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

NCT02253693 | Completed DMC

• 1 other identifier: H14-23641
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Hemophilia A, Congenital

Keywords

Hemophilia A; Hemophilic arthropathy; Accelerometry

Outcome Measures

Primary Outcomes (1)

• 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.

  After 6, 12, 18 and 24 months.

Secondary Outcomes (13)

• Age (years).

  In month 0, and month 24.

• Weight (Kg).

  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).

  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).

  In Baseline and after 6, 12, 18 and 24 months.

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

  In Baseline and after 6, 12, 18 and 24 months.

Study Arms (1)

Patients with haemophilia

Adult patients with haemophilia A presenting joint disease.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with haemophilia A presenting joint disease (haemophilic arthropathy) and who are under prophylaxis treatment with FVIII

You may qualify if:

• Male patients over 18
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (2)

University of Valencia

Valencia, 46010, Spain

Location

Hospital Universitari i Politècnic La Fe de Valencia

Valencia, 46026, Spain

Location

Related Publications (3)

• Rodríguez-Merchan EC, Goddard NJ, Lee CA, editors. Musculoskeletal Aspects of Haemophilia. Oxford: Blackwell Sciencie Ltd; 2000.

  BACKGROUND

• 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.

  PMID: 21299746 BACKGROUND

• Hendelman 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.

  PMID: 10993413 BACKGROUND

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

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

Study Officials

• Felipe Querol-Fuentes

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Lecturer

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: October 1, 2014
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 9, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)