hemophilia A, Hemophilic arthropathy, Accelerometry
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with haemophilia | Adult patients with haemophilia A presenting joint disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the physiotherapy treatment compliance. Parameters: Intensity, duration, type of exercise and % of compliance.
Level of treatment compliance assessed by the intensity (counts/min), duration (m) and type of exercise measured with triaxial accelerometer.
Measured: After 6, 12, 18 and 24 months.
Secondary outcomes (13)
Age (years).
Age of patient.
Measured: In month 0, and month 24.
Weight (Kg).
Weight of patient.
Measured: In month 0, and month 24.
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).
Measured: In Baseline and after 6, 12, 18 and 24 months.
Prophylactic treatment with Factor VIII. Parameters: Trough levels of FVIII in blood (% FVIII) and type of FVIII and dose (UI/ week).
Measured: In Baseline and after 6, 12, 18 and 24 months.
Body composition of patient. Parameters: BMI (Kg/m^2) and % of body fat.
Measured: In Baseline and after 6, 12, 18 and 24 months.
Cardiovascular condition. Parameters: Beats/minute and distance covered (metres).
Beats/minute measured with a pulse monitor and distance covered in Six-minute walk test (6MWT).
Measured: In Baseline and after 6, 12, 18 and 24 months.
Blood pressure (mmHg).
Measured with Cuff- stethoscope; Manometer; manual meter.
Measured: In Baseline and after 6, 12, 18 and 24 months.
Muscle strength in kilos (peak force and time to reach peak force).
Measured with Lafayette device.
Measured: In Baseline and after 6, 12, 18 and 24 months.
State of joints and injury control (HJHS 2.1. score).
Evaluated by ultrasound system.
Measured: In Baseline and after 6, 12, 18 and 24 months.
Joint inflammation. Parameters: Thermal imaging (ºC) and joint perimeter (cm).
Measured with thermal camera and tape measure.
Measured: In Baseline and after 6, 12, 18 and 24 months.
Bone density. Parameter: Bone Quality Index (BQI).
Densitometry.
Measured: In Baseline and in month 24.
Bleeding/ hemarthrosis. Parameter: Bleeding Rate (BR).
Registered in patient's diary.
Measured: In Baseline and after 6, 12, 18 and 24 months.
Health-related quality of life. Parameters: General questionnaire (EQ-5D EuroQoL) and specific questionnaire (A36 Hemophilia QoL).
Measured: In Baseline and in 12 and 24 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hemophilia A, CongenitalStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Felipe Querol Fuentes, University of Valencia
- Investigators
- Felipe Querol-Fuentes, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253693
- Sponsor's protocol ID
- H14-23641
- Status last verified
- Jan 2018
- First submitted
- 22 Sep 2014
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rodríguez-Merchan EC, Goddard NJ, Lee CA, editors. Musculoskeletal Aspects of Haemophilia. Oxford: Blackwell Sciencie Ltd; 2000.
Gonzalez LM, Peiro-Velert C, Devis-Devis J, Valencia-Peris A, Perez-Gimeno E, Perez-Alenda S, Querol F. Comparison of physical activity and sedentary behaviours between young haemophilia A patients and healthy adolescents. Haemophilia. 2011 Jul;17(4):676-82. doi: 10.1111/j.1365-2516.2010.02469.x. Epub 2011 Feb 7.
PubMed 21299746Hendelman D, Miller K, Baggett C, Debold E, Freedson P. Validity of accelerometry for the assessment of moderate intensity physical activity in the field. Med Sci Sports Exerc. 2000 Sep;32(9 Suppl):S442-9. doi: 10.1097/00005768-200009001-00002.
PubMed 10993413
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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"
- ClinicalTrials.gov ID
- NCT02253693
- Acronym / sponsor ID
- H14-23641
- Conditions
- Hemophilia A, Congenital
- Keywords
- Hemophilia A, Hemophilic arthropathy, Accelerometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with haemophilia | – | –Adult patients with haemophilia A presenting joint disease. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with haemophilia A presenting joint disease (haemophilic arthropathy) and who are under prophylaxis treatment with FVIII
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
13 secondary outcomes
Age (years).
Time frame: In month 0, and month 24.
Weight (Kg).
Time frame: In month 0, and month 24.
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.
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.
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.
Cardiovascular condition. Parameters: Beats/minute and distance covered (metres).
Time frame: In Baseline and after 6, 12, 18 and 24 months.
Blood pressure (mmHg).
Time frame: In Baseline and after 6, 12, 18 and 24 months.
Muscle strength in kilos (peak force and time to reach peak force).
Time frame: In Baseline and after 6, 12, 18 and 24 months.
State of joints and injury control (HJHS 2.1. score).
Time frame: In Baseline and after 6, 12, 18 and 24 months.
Joint inflammation. Parameters: Thermal imaging (ºC) and joint perimeter (cm).
Time frame: In Baseline and after 6, 12, 18 and 24 months.
Bone density. Parameter: Bone Quality Index (BQI).
Time frame: In Baseline and in month 24.
Bleeding/ hemarthrosis. Parameter: Bleeding Rate (BR).
Time frame: In Baseline and after 6, 12, 18 and 24 months.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- BackgroundRodríguez-Merchan EC, Goddard NJ, Lee CA, editors. Musculoskeletal Aspects of Haemophilia. Oxford: Blackwell Sciencie Ltd; 2000.
- Background: PubMed 21299746Gonzalez LM, Peiro-Velert C, Devis-Devis J, Valencia-Peris A, Perez-Gimeno E, Perez-Alenda S, Querol F. Comparison of physical activity and sedentary behaviours between young haemophilia A patients and healthy adolescents. Haemophilia. 2011 Jul;17(4):676-82. doi: 10.1111/j.1365-2516.2010.02469.x. Epub 2011 Feb 7.
- Background: PubMed 10993413Hendelman D, Miller K, Baggett C, Debold E, Freedson P. Validity of accelerometry for the assessment of moderate intensity physical activity in the field. Med Sci Sports Exerc. 2000 Sep;32(9 Suppl):S442-9. doi: 10.1097/00005768-200009001-00002.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe Querol-Fuentes principal investigator
University of Valencia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A, Congenital, run by University of Valencia at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02253693, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018.